FDA officials from CDER say the agency is prepared to approve psychedelic therapies for chronic psychiatric disorders based on 12-week efficacy data, before sponsors have settled how long effects last or when patients need redosing. The position appears in a New England Journal of Medicine article and clarifies what the agency's final guidance for psychedelic drug development, released in July, left open. Companies profiled include Compass Pathways, Cybin, Ataibeckly and Eli Lilly.
The FDA has approved Moderna's mRNA seasonal influenza vaccine mFlusiva for people aged 50-64. It is the first seasonal flu vaccine to use mRNA-based production, encoding full-length hemagglutinin from three WHO-recommended strains in lipid nanoparticles, allowing rapid updates to match circulating strains. In two clinical trials, mFlusiva outperformed GlaxoSmithKline's four-strain vaccine Fluarix in preventing infection or eliciting antibody responses.
Scholar Rock's injectable monoclonal antibody has received FDA approval, making it the first therapy to treat muscle atrophy in patients with spinal muscular atrophy (SMA).
Takeda said the FDA has accepted for priority review its new drug application for zasocitinib (TAK-279), an oral TYK2 inhibitor in development for adults with moderate to severe plaque psoriasis. Takeda acquired the drug from Nimbus Therapeutics in 2022 for $4 billion upfront and up to $6 billion in total. A regulatory decision from the FDA is the next step.
Novo Nordisk won Chinese approval on September 10, 2026 for semaglutide injection (Wegovy) in metabolic dysfunction-associated steatohepatitis (MASH), covering non-cirrhotic adults with moderate to severe fibrosis (stage F2-F3). It is the first drug approved for MASH in China and the only GLP-1 drug with this indication. MASLD affects about 38% of adults worldwide.
GSK is preparing to submit a first-line FDA application for Jideytro, its first lung cancer drug. The filing is supported by data showing an unprecedented complete response rate. Jideytro is positioned as GSK's first lung cancer asset.
On August 11, 2026, China's NMPA approved trastuzumab deruxtecan (T-DXd) combined with pertuzumab for first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. The approval rests on the global DESTINY-Breast09 trial, which showed efficacy exceeding standard treatment with a safety profile validated in clinical testing. Professor Liao Ning offers a comprehensive assessment of the regimen, citing durable survival and manageable safety.
The FDA has approved Scholar Rock's Isembyld, the first therapy to target muscle loss in spinal muscular atrophy, for adults and children aged 2 and older already receiving SMA therapies that target SMN2. In a late-stage trial, Isembyld combined with an SMN2-targeting drug improved young patients' motor skills over a year while placebo recipients declined, a statistically significant difference. Approval was granted on Friday.
Novo Nordisk's semaglutide injection (Wegovy/Novo Nordisk's brand Nuvo Ying) has been approved for MASH in patients with moderate to severe liver fibrosis. The approval is based on the primary results of part 1 of the ESSENCE outcomes trial, which enrolled 1,197 MASH patients with biopsy-confirmed F2 or F3 fibrosis. Semaglutide met both liver histology primary endpoints versus placebo.
Labcorp will offer Roche Diagnostics' Elecsys pTau-217 blood test in the US, the first and only FDA-approved single-biomarker blood test for Alzheimer's-related amyloid pathology. It measures pTau-217 in blood to help clinicians identify or rule out Alzheimer's-related pathology in people aged 55 and older with cognitive decline or related symptoms, in both general and specialty care settings.
The FDA has accepted Intellia Therapeutics' BLA for lonvoguran ziclumeran (lonvo-z), an in vivo CRISPR therapy for hereditary angioedema, with priority review and a PDUFA goal date of March 10, 2027. The agency does not plan to convene an advisory committee. If approved, lonvo-z would be the first approved in vivo CRISPR therapy and the only single-treatment option for HAE.
Novo Nordisk's semaglutide injection, Wegovy, has been approved in China for metabolic dysfunction-associated steatohepatitis (MASH), the first and only approval for this indication there. The decision rests on primary results from part 1 of the ESSENCE outcomes trial in semaglutide-treated MASH patients with moderate to severe hepatic fibrosis, which enrolled 1,197 patients with biopsy-confirmed MASH and F2 or F3 stage fibrosis. The approval extends the product's evidence base from weight management and cardiovascular health into liver health.
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.
The FDA has approved Moderna's mFlusiva, an mRNA-based seasonal flu vaccine, for people aged 50–64. It is the first seasonal influenza vaccine to use mRNA production, encoding full-length hemagglutinin from three WHO-recommended strains delivered in lipid nanoparticles. In two clinical trials, mFlusiva outperformed GlaxoSmithKline's four-strain vaccine Fluarix in preventing influenza infection or eliciting antibody responses.
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).
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.
AstraZeneca's camizestrant, combined with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), received FDA accelerated approval on September 4 for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer who developed ESR1 mutations during aromatase inhibitor and CDK4/6 inhibitor treatment. The FDA also approved a companion diagnostic that detects emerging ESR1 resistance mutations in circulating tumor DNA. The approval rests on the pivotal Phase III SERENA-6 trial.
Why it matters: FDA accelerated approval of AstraZeneca's camizestrant plus CDK4/6 inhibition for ESR1-mutant breast cancer, with a ctDNA companion diagnostic.
Japan enacted the Act on Regulation of Handling of Human Genome-Edited Embryos, etc. on 17 July 2026, promulgated a week later as Act No. 70 of 2026, criminalizing the reproductive use of genome-edited human embryos. The law replaces non-binding 2019 guidelines that barred transfer of edited embryos to a uterus without penalty, and closes a gap left by the 2000 Act on Regulation of Human Cloning Techniques, which did not cover genome-edited embryos. Tsutomu Sawai of Hiroshima University notes that a national criminal ban can still be evaded by seeking the procedure abroad.
Why it matters: Japan converts non-binding guidance into criminal law on heritable genome editing, a regulatory shift relevant to reproductive medicine.
The FDA approved Priovant Therapeutics' Lisraya (brepocitinib), a first-in-class selective dual TYK2/JAK1 inhibitor, for adult dermatomyositis on August 27, 2026. Priovant was set up by Roivant and Pfizer, and the drug, originally coded PF-06700841, was discovered and taken through early-phase I/II trials by Pfizer. It is the only approved targeted oral therapy for dermatomyositis, received orphan drug designation and priority review, and is now available in the US.