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Mar 08, 2026
Novartis announced positive European regulatory opinion for remibrutinib in chronic spontaneous urticaria and reported the drug met its primary endpoint in a Phase 3 trial for chronic inducible urticaria.
Mar 08, 2026
C4 Therapeutics has initiated its Phase 2 MOMENTUM trial of cemsidomide in relapsed/refractory multiple myeloma, targeting enrollment completion in Q1 2027 and a registrational dataset by 2028. The company plans a combination study with elranatamab in Q2 2026.
Mar 07, 2026
Dr. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, will depart the agency by the end of April to return to an academic role at the University of California San Francisco.
Mar 07, 2026
Incyte received a Complete Response Letter from the FDA for Zynyz in lung cancer due to third-party manufacturing issues, while the EMA recommended approval for the drug in anal cancer treatment based on Phase 3 trial data.
Mar 07, 2026
The FDA has denied or discouraged at least eight drug applications in the past year, including treatments for rare diseases, raising concerns about regulatory consistency and the future of experimental therapies.
Mar 06, 2026
Dyne Therapeutics is preparing a U.S. Accelerated Approval submission for z-rostudirsen in Duchenne muscular dystrophy and gearing up for a Phase 3 trial of z-basivarsen in myotonic dystrophy, while scaling operations to support potential commercialization.
Mar 05, 2026
Protagonist Therapeutics reported fourth quarter and full year 2025 financial results, with two NDAs submitted and multiple Phase 3 trials advancing. The company holds $646 million in cash and expects regulatory decisions in 2026.
Mar 06, 2026
Outlook Therapeutics conducted a Type A meeting with the FDA to discuss the December 30, 2025 Complete Response Letter for ONS-5010/LYTENAVA™, focusing on substantial evidence of effectiveness and potential regulatory paths forward.
Mar 06, 2026
New clinical trials show single doses of psilocybin and LSD produce significant, lasting reductions in OCD and generalized anxiety disorder symptoms for up to 12 weeks, marking a potential shift from daily medication regimens.
Mar 06, 2026
The FDA has accepted Hansa Biopharma's Biologics License Application for imlifidase, a desensitization treatment for highly sensitized adult kidney transplant patients with positive crossmatch against deceased donors, with a PDUFA date of December 19, 2026.
Mar 06, 2026
Roche announced positive phase II results for obesity drug petrelintide showing 10.7% weight reduction, while the FDA set a December 18 decision date for breast cancer drug giredestrant.
Mar 06, 2026
The FDA approved Tecvayli plus Darzalex Faspro for relapsed or refractory multiple myeloma after at least one prior therapy, and accepted a new drug application for iberdomide plus daratumumab and dexamethasone with a PDUFA date of August 17, 2026.
Mar 06, 2026
Two gene therapies for inherited eye diseases have progressed to clinical trials, with the FDA clearing Sanaregen's SVT-001 for Familial Drusen and SpliceBio treating its first patient in a Stargardt disease trial in Oxford.
Mar 06, 2026
Pfizer reported positive Phase 3 trial results for BRAFTOVI combination therapy in metastatic colorectal cancer and received FDA Priority Review for HYMPAVZI expansion to hemophilia patients including children.
Mar 06, 2026
The FDA has placed a partial hold on U.S. enrollment in a Phase 2 trial of del-desiran for myotonic dystrophy type 1, citing preclinical mouse data showing blood pressure drops not seen in humans, following a serious adverse event in earlier testing.
Mar 05, 2026
Altimmune's pemvidutide received FDA Breakthrough Therapy Designation for MASH treatment, with Phase 3 trial initiation planned for 2026. The company raised $75 million in January 2026 to fund development.
Mar 05, 2026
New treatments for rare pediatric neurological conditions show promise, with zorevunersen reducing seizures in Dravet syndrome patients and an SMA therapy under FDA review following stem cell research breakthroughs.
Mar 05, 2026
The global biosimilar market is experiencing robust growth, valued at USD 36.79 billion in 2024 and projected to reach USD 282.3 billion by 2035 at a CAGR of 20.35%, driven by patent expirations, cost pressures, and expanding access to biologic therapies.
Mar 05, 2026
The FDA has placed a partial clinical hold on PepGen's Phase 2 FREEDOM2-DM1 trial for myotonic dystrophy type 1, citing questions about preclinical pharmacology and toxicology studies. The company is submitting additional analyses to address the FDA's concerns.
Mar 05, 2026
Medicus Pharma reported Phase 2 SKNJCT-003 topline data showing 73% clinical clearance and 40% histological clearance at Day 57 in the 200μg cohort. Separately, the FDA cleared the company to begin a Phase 2b dose optimization study for Teverelix in advanced prostate cancer.
