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Regulatory

Approvals, filings, CRLs, breakthrough designations and advisory committees.

323 picksRelatedFDANMPA / CDEPolicy & payment

Latest picks

41–57 of 323
Oct 9Fri
  1. WeChat73

    FDA Approves Bristol Myers Squibb's Mavacamten for Symptomatic Obstructive HCM in Patients Weighing 30 kg or More

    The FDA has approved Bristol Myers Squibb's mavacamten to improve functional capacity and symptoms in children and adults weighing 30 kg (66 lb) or more who have symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The approval is based on positive results from the Phase 3 SCOUT-HCM trial and extends the drug's existing clinical evidence in adult oHCM. Mavacamten is the only FDA-approved drug for pediatric oHCM.

    Why it matters: First FDA approval extending mavacamten, the only approved pediatric oHCM drug, to children.

  2. WeChat77

    NMPA Approves Beijing Bailian Medical's Transcatheter Pulmonary Valve System

    China's National Medical Products Administration has approved the innovative device registration application for the transcatheter pulmonary valve system of Beijing Bailian Medical Technology. The system, comprising a delivery system with a delivery catheter and loader, is placed via a small transthoracic incision. It is indicated for patients aged at least 9 years and weighing at least 20 kg with severe pulmonary regurgitation and a native right ventricular outflow tract after surgery for complex congenital heart disease.

    Why it matters: NMPA approval of a domestically developed transcatheter pulmonary valve adds a new interventional option for post-surgical congenital heart disease patients.

  3. WeChat67

    FDA Approves Pfizer's TUKYSA Plus Trastuzumab and Pertuzumab for First-Line HER2+ Breast Cancer Maintenance

    The FDA approved Pfizer's TUKYSA (tucatinib) combined with trastuzumab and pertuzumab as maintenance therapy after induction treatment for adults with unresectable locally advanced or metastatic HER2-positive breast cancer. The approval extends TUKYSA into the first-line setting and offers a chemotherapy-free maintenance option. According to Pfizer, the regimen reduced the risk of death by 35.9% compared with trastuzumab alone.

    Why it matters: FDA approval moves Pfizer's TUKYSA into first-line HER2+ breast cancer maintenance with a 35.9% death-risk reduction.

  4. U.S. FDA93

    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. WeChat79

    FDA Approves Novartis Remibrutinib for Symptomatic Dermographism in Adults

    The FDA has approved Novartis' Rhapsido (remibrutinib) for adults with symptomatic dermographism whose symptoms are not adequately controlled by H1 antihistamines. The decision on October 7, 2026, follows the drug's September 2025 approval in chronic spontaneous urticaria, making Rhapsido the only prescription medicine approved for both of the most common chronic urticaria types.

    Why it matters: Expands the first targeted therapy for symptomatic dermographism into a second common urticaria indication.

  2. WeChat77

    AstraZeneca's Datroway Approved in China for Metastatic Triple-Negative Breast Cancer Untreatable with PD-1/PD-L1 Inhibitors

    AstraZeneca's TROP2-targeted antibody-drug conjugate Datroway (dedatopotamab) has been approved in China for unresectable or metastatic triple-negative breast cancer in patients not suitable for PD-1/PD-L1 inhibitor treatment. In the phase III TROPION-Breast02 study, the drug extended median overall survival by 5 months versus chemotherapy chosen by investigators (hazard ratio = 0.79; 95% confidence interval: 0.64-0.98; p=0.0291), reaching a median OS of nearly two years. It is described as the first and only TROP2 ADC approved for this indication with an OS benefit, and Datroway now has two approved breast cancer indications in China.

    Why it matters: China approval adds an OS-proven TROP2 ADC option for a triple-negative breast cancer setting lacking PD-1/PD-L1 treatment.

  3. WeChat74

    NMPA Approves GeneScience's Six-Month Leuprolide Injection for Prostate Cancer Androgen Deprivation

    Changchun GeneScience Pharmaceutical received NMPA approval, dated 29 September, for its 5.1-class leuprolide mesylate injection (6M), a 42mg ready-to-use in-situ gel depot given subcutaneously every 24 weeks, for prostate cancer requiring androgen deprivation therapy. In a US Phase 3 trial of 137 patients, the 6-monthly 42mg dose achieved a 97% castration rate (testosterone at or below 50ng/dL) at day 28 and through days 28 to 336; a Chinese bridging study at 43 sites in 142 patients showed a 97.9% cumulative probability of maintaining castrate testosterone levels. The product will compete with Livzon's three-month microsphere formulation.

    Why it matters: A six-month leuprolide depot adds a longer-acting androgen deprivation option for prostate cancer in China.

  4. Nature Biotechnology66

    Regeneron approval brings relief for 'second skeleton' bone disorder.

    Regeneron has received approval for a treatment for the 'second skeleton' bone disorder, a condition in which bone forms progressively in soft tissue. The approval marks the first regulatory decision for this indication for the company. No dosing, pricing or trial details were disclosed.

    Why it matters: First approval for a Regeneron therapy in a rare progressive bone disorder.

  5. U.S. FDA80

    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.

  6. U.S. FDA55

    Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing

    The FDA's Center for Drug Evaluation and Research issued a draft guidance on studying pharmacokinetics, and where appropriate pharmacodynamics, in patients with impaired hepatic function, including for therapeutic biological products. The non-binding recommendations cover study design, data analysis and impact on dosing for sponsors and applicants. Comments are due by 12/01/2026 under docket FDA-2026-D-8693 before work begins on the final version.

    Why it matters: Draft FDA guidance sets expectations for hepatic impairment PK studies that shape sponsors' clinical development plans.

Oct 7Wed
  1. STAT53

    STAT+: Merck suffers a setback in Europe over its new Keytruda formulation

    A Dutch court ruled that Merck infringed a Halozyme Therapeutics patent covering a subcutaneous formulation of Keytruda and ordered the company to stop manufacturing and marketing that version in several European countries, including France, Italy, Sweden, Switzerland and the Netherlands. The decision is part of a widening patent dispute over the cancer treatment. Patients can still access the intravenous version, which is unaffected by the order. Merck was asked for comment.

    Why it matters: Court-ordered halt of a subcutaneous Keytruda formulation affects sales in several European markets.

  2. WeChat75

    FDA Approves AbbVie's Tavapadon (Juvmo) for Adults with Parkinson's Disease

    The FDA has approved AbbVie's tavapadon, brand name Juvmo, for the treatment of Parkinson's disease in adults. Tavapadon is a once-daily oral tablet and the first selective partial agonist targeting the dopamine D1/D5 receptor subtypes. AbbVie says more than 11 million people worldwide have Parkinson's disease.

    Why it matters: First approval of a selective D1/D5 partial agonist adds a new mechanism for Parkinson's disease.

  3. JAMA Network78

    FDA Authorizes First Autonomous Robotic Blood Draw Device

    The FDA has authorized the first stand-alone robotic blood draw device for autonomous use in adults in outpatient settings, marking the first approval for this class of automated blood collection device. The source provides only summary-level information and does not disclose the manufacturer, model, or a 510(k) or De Novo submission number.

    Why it matters: As the first FDA-authorized autonomous outpatient blood draw device for adults, it offers a reference point for review pathways for similar automated devices.

Oct 6Tue
  1. BioSpace48

    FDA extends review of Novo’s hemophilia A drug, citing manufacturing issues

    The FDA has extended its review of Novo's denecimig, an investigational bispecific antibody and next-gen factor VIII mimetic for prophylactic treatment of hemophilia A, citing ongoing facility remediation activities at an unnamed manufacturing site. The agency flagged no efficacy or safety deficiencies, and Novo, which submitted the drug in September 2025 with a decision originally slated for the third quarter, says it is addressing the FDA's requests and still preparing for a 2027 launch in adults and children. The FDA has not shared a new review timeline, and European regulators are also evaluating the programme.

    Why it matters: FDA manufacturing delay affects a potential hemophilia A approval and ties into Novo's broader Catalent-related quality problems.

  2. U.S. FDA46

    TCI Co., Ltd BioCosme PABP BRANCH - 736888 - 09/02/2026

    FDA issued a warning letter to TCI Co., Ltd BioCosme PABP BRANCH, a contract manufacturer of over-the-counter drugs in Pingtung County, Taiwan, citing significant CGMP violations found during an inspection from March 9 to 13, 2026. The firm released OTC drug batches to the U.S. market without assay testing of the active ingredient and failed to perform identity testing on incoming APIs and raw materials or verify supplier certificates of analysis. FDA found the firm's April 2, 2026 response to its Form FDA 483 inadequate and required a comprehensive quality agreement and lists of test methods and specifications; failure to correct the violations may bring regulatory action without further notice.

    Why it matters: FDA warning letter documents CGMP failures at an OTC contract manufacturer supplying the U.S. market.

  3. U.S. FDA55

    Walmart, Inc. - 736557 - 10/01/2026

    FDA's Center for Drug Evaluation and Research issued a warning letter dated October 1, 2026 to Walmart President and CEO John Furner over three products sold on walmart.com: HClear for him, Herstat GST, and Terragen HG Formula. Purchased by FDA in July 2026 and shipped via Walmart Fulfillment Services, the products are marketed for genital herpes and genital sore symptoms and are unapproved new drugs under section 505(a) of the FD&C Act. FDA notes no OTC drug product is approved for treating any STI and warns that failure to correct the violations may bring seizure or injunction without further notice.

    Why it matters: FDA targets a major retailer for selling unapproved STI products, a direct compliance risk for online drug marketplaces.

  4. U.S. FDA56

    Amazon.com, Inc. - 736006 - 10/01/2026

    FDA's Center for Drug Evaluation and Research sent a warning letter dated October 1, 2026 (reference 736006) to Amazon CEO Andy Jassy, citing nine products sold on amazon.com and fulfilled via Fulfillment by Amazon, including FemiClear, HClear for him, HerpCare Ointment and Spray, and RoyceDerm Herpes Relief Cream, as unapproved new drugs for genital herpes under section 505(a) of the FD&C Act. FDA, which purchased the products in July 2026, notes no OTC drug is approved for treating any STI and warns that reliance may delay care and risk infertility, sepsis and death. Amazon must correct the violations or face regulatory or legal action including seizure and injunction.

    Why it matters: FDA warning letter puts Amazon's marketplace and Fulfillment by Amazon service directly in the regulatory line for unapproved STI drugs.

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