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FDA

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

264 picksRelatedEMA / CHMPNMPA / CDERegulatory

Latest picks

21–40 of 264
Oct 16Fri
  1. WeChat66

    Broad-Spectrum RAS Inhibitor Daraxonrasib Wins FDA Approval in Metastatic Pancreatic Cancer

    The broad-spectrum RAS inhibitor daraxonrasib received FDA approval on August 26 for metastatic pancreatic cancer in adults who have received at least one prior systemic therapy or are not suitable for multi-drug combination systemic therapy. Unlike KRAS G12C inhibitors, it covers mutations including G12V, G12D, G13 and Q61, and the article also notes strong efficacy in lung cancer.

    Why it matters: First approval extending RAS inhibition beyond KRAS G12C to multiple RAS mutations in pancreatic cancer.

  2. WeChat70

    Cerevance Parkinson's Drug Solengepras Hits Primary Endpoint in Phase III

    Cerevance announced that the Phase III ARISE trial of solengepras (CVN424) met its primary endpoint, with the 150 mg group showing a reduction of 0.61 hours in mean daily OFF time versus placebo at week 12. The drug is a selective inverse agonist targeting GPR6 through a non-dopaminergic mechanism, and the company plans to discuss the path to a marketing application with the FDA.

    Why it matters: The 0.61-hour OFF-time reduction and motor function improvement let readers compare effect size with existing Parkinson's adjunctive therapies.

  3. U.S. FDA56

    Navigating the FDA Bayesian Draft Guidance: Design, Analysis, and Review Considerations - 10/14/2026

    FDA's CDER Small Business and Industry Assistance unit will host a free virtual webinar on October 14, 2026, 12:00-1:00 p.m. ET, on the January 2026 draft guidance "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products," which addresses a PDUFA VII commitment. Speakers include John Scott of CBER and CDER statisticians James Travis and Van Tran, covering success criteria, operating characteristics, prior distributions, estimands, missing data, software and reporting expectations. The guidance is aimed at trial, regulatory science and regulatory affairs professionals, with Bayesian methods most relevant to pediatric and rare disease trials.

    Why it matters: FDA staff will explain how to apply the new Bayesian draft guidance to trial design and regulatory review.

Oct 15Thu
  1. BioSpace62

    FDA's latest rare disease framework seeks to prioritize consistency in flexibility

    The FDA launched its Rare Disease Framework Initiative to standardize how clinical trial requirements are applied across rare diseases while tailoring evidence expectations to what small patient populations can realistically generate. Only 5% of an estimated 10,000 rare conditions affecting 30 million Americans have an FDA-approved treatment. The framework builds on programs such as the Rare Disease Innovation Hub, CDER's ARC program and the RDEA pilot, and follows the November 2025 plausible mechanism pathway. The FDA will hold a meeting on Oct. 28 to gather feedback from patients, advocates and industry.

    Why it matters: FDA policy shift sets consistent rules for rare disease drug development, a core issue for sponsors of gene and cell therapies.

  2. 监管与产业动态52

    FDA clears ImmunityBio’s Anktiva expansion in bladder cancer after regulatory whiplash - Fierce Pharma

    The FDA has approved an expanded indication for ImmunityBio's Anktiva in bladder cancer, ending earlier regulatory setbacks. The source material contains only the headline; the approval scope, trial data and timeline are not given in the current materials.

    Why it matters: Hot story: reported by four sources covering the same event.

  3. Reddit65

    FDA approves once-daily Parkinson’s pill (Juvmo) built on decades of work by husband-and-wife team

    The FDA approved Juvmo (tavapadon, NDA 220415) on 28 September 2026 as the first selective D1/D5 dopamine receptor agonist, a once-daily oral pill for Parkinson's disease. Support came from the TEMPO-1/2/3 phase 3 trials, which showed monotherapy improved MDS-UPDRS scores and, combined with levodopa, increased "on" time by about 1.7 hours versus 0.6 hours for placebo. US availability is expected in October 2026; superiority over levodopa has not been shown.

    Why it matters: First selective D1/D5 dopamine agonist approval gives clinicians a new Parkinson's mechanism option.

  4. U.S. FDA63

    Rare Disease Framework

    The FDA, with the Reagan-Udall Foundation for the FDA, will hold a hybrid public meeting on October 28, 2026, to gather input on its Rare Disease Framework Initiative, which aims to reimagine the agency's approach to rare disease drug development and review. The framework would tailor regulatory advice and decision-making to the evidence reasonably attainable for each disease, embed the patient voice at defined milestones, leverage external expertise, and apply risk-based approaches to manufacturing review and inspections. Changes could come through regulations, guidance documents and internal processes; FDA set out its aims in a white paper released October 14, 2026.

    Why it matters: FDA's rare disease development and review overhaul could change regulatory expectations for sponsors of orphan drugs.

Oct 14Wed
  1. U.S. FDA91

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

    The FDA has expanded approval of Anktiva (nogapendekin alfa inbakicept-pmln), given with BCG, to cover adults with BCG-unresponsive, high-grade papillary non-muscle invasive bladder cancer (NMIBC). It is the first approved treatment for this subtype.

    Why it matters: The source reports complete response rates and 12- and 24-month durability figures, and explains how FDA extrapolated CIS data to the high-grade papillary subtype.

  2. WeChat74

    FDA Approves Teva's WELTRUZA, a Once-Monthly Subcutaneous Olanzapine for Schizophrenia

    The US FDA has approved Teva's WELTRUZA (olanzapine) extended-release injectable suspension for treating adults with schizophrenia. It is the first and currently only olanzapine long-acting injectable given as a once-monthly subcutaneous injection for that indication, requiring no loading dose, no oral supplementation and no post-injection monitoring. The approval rests on the pivotal SOLARIS study.

    Why it matters: First FDA-approved once-monthly subcutaneous olanzapine long-acting injectable for schizophrenia.

  3. WeChat67

    NMPA and FDA Approve Pirtobrutinib for First-Line CLL/SLL Treatment

    China's NMPA approved pirtobrutinib on September 28, 2026 for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) across all lines, including those untreated. On October 2, 2026, the FDA followed with approval for previously untreated adults with CLL/SLL and no known 17p deletion. Pirtobrutinib is a highly selective, non-covalent (reversible) BTK inhibitor that inhibits both wild-type BTK and BTK carrying the C481 mutation without forming a covalent bond at C481.

    Why it matters: Two major regulators approved pirtobrutinib for first-line CLL/SLL within days of each other.

  4. JAMA Network71

    FDA Approves 2 New Alzheimer Disease Blood Tests

    The FDA has approved two new blood tests to detect Alzheimer disease in adults with cognitive symptoms, one of which is indicated for people as young as 40. The source is an RSS summary only; product names and further details of the two tests are not provided.

    Why it matters: Two Alzheimer blood tests were approved, one for people as young as 40, a useful comparison with the indicated populations of earlier blood tests.

Oct 13Tue
  1. WeChat73

    FDA approves Asahi Kasei's oral HSV drug Hovilpri (pritelivir), first new-mechanism HSV drug in nearly 30 years

    The US FDA has approved Hovilpri (pritelivir), an oral herpes simplex virus (HSV) drug from Japan's Asahi Kasei, as the first HSV treatment with a new mechanism of action approved in nearly 30 years. The drug is the core asset from Asahi Kasei's $920 million acquisition of German biotech Aicuris in April 2026.

    Why it matters: First new-mechanism HSV approval in nearly 30 years, from a recent $920 million acquisition.

  3. Nature80

    FDA nod for rare neurology drug

    The FDA has approved Ionis Pharmaceuticals' Zanvastro (zilganersen), the first disease-modifying drug for Alexander disease, a rare progressive and often fatal neurological condition affecting about one person per 1-3 million. The antisense oligonucleotide targets RNA encoding glial fibrillary acidic protein (GFAP), reducing its overproduction in astrocytes, where excess GFAP forms clumps that disrupt myelination. Patients suffer impaired motor function, seizures, intellectual disability and developmental delays.

    Why it matters: First disease-modifying therapy approved for a rare, previously untreatable neurological condition.

Oct 12Mon
  1. U.S. FDA73

    Hiding in Plain Sight: 7-OH Products

    DEA issued two new Notices of Intent on October 9, 2026, based on updated HHS analysis, proposing threshold-based Schedule I control for 7-hydroxymitragynine (7-OH) and mitragynine pseudoindoxyl (MGPI). HHS recommends Schedule I when either substance, or their combined amount, exceeds 1 milligram per gram in solids or 1 milligram per milliliter in liquids, or when the mitragynine ratio to them falls below 100 to 1. DEA will reissue its Notice of Intent without changing the current scheduling approach for MGM-15 and MGM-16, which were temporarily placed in Schedule I on August 26, 2026; controls stay in effect during the 30-day notice period and until a new temporary scheduling order.

    Why it matters: DEA sets quantitative thresholds that decide which kratom-derived opioid products fall under Schedule I control.

  2. BioSpace69

    RevMed's Rasonque gets a subtype data asterisk, but analysts remain bullish

    FDA review documents show that Revolution Medicines' RAS inhibitor Rasonque, approved early for pancreatic adenocarcinoma, performed unevenly across KRAS mutation subtypes in the Phase 3 RASolute 302 trial. Overall ORR was 33%, but patients with G12V mutations reached 50%, G12D patients 24%, and the small G12R cohort just 7%, below the chemotherapy control. Analysts at Leerink and Truist called the gap exploratory and still expect a record launch, with Truist projecting $2.3 billion in sales by 2028 if the drug moves into first-line disease.

    Why it matters: Subtype-level efficacy data on a newly approved RAS inhibitor may open competition in the KRAS G12D pancreatic cancer market.

  3. Reddit61

    FDA approves olanzapine monthly subQ LAI (Weltruza)

    The FDA approved Weltruza, a once-monthly subcutaneous olanzapine long-acting injectable, on 2026-10-09 for psychotic disorders. It was developed by Teva with Medincell's SteadyTeq technology and supported by the SOLARIS trial (NCT05693935). Unlike olanzapine's existing LAI, it requires no loading dose, oral overlap or post-injection monitoring; psychiatrists discussing it flagged cost and insurance coverage as open questions.

    Why it matters: Clinicians see it as an adherence-friendly alternative to current LAIs, with cost and sedation still unresolved.

  4. Pharmaceutical Technology70

    FDA approves Teva’s monthly injection of olanzapine for schizophrenia

    Teva announced FDA approval of Weltruza, a once-monthly subcutaneous long-acting injectable olanzapine for schizophrenia. Approval was based on Phase III SOLARIS trial data (NCT05693935). Weltruza uses Medincell copolymer sustained-release technology and comes in 318mg, 425mg and 531mg doses corresponding to oral 10mg, 15mg and 20mg, with no loading dose, oral supplementation or post-injection monitoring required. It launches in the US within weeks.

    Why it matters: Approved on Phase III SOLARIS data, monthly dosing without loading doses or post-injection monitoring offers an alternative for patients with poor long-term adherence.

  5. Pharmaceutical Technology81

    FDA approves Asahi Kasei’s Hovilpri for refractory HSV

    The US FDA has approved Asahi Kasei Therapeutics' Hovilpri (pritelivir) 100mg tablets for refractory mucocutaneous HSV lesions in immunocompromised adults who do not respond to standard antiviral treatments such as acyclovir, famciclovir, or valacyclovir.

    Why it matters: The article gives specific day-28 and day-42 complete healing and safety differences, and compares Hovilpri's helicase-primase mechanism with nucleoside analogues.

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