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Mar 02, 2026
Oncolytics Biotech launches Phase 2 trial of pelareorep immunotherapy in metastatic colorectal cancer, following Fast Track Designation and promising earlier results showing 27-month median survival.
Mar 02, 2026
uniQure received FDA feedback stating current AMT-130 data unlikely to support accelerated approval for Huntington's disease, while securities fraud lawsuits challenge prior disclosures. Fresh Fabry disease trial data showed elevated enzyme activity but prompted a dosing pause for safety review.
Mar 02, 2026
The FDA has accepted the New Drug Application for rusfertide, a first-in-class hepcidin mimetic peptide for polycythemia vera, and granted Priority Review with a PDUFA goal date in the third quarter of 2026.
Mar 02, 2026
The FDA has accepted Regeneron's biologics license application for garetosmab with priority review, targeting fibrodysplasia ossificans progressiva. A decision is expected by August 2026 based on Phase 3 trial data showing significant reductions in new bone lesions.
Mar 02, 2026
The FDA has accepted Savara's Biologics License Application for Molbreevi in autoimmune pulmonary alveolar proteinosis, granted priority review, and set a PDUFA action date of August 22, 2026. The company plans to file marketing authorization applications in the EU and UK by the end of March.
Mar 02, 2026
Samsung Bioepis reached settlement agreements with Regeneron and Bayer for its aflibercept biosimilar OPUVIZ, enabling U.S. launch in January 2027 and staged international rollout beginning early 2026.
Mar 02, 2026
Moderna's mRNA-1010 seasonal influenza vaccine enters FDA review following a revised approach that splits approval pathways by age group, with a decision expected by August 2026.
Mar 02, 2026
Australian regulators confirmed counterfeit GLP-1 products contain no active ingredients, while U.S. authorities escalate enforcement against compounded weight-loss drugs as Novo Nordisk sues telehealth company Hims & Hers.
Mar 01, 2026
Corcept Therapeutics received an FDA Complete Response Letter denying approval of relacorilant for hypertension secondary to hypercortisolism, triggering a 44.76% stock decline and multiple securities class actions.
Mar 01, 2026
Bristol Myers Squibb and SystImmune reported that antibody-drug conjugate izalontamab brengitecan achieved statistically significant improvements in both progression-free and overall survival versus chemotherapy in a Phase III trial for triple-negative breast cancer.
Mar 01, 2026
Aardvark Therapeutics has voluntarily paused its Phase 3 HERO trial testing ARD-101 for hyperphagia in Prader-Willi Syndrome patients after reversible cardiac observations were identified during safety monitoring, delaying expected topline data beyond Q3 2026.
Mar 01, 2026
Teva and Sanofi reported durable 44-week efficacy for duvakitug in inflammatory bowel disease, while the FDA accepted Teva's application for TEV-749, a once-monthly olanzapine injection for schizophrenia.
Feb 28, 2026
The FDA approved pembrolizumab in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1).
Feb 28, 2026
The FDA has granted breakthrough device designation to two rapid diagnostic assays from NG Biotech and Hardy Diagnostics targeting Candida auris and carbapenem-resistant Acinetobacter baumannii, both identified as global health priorities by the WHO.
Mar 01, 2026
Inovio Pharmaceuticals trades as a speculative micro-cap biotech on NASDAQ, with DNA medicine candidates in oncology and infectious disease facing binary clinical risks and ongoing capital needs.
Mar 01, 2026
Amgen, Celltrion, and Palatin Technologies are advancing obesity drug candidates through clinical development, with trials planned for 2026-2028 targeting liver fat reduction, multiple biological pathways, and rare genetic obesity conditions.
Mar 01, 2026
Cogent Biosciences presented additional SUMMIT trial data showing bezuclastinib achieved 56% improvement in symptoms at 48 weeks in NonAdvSM patients, with multiple regulatory submissions advancing toward expected commercial launch in second half of 2026.
Feb 28, 2026
Next-generation in vivo CAR-T therapy enables cancer treatment with a single injection, while new Texas legislation and community-based delivery models expand patient access to this advanced cellular therapy.
Feb 28, 2026
The FDA has granted accelerated approval for YUVIWEL (navepegritide), the first once-weekly treatment for children with achondroplasia. Commercial availability is expected in early Q2 2026, with a Rare Pediatric Disease Priority Review Voucher granted.
Feb 28, 2026
NRx Pharmaceuticals completed an in-person FDA Type C meeting regarding NRX-100, a preservative-free ketamine formulation for suicidal depression. The company received guidance on a path to file a New Drug Application based on existing trial data and Real World Evidence from over 65,000 patients.
