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Oct 15Thu
  1. ema.europa.eu90

    EMA recommends authorisation of Rasonque for metastatic pancreatic cancer

    EMA's CHMP has recommended EU marketing authorisation for Revolution Medicines' Rasonque (daraxonrasib), an oral RAS inhibitor for adults with metastatic pancreatic adenocarcinoma previously treated at least once. In a 500-patient phase 3 study, median overall survival was 12.4 months versus 6.7 with chemotherapy, and median progression-free survival 7.2 versus 3.6 months. The European Commission will now fast-track its decision, with pricing left to Member States.

    Why it matters: CHMP backing via a phased review under 150 days sets precedent for faster EU assessments of priority cancer medicines.

  2. medicalxpress.com53

    Expanded genetic testing and early transplant referrals anchor new myelofibrosis care recommendations

    The American Society of Hematology has issued 10 evidence-based recommendations for managing myelofibrosis, a rare blood cancer affecting up to six per 100,000 people, published in Blood Advances. The guidelines call for extended molecular testing at diagnosis, early transplant consultation for higher-risk patients responding to JAK inhibitors, appropriate JAK inhibitor use by risk level, anemia management strategies, and low-dose aspirin for patients with the JAK2 V617F mutation. Panel chair Brady Stein says the panel hopes the questions posed will set a future research agenda on treatment prediction, anemia and transplant timing.

    Why it matters: First ASH guidelines covering myelofibrosis care decisions from testing to transplant will shape clinical practice in a rare cancer.

Oct 14Wed
  1. fda.gov91

    FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer

    The FDA expanded approval of Anktiva (nogapendekin alfa inbakicept-pmln), given with BCG, to adults with BCG-unresponsive, high-grade papillary-only non-muscle invasive bladder cancer, the first FDA-approved treatment for that disease. The decision relied on evidence from Anktiva's earlier approval for carcinoma in situ, where a trial showed a majority of adults achieved a complete response and many maintained it for at least 12 months. The FDA is finalizing draft guidance to let developers use CIS study evidence for papillary-only NMIBC approvals.

    Why it matters: FDA extends Anktiva to BCG-unresponsive papillary-only NMIBC and sets a precedent for cross-indication evidence use.

  2. fda.gov76

    FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer

    On October 14, 2026, the FDA expanded approval of nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, an ImmunityBio subsidiary) with BCG to cover adults with BCG-unresponsive non-muscle invasive bladder cancer with high-grade papillary-only tumors, beyond the prior indication limited to carcinoma in situ. The agency extrapolated efficacy from Cohort A of QUILT-3.032, a single-arm trial of 77 patients, which showed a complete response rate of 62%. The recommended dose is 400 mcg intravesically with BCG weekly for 6 weeks induction, followed by maintenance for up to 37 months.

  3. medicalxpress.com57

    WHO experts recommend HPV shot for girls aged 4–8

    WHO's Strategic Advisory Group of Experts on Immunisation (SAGE) has recommended that countries consider routine HPV vaccination for girls as young as 4 if it boosts uptake, after confirming a single-dose schedule for girls aged 9 to 14 as the most efficient route to the 90% coverage target. Global HPV vaccine coverage stands at 33% across 165 introducing countries, while more than 95 million girls had been vaccinated by the end of 2025. SAGE also set priority groups for expanding single-dose vaccination: catch-up for women up to 25, then up to 30, routine vaccination of boys aged 9 to 14, and catch-up for males up to 20.

    Why it matters: SAGE guidance shapes national HPV vaccination policy as coverage remains far below the 90% target.

Oct 13Tue
  1. nature.com84

    RevMed’s pancreatic cancer drug first

    The FDA approved Revolution Medicines' Rasonque (daraxonrasib) in August for metastatic pancreatic adenocarcinoma, making it a first-in-class RAS inhibitor for the most common form of pancreatic cancer. Rasonque uses a molecular glue mechanism, binding cyclophilin A and RAS in its GTP-bound 'on' state, unlike KRAS G12C inhibitors such as Lumakras and Krazati. An early-stage trial in September showed promise in lung cancer, raising hopes for use in other hard-to-treat tumors.

    Why it matters: First FDA approval of a pan-RAS inhibitor for metastatic pancreatic adenocarcinoma, with early lung cancer activity.

Oct 9Fri
  1. fda.gov93

    FDA approves atezolizumab in combination with chemotherapy for Stage III mismatch repair deficient colon cancer

    The FDA approved atezolizumab (Tecentriq, Genentech) in combination with a fluoropyrimidine and oxaliplatin on October 8, 2026, for adjuvant treatment of Stage III mismatch repair deficient colon cancer in patients two years of age and older, with the subcutaneous Tecentriq Hybreza approved for those 12 years and older weighing 40 kg or greater. In the ATOMIC trial of 711 adults and one pediatric patient, the hazard ratio for disease-free survival was 0.50 versus mFOLFOX6 alone, and median DFS was not reached in either arm. Reviews are ongoing at partner agencies under Project Orbis.

    Why it matters: FDA approval of atezolizumab plus chemotherapy as adjuvant therapy for Stage III dMMR colon cancer, with a disease-free survival hazard ratio of 0.50.

Oct 8Thu
  1. fda.gov80

    FDA approves tucatinib with trastuzumab and pertuzumab for the maintenance treatment of HER2-positive breast cancer

    The FDA approved tucatinib (Tukysa, Seagen, a Pfizer subsidiary) with trastuzumab and pertuzumab on October 7, 2026, for maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer after induction therapy. In the 654-patient HER2CLIMB-05 trial, median progression-free survival was 24.9 months with tucatinib 300 mg twice daily versus 16.3 months with placebo (HR 0.64, p<0.0001). The label carries a boxed warning for hepatotoxicity; overall survival data were immature.

    Why it matters: FDA approval extends tucatinib to first-line maintenance, with PFS results from a randomized phase 3 trial.

Oct 7Wed
  1. fda.gov40

    Rare Disease Drug Approvals

    FDA's CDER lists recent rare disease drug approvals on its Accelerating Rare Disease Cures Program page. In 2026 alone these include Camzyos for an inherited heart condition in children, Emcitate for MCT8 deficiency, Isembyld for muscle loss in spinal muscular atrophy, and Zanvastro for Alexander Disease, among others. The list spans 2021 to 2026 and links to the underlying FDA news releases.

Oct 5Mon
  1. statnews.com43

    STAT+: Lilly’s Jaypirca approved as first-line CLL therapy

    The FDA has approved Eli Lilly's Jaypirca as a first-line therapy for chronic lymphocytic leukemia (CLL), according to STAT News. The approval moves Jaypirca, already known in CLL treatment discussions, into the earlier-line setting. Details of the decision are behind the STAT+ paywall, with further coverage available to subscribers.

    Why it matters: First-line CLL approval expands the eligible patient population for Lilly's Jaypirca.

Oct 3Sat
  1. fda.gov50

    Oncology (Cancer)/Hematologic Malignancies Approval Notifications

    The FDA issued a run of oncology and hematology approvals from July 31 to October 2, 2026. They include pirtobrutinib (Jaypirca, Eli Lilly) for previously untreated CLL or SLL without 17p deletion on October 2, belzutifan plus lenvatinib for advanced clear-cell renal cell carcinoma on September 24, lirafugratinib (Lyrfigtu, Elevar) for FGFR2-rearranged cholangiocarcinoma on September 23, imlunestrant plus abemaciclib for ESR1-mutated breast cancer on September 18, and daraxonrasib (RASONQUE, Revolution Medicines) for metastatic pancreatic adenocarcinoma on August 26. Accelerated approvals in the batch cover sevabertinib for HER2-mutated NSCLC, camizestrant for ESR1-mutated breast cancer, iberdomide for multiple myeloma, and vusolimogene oderparepvec plus nivolumab for melanoma.

Oct 2Fri
  1. aacrjournals.org80

    In Regulatory First, Myeloma Drug Approved Based on MRD Negativity

    The FDA has approved iberdomide for multiple myeloma on the basis of minimal residual disease negativity, the first approval for the disease to use that endpoint. Iberdomide also represents a new generation of targeted protein degraders, with several more potent cereblon E3 ligase modulators already in clinical development.

    Why it matters: First myeloma approval based on MRD negativity and a new class of cereblon E3 ligase modulators advancing.

Oct 1Thu
  1. BioCentury59

    I-DXd withdrawal thins October PDUFA calendar

    Merck & Co. and Daiichi Sankyo withdrew their BLA for ifinatamab deruxtecan two weeks before its PDUFA date; the partners had sought accelerated approval for extensive-stage small cell lung cancer in patients whose disease progressed on platinum chemotherapy. The withdrawal leaves at least five FDA decisions on the PDUFA calendar for October. The article does not state what the companies plan to do next with the programme.

    Why it matters: A BLA withdrawal by Merck and Daiichi Sankyo cuts October's expected FDA decision count to five.

Sep 30Wed
  1. biospace.com50

    Merck, Daiichi Sankyo retract accelerated approval request for lung cancer ADC

    Merck and Daiichi Sankyo have voluntarily withdrawn their accelerated approval application for the antibody-drug conjugate ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer after platinum-based chemotherapy, after the FDA said the data did not satisfy requirements for the proposed indication. The application rested on a 48.2% confirmed objective response rate from the Phase 2 IDeate-Lung01 study. A Phase 3 trial in ES-SCLC with enrollment nearing completion continues and could support a future filing.

    Why it matters: Voluntary withdrawal of an accelerated approval application narrows the regulatory path for a key Merck-Daiichi Sankyo ADC.

Sep 28Mon
  1. biopharmadive.com56

    Merck, Daiichi end plans to seek speedy approval of lung cancer ADC

    Merck & Co. and Daiichi Sankyo withdrew their U.S. application for accelerated approval of ifinatamab deruxtecan, or I-DXd, in extensive-stage small-cell lung cancer after the FDA indicated Phase 2 response rate data were insufficient; a decision had been expected by Oct. 10. The B7-H3-targeting drug is still being tested against chemotherapy in relapsed disease, a trial in which recruitment was temporarily halted last year after higher than anticipated deaths from a serious lung condition. Competing B7-H3 drugs licensed to GSK (riz-rez) and Roche (tam-peli) have advanced, and I-DXd is also in Phase 3 testing in prostate cancer and esophageal squamous cell carcinoma.

    Why it matters: A rejected accelerated approval reshapes the B7-H3 race in small-cell lung cancer among Merck, GSK and Roche.

  2. bsky.app47

    Signal or noise? > Merck, Daiichi pull lung cancer filing after FDA pushback deals another blow to $4B deal >> Comment below! #strategy #competitiveintelligence #marketing #pharma #pharmaceutical #biotech #healthcare #competitivemarketing

    Merck and Daiichi have withdrawn a lung cancer filing after pushback from the FDA. The withdrawal deals another blow to their $4 billion deal. No further trial details, drug name or next steps were given in the available material.

Sep 24Thu
  1. fiercebiotech.com56

    Grail survives adcomm vote as it awaits FDA decision for cancer blood test

    FDA advisors have voted to recommend Grail's multi-cancer blood test Galleri, despite a major trial setback earlier this year and ongoing questions over its efficacy. Grail now awaits an FDA decision on the test. The outcome leaves the company positioned for a potential approval ahead.

    Why it matters: FDA advisor backing shapes the pending decision on a multi-cancer early detection test.

  2. STAT News59

    STAT+: FDA advisory panel endorses Grail blood test for cancer, saying benefits outweigh risks

    An FDA advisory panel endorsed Galleri, Grail's blood test to screen for multiple types of cancer, voting 10 to 0 that there is reasonable assurance the test is safe. The panel split 6 to 4 on effectiveness and voted 7 to 2 with one abstention that benefits outweigh risks for patients meeting the proposed indication's criteria. The FDA is not obliged to follow the panel's advice but often does.

    Why it matters: Advisory panel backing moves a multi-cancer screening blood test closer to potential FDA decision.

Sep 22Tue
  1. STAT News43

    STAT+: Lilly’s breast cancer combo wins approval

    The FDA approved Eli Lilly's combination drug treatment for patients with an advanced form of breast cancer, reported Sept. 21, 2026. The decision gives Lilly a new option in the advanced breast cancer setting. Full details of the approval are available to STAT+ subscribers.

    Why it matters: FDA approval of a Lilly combination therapy for advanced breast cancer directly affects oncology treatment options.

Sep 19Sat
  1. BioCentury57

    EMA’s CHMP backs eight new medicines in September

    EMA's CHMP issued positive opinions for eight new medicines at its September meeting, including two small molecules for ovarian cancer, a potential first daily oral therapy for some adults with hidradenitis suppurativa, and a GLP-2R agonist for short bowel syndrome that FDA previously rebuffed, plus two biosimilars and two generics. Among them is Lifyorli relacorilant, Corcept Therapeutics' selective glucocorticoid receptor antagonist, recommended with nab-paclitaxel for adults with platinum-resistant, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who have had one to three prior systemic regimens. EU approval decisions from the European Commission follow.

    Why it matters: Eight EU approval recommendations at once include new ovarian cancer options and a potential first oral hidradenitis suppurativa drug.

Sep 18Fri
  1. ema.europa.eu40

    Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2026

    The EMA's CHMP recommended 12 new medicines for approval at its September 2026 meeting, including Frehemgo (denecimig) for bleeding prophylaxis in haemophilia A, Gevalka (ensartinib) for ALK-positive advanced non-small cell lung cancer, and Povofortay (povorcitinib), the first oral daily treatment for adults with hidradenitis suppurativa refractory or intolerant to anti-TNF therapy. Two initial marketing authorisation applications were withdrawn, Isembyld for 5q spinal muscular atrophy and Zinmyleo for chemotherapy-induced myelosuppression. Re-examinations of negative opinions for Kemsu, Meplyffa and Qezzaqar will follow once grounds are received.

Sep 17Thu
  1. STAT News57

    STAT+: England to cover AstraZeneca breast cancer drug, a result of U.K.-U.S. drug pricing deal

    English health authorities agreed to provide AstraZeneca's Enhertu through the NHS for women with metastatic breast cancer whose tumors have low levels of HER2, ending a years-long dispute. The decision extends the antibody-drug conjugate to an estimated 1,000 people in England and follows a U.S.-U.K. drug pricing deal under which a U.K. health agency raised cost-effectiveness thresholds. Scotland has covered the drug since 2023, as have 26 other European countries.

Sep 15Tue
  1. fiercepharma.com61

    FDA approves first radioligand equivalent, Curium’s copycat of Novartis’ Lutathera

    The FDA has approved Bexlutry, Curium's lutetium Lu 177 dotatate injection, as the industry's first radioligand equivalent. The approval for the Boston company follows a court ruling that cleared Curium of all patent claims brought by Novartis, whose reference product is Lutathera.

    Why it matters: First FDA-approved radioligand equivalent, a copycat of Novartis' Lutathera, after Novartis lost its patent case.

  2. fiercebiotech.com66

    After rejection, FDA approves Telix’s Pixclara, the first FET-PET imaging drug for brain cancer

    The FDA has approved Telix's Pixclara (floretyrosine F 18, or 18F-FET), the first FET-PET imaging drug for glioma approved in the U.S., more than a year after rejecting the application in April over a need for additional confirmatory clinical evidence. The diagnostic, used with PET to distinguish recurrent or progressive glioma from treatment-related change, is approved for adults and children one month of age and older. Gliomas account for around 80% of malignant brain tumors, with around 24,000 U.S. cases yearly.

    Why it matters: First FDA-approved FET-PET imaging drug for glioma fills a guideline-recommended diagnostic gap in the U.S.

Sep 11Fri
  1. nature.com61

    Selective oestrogen receptor degrader class grows with new cancer approval

    The FDA has approved AstraZeneca's camizestrant (Etcamah), a selective oestrogen receptor degrader, as part of a combination therapy for a subset of breast cancer patients. The drug targets patients whose tumours have acquired resistance mutations to aromatase inhibitors. It expands the SERD class of therapies.

    Why it matters: FDA approval of a new SERD widens treatment options for aromatase inhibitor-resistant breast cancer.

Sep 10Thu
  1. nature.com44

    FDA approves oncolytic virus

    The FDA approved Replimune's oncolytic immunotherapy Tudriqev (vusolimogene oderparepvec), formerly RP1, in August for unresectable advanced melanoma that has progressed after PD-1 immunotherapy. The engineered HSV-1 virus encodes GM-CSF and the fusogenic GALV-GP-R glycoprotein to spread through tumours. It is the second oncolytic virus approved, after Amgen's Imlygic (talimogene laherparepvec).

    Why it matters: Only the second oncolytic virus ever approved by FDA, expanding options in post-PD-1 advanced melanoma.

  2. fiercepharma.com55

    FDA clears Bayer’s Hyrnuo in first-line lung cancer, amping up Hernexeos rivalry

    The FDA has approved Bayer's tyrosine kinase inhibitor Hyrnuo for first-line treatment of patients with HER2-mutant non-small cell lung cancer. The approval comes roughly half a year after the FDA cleared Boehringer Ingelheim's rival TKI Hernexeos for a similar setting. The two drugs now compete in the same indication.

    Why it matters: First-line FDA approval in HER2-mutant NSCLC sets up direct competition between Bayer and Boehringer Ingelheim TKIs.

Sep 8Tue
  1. statnews.com49

    A breakthrough pancreatic cancer drug won approval. They still struggle to access it

    FDA approval of Rasonque, Revolution Medicines' pancreatic cancer drug that nearly doubles median overall survival, closed the company's expanded access program, leaving patients mid-process without coverage. Commercial insurers like Aetna and Medicare Part D plans take weeks or months to set up coverage, with one Medicare denial reversed only after OptumRx approved prior authorization. Patients such as Juan Solano, who has metastatic disease, remain caught in the gap.

    Why it matters: Approval of Rasonque exposes a coverage gap that blocks pancreatic cancer patients from a survival-doubling drug.

Sep 5Sat
  1. fda.gov59

    FDA Grants Accelerated Approval to a New Breast Cancer Treatment

    The FDA granted accelerated approval to AstraZeneca's Etcamah (camizestrant), an oral tablet, combined with a CDK4/6 inhibitor (abemaciclib, palbociclib or ribociclib) for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer whose tumors show an ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, detected by the FDA-authorized Guardant360 CDx companion diagnostic. In the pivotal trial, estimated median progression-free survival was 16 months versus 9.2 months for continuing an aromatase inhibitor plus a CDK4/6 inhibitor. The label carries a boxed warning for irregular heart rhythm, and confirmatory trials are required to verify clinical benefit.

    Why it matters: First FDA approval of a cancer therapy guided by ctDNA resistance-mutation detection before imaging shows progression.

Sep 4Fri
  1. nature.com65

    Newest glue degrader nabs multiple myeloma approval

    Bristol Myers Squibb won accelerated approval for iberdomide (Zenbexus) in combination with daratumumab and hyaluronidase (Darzalex Faspro) and dexamethasone for multiple myeloma patients who have received at least one prior line of therapy. Iberdomide is the newest of BMS's molecular glue degraders to reach the market.

    Why it matters: Accelerated approval of a new glue degrader expands the multiple myeloma treatment landscape.

Sep 3Thu
  1. fiercepharma.com42

    FDA files reveal lingering concerns, contrasting views behind Replimune melanoma nod

    FDA leaders at the Office of Clinical Evaluation and the Oncology Center of Excellence overruled review staffers' concerns, clearing the way for Replimune's accelerated approval of Tudriqev in melanoma last month. FDA files show contrasting views within the agency ahead of the decision. The approval stands, with internal review documents now surfacing the earlier disagreements.

Sep 1Tue
  1. aacrjournals.org61

    First CAR T-Cell Therapy Approved for Solid Tumors

    China has approved satricabtagene autoleucel (satri-cel), the first CAR T-cell therapy for solid tumors, for patients with claudin 18.2-positive, HER2-negative gastric or gastro-esophageal junction cancer. The approval is based on a phase II trial showing improved progression-free and overall survival. Scientists welcome the decision but say more research is needed to improve CAR T-cell effectiveness against solid tumors.

    Why it matters: First regulatory approval of a CAR T-cell therapy for a solid tumor indication.

Aug 27Thu
  1. nature.com79

    RevMed’s RAS inhibitor gains landmark FDA approval for pancreatic cancer

    The US FDA has approved Revolution Medicines' daraxonrasib (Rasonque) for pancreatic adenocarcinoma patients who have received at least one prior systemic therapy or are not eligible for multiagent systemic therapy. It is the first broadly active RAS-targeted inhibitor to reach market, unlike the KRAS G12C-specific inhibitors sotorasib (Lumakras) and adagrasib (Krazati), which are approved only in NSCLC and colorectal cancer subsets.

    Why it matters: First approval of a broadly active RAS inhibitor, in a hard-to-treat pancreatic cancer setting.

  2. biocentury.com75

    RevMed’s first-in-class pancreatic therapy among fastest CNPV approvals

    FDA approved Revolution Medicines' daraxonrasib (Rasonque) for pancreatic ductal adenocarcinoma, making it the first targeted therapy in the new RAS(ON) inhibitor class and the first new cancer drug cleared under the commissioner's national priority review voucher initiative. Revolution Medicines (NASDAQ:RVMD) is launching the drug immediately at a WAC of $39,800 for a 30-day supply.

    Why it matters: First approval in a new drug class and first under FDA's new priority voucher programme, priced at launch.

  3. statnews.com85

    STAT+: FDA approves new pancreatic cancer drug expected to usher in new era of treatment

    The FDA approved daraxonrasib, brand name Rasonque, from Revolution Medicines as a second-line treatment for advanced pancreatic cancer, making it the first drug to attack a genetic cause of the disease. In the supporting trial, patients on Rasonque achieved median overall survival of 13.2 months versus 6.7 months on standard chemotherapy. Clinicians described it as the biggest development in pancreatic cancer in decades.

    Why it matters: First approval of a genetically targeted therapy for advanced pancreatic cancer, with survival nearly doubled.

Aug 26Wed
  1. FiercePharma68

    FDA greenlights Revolution Medicines' pancreatic cancer gamechanger

    The FDA has approved Revolution Medicines' Ras inhibitor daraxonrasib for metastatic pancreatic cancer. The decision follows data presented at the American Society of Clinical Oncology meeting in May. Daraxonrasib targets Ras in a disease setting with limited options.

    Why it matters: FDA approval of a new Ras inhibitor for metastatic pancreatic cancer matters to clinicians and industry readers.

  2. fiercebiotech.com72

    FDA greenlights Revolution Medicines' pancreatic cancer gamechanger

    The FDA has approved Revolution Medicines' Ras inhibitor daraxonrasib for metastatic pancreatic cancer. The decision follows data presented at the American Society of Clinical Oncology meeting in May. Daraxonrasib now becomes an FDA-approved option for patients with this indication.

    Why it matters: First FDA approval of a Ras inhibitor for metastatic pancreatic cancer matters to oncologists and drug developers.

  3. fda.gov74

    FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer

    The FDA approved Revolution Medicines' Rasonque (daraxonrasib), a once-daily RAS inhibitor, for adults with metastatic pancreatic adenocarcinoma who have had at least one prior systemic therapy or are not candidates for multiagent systemic therapy. In a 500-patient randomized trial, Rasonque improved median overall survival to 13.2 months versus 6.7 months on standard chemotherapy. The approval came 6.5 months ahead of the user fee deadline, under Breakthrough Therapy, Orphan Drug and Priority Review designations and the National Priority Voucher pilot program.

    Why it matters: First-in-class RAS inhibitor approval gives a survival benefit in metastatic pancreatic adenocarcinoma, a high-mortality cancer with few options.

Aug 21Fri
  1. fiercepharma.com47

    Xspray's Dasynoc approval bid foiled again by FDA's manufacturer concerns

    The FDA has issued Xspray Pharma a third Complete Response Letter for Dasynoc, its optimized version of Bristol Myers Squibb's Sprycel (dasatinib) for chronic myeloid leukemia and acute lymphoblastic leukemia. The letter cites manufacturing observations at third-party producer NerPharMa in Italy and requests additional commercial-scale batch data; the FDA has yet to decide whether a reinspection is needed. Xspray plans to resubmit the application before the end of the year and continues U.S. launch preparations.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org