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Feb 13, 2026
Multiple law firms have filed securities fraud class actions against uniQure N.V. after the FDA reversed its position on the company's AMT-130 Huntington's disease drug candidate, causing shares to plummet 49% in a single day.
Feb 13, 2026
The FDA will review Moderna's mRNA-1010 seasonal influenza vaccine after the company proposed a revised regulatory pathway, setting an August 2026 decision date following an earlier refusal-to-file letter.
Feb 13, 2026
The FDA approved Optune Pax, a wearable Tumor Treating Fields device, for locally advanced pancreatic cancer in combination with gemcitabine and nab-paclitaxel. The approval marks the first new treatment for this indication in nearly 30 years.
Feb 13, 2026
Samsung Bioepis and Regeneron reached a settlement allowing U.S. launch of Opuviz, an aflibercept biosimilar, in January 2027. The agreement resolves a patent dispute that began in late 2023.
Feb 13, 2026
Congress enacted legislation narrowing orphan drug exclusivity to specific approved uses rather than entire diseases, overriding an 11th Circuit ruling and aligning the statute with FDA's traditional approach.
Feb 13, 2026
The U.S. FDA granted orphan drug designation to HCB101, a next-generation immunotherapy from HanchorBio, for treating gastric cancer including HER2-positive and HER2-negative subtypes.
Dec 29, 2025
Artificial intelligence emerged as the dominant topic in clinical research during 2025, with applications spanning operational efficiency, drug discovery, and patient recruitment, though no AI-discovered drug has yet achieved FDA marketing approval.
May 03, 2025
The FDA accepted Takeda's NDA for oveporexton (TAK-861), an oral orexin receptor 2 agonist for narcolepsy type 1, and granted Priority Review with a PDUFA goal date in Q3 2026. The drug could become the first approved orexin agonist.
Dec 30, 2025
Drug Hunter's most-accessed resources, reviews, and case studies in 2025 reflected key trends in drug discovery, including the rise of oral macrocycles, advances in new modalities, and the shift from biologics to small molecules in immunology.
May 01, 2025
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.
Sep 11, 2025
The FDA issued a Complete Response Letter for Corcept's relacorilant as a treatment for hypertension secondary to hypercortisolism, requesting additional evidence of effectiveness despite acknowledging positive trial results.
Dec 11, 2025
Amgen received FDA and European Commission approval for Uplizna to treat generalized myasthenia gravis in adults who are anti-AChR or anti-MuSK antibody positive, offering twice-yearly maintenance dosing after initial loading doses.
Dec 18, 2025
The FDA approved a once-monthly dosing schedule for Rybrevant Faspro with Lazcluze for first-line treatment of EGFR-mutated advanced NSCLC, reducing clinic visits while maintaining safety and efficacy established with bi-weekly dosing.
Oct 01, 2025
The FDA approved Zycubo (copper histidinate) on January 13, 2026, as the first treatment for Menkes disease in pediatric patients, following resolution of manufacturing compliance concerns that led to an initial rejection in September 2025.
Jan 16, 2026
The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen, for cancer patients at risk of infection due to chemotherapy and other indications. The approval marks Accord BioPharma's sixth biosimilar product.
Feb 12, 2026
The FDA approved pembrolizumab (Keytruda) and Keytruda Qlex plus paclitaxel, with or without bevacizumab, for adults with PD-L1+ platinum-resistant ovarian carcinoma based on Phase 3 trial data showing improved survival outcomes.
Dec 12, 2025
Eli Lilly reported positive Phase 3 results for retatrutide showing up to 71.2 lbs average weight loss, while stockpiling $1.5 billion of oral drug orforglipron ahead of anticipated FDA approval in April 2026.
Jan 29, 2026
The FDA placed clinical holds on Regenxbio's RGX-111 and RGX-121 gene therapies following a tumor case in an MPS I patient. The company's stock fell nearly 18% on the news.
Dec 19, 2025
Eli Lilly has built $1.5 billion in pre-launch inventory of oral weight loss drug orforglipron ahead of an April 2026 FDA decision, while Phase 3 data showed the drug maintained weight loss after switching from injectables.
Feb 11, 2026
The FDA announced a full reassessment of butylated hydroxyanisole (BHA), a chemical preservative used in packaged foods, to determine if it remains safe based on current science. The review follows decades of concerns about BHA being listed as "reasonably anticipated to be a human carcinogen."
