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FDA

FDA approvals, CRLs, advisory committees, clinical holds and guidance — every shift in the U.S. regulatory posture.

263 picksRelatedEMA / CHMPNMPA / CDERegulatory

Latest picks

41–59 of 263
Oct 11Sun
  1. WeChat63

    FDA Approves First Oral HSV Antiviral With New Mechanism in Nearly 30 Years

    The FDA has approved the first HSV treatment with a new mechanism of action in nearly 30 years, an oral antiviral drug. It offers a new option for high-risk patients whose HSV infections have failed standard antiviral therapy, a heavy burden particularly among immunocompromised populations.

    Why it matters: First new-mechanism HSV drug approved by FDA in nearly three decades addresses unmet need in treatment-refractory patients.

Oct 10Sat
  1. WeChat73

    FDA Approves Teva's WELTRUZA, First Monthly Subcutaneous Long-Acting Olanzapine for Schizophrenia

    The FDA approved Teva's WELTRUZA (olanzapine extended-release injectable suspension) on October 9, 2026 for adults with schizophrenia. It is the first once-monthly subcutaneous long-acting olanzapine approved worldwide, and unlike earlier long-acting olanzapine injections it requires no routine 3-hour post-injection observation and no supplemental oral olanzapine at treatment start.

    Why it matters: First-approved monthly subcutaneous long-acting olanzapine removes monitoring and oral-loading burdens for schizophrenia patients.

  2. Reddit65

    US FDA approves Asahi Kasei's drug for persistent herpes infections

    The FDA approved Asahi Kasei's pritelivir (Hovilpri), a helicase-primase inhibitor, on 2026-10-09 for refractory HSV mucosal infections in immunocompromised adults, making it the first HSV drug with a new mechanism in nearly 30 years. Approval rests on the Phase 3 PRIOH-1 trial. Reddit users criticized accessibility, with one estimating roughly $26,667 per person for a 42-day course based on projected revenue of $400 million across 15,000 immunocompromised patients; no official price was given.

    Why it matters: First new-mechanism HSV drug approval in nearly 30 years, with community-disputed cost estimates.

  3. U.S. FDA87

    FDA Approves Drug to Treat Lesions Caused by Herpes Simplex Virus

    FDA has approved Hovilpri (pritelivir) tablets for mucocutaneous herpes simplex virus lesions in immunocompromised adults who did not respond to acyclovir, valacyclovir, or famciclovir.

    Why it matters: The source gives a 28-day healing rate of 63% versus 34% in the comparator group, letting readers gauge the benefit in this refractory population.

Oct 9Fri
  1. WeChat70

    FDA Approves AbbVie's D1/D5 Receptor Partial Agonist Juvmo for Adult Parkinson's Disease

    The FDA has approved AbbVie's D1/D5 receptor partial agonist Juvmo (tavapadon) for the treatment of Parkinson's disease in adults. The approval adds a new option that works by selectively modulating D1/D5 receptors, a subclass of dopamine receptors identified as a potential Parkinson's target more than 30 years ago, though progress on the approach had been slow. Juvmo becomes a newly approved choice for adult patients.

    Why it matters: First FDA approval of a D1/D5-selective mechanism in a target area stalled for over 30 years.

  2. 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.

  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. BioSpace62

    Newron reveals 5 deaths in late-stage schizophrenia program as FDA maintains hold

    Four deaths have occurred among patients receiving Newron's evenamide across all clinical studies, a 0.56% incidence, versus one death on placebo (0.27%); investigators deem three unrelated and one possibly related. The FDA's hold on the Phase 3 ENIGMA-TRS 2 trial in adjunctive schizophrenia therapy remains in place over concerns that evenamide, a selective voltage-gated sodium channel blocker, may cause irregular heartbeats. Newron reports no pattern of cardiac abnormalities in more than 5,000 ECGs from over 700 patients and is weighing added cardiac screening.

    Why it matters: The FDA hold on a late-stage schizophrenia program persists as total death counts across the development program surface.

  3. 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.

  4. 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.

  5. BioPharma Dive40

    Halozyme prevails in patent fight with Merck; Enliven readies anticipated leukemia trial

    A Netherlands court blocked sales of Merck's subcutaneous Keytruda Qlex in eight European countries, siding with Halozyme in a patent dispute over its under-the-skin drug delivery technology. Separately, Enliven Therapeutics reached agreement with the FDA on a late-stage trial of relcobitinib in chronic myeloid leukemia, enrolling 450 people to test superiority at spurring a major molecular response. Halozyme is also challenging Merck in a U.S. court after a win in Germany.

    Why it matters: Patent ruling blocks subcutaneous Keytruda across Europe and FDA-aligned CML trial design sharpens competition for Novartis and Merck.

Oct 7Wed
  1. BioSpace71

    Cerevance Parkinson’s drug shortens 'off time' in Ph. 3, paving path to FDA

    Solengepras shortened daily "off time" in a Phase 3 trial, positioning Cerevance to discuss an FDA approval path for the Parkinson's therapy. In 341 patients with motor fluctuations on levodopa, 150 mg of solengepras as adjunct treatment cut average daily off time by 1.56 hours from a baseline of 5.65 hours, versus a 0.95-hour drop with placebo, a 0.61-hour placebo-adjusted benefit at week 12 that appeared by week two. On time without dyskinesia also improved, with no serious adverse events in the high-dose group.

    Why it matters: Positive Phase 3 data for a non-dopaminergic Parkinson's adjunct advance a potential FDA filing in a field with few recent wins.

  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.

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