Biotech

Sanofi SA (NASDAQ:SNY) on Tuesday agreed to acquire Vicebio Ltd, a privately held biotechnology company headquartered in London, U.K. The acquisition brings an early-stage combination vaccine candidate for respiratory syncytial virus (RSV) and human metapneumovirus (hMPV), both respiratory viruses...

The U.S. Food and Drug Administration appointed George F. Tidmarsh on Monday as director of the Center for Drug Evaluation and Research (CDER). Tidmarsh earned his M.D. and Ph.D. in cancer biology from Stanford University, where he completed residency training in pediatrics. He completed two...

According to a new U.S. Congressional Budget Office analysis, President Donald Trump’s 2026 budget plan proposes cuts to the National Institutes of Health that could significantly reduce the number of new drugs entering the market. The agency projected that slashing NIH funding by billions...

Replimune Group, Inc. (NASDAQ:REPL) stock plunged on Tuesday after a U.S. Food and Drug Administration (FDA) update. The clinical stage biotechnology company received an FDA Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in...

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) announced Monday it will voluntarily and temporarily pause all U.S. shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, effective July 22. This reversal follows Sarepta's initial refusal to halt distribution despite a Food and Drug...

On Monday, AstraZeneca Plc (NASDAQ:AZN) released high-level results from the final overall survival (OS) analysis of the FLAURA2 Phase 3 trial of Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy. The study demonstrated a statistically significant and clinically...

On Friday, the U.S. Food and Drug Administration placed Sarepta Therapeutics Inc.’s (NASDAQ:SRPT) investigational gene therapy clinical trials for limb girdle muscular dystrophy (LGMD) on a clinical hold. The decision stemmed from serious safety concerns, including three patient deaths...

Biogen Inc. (NASDAQ:BIIB) said on Monday that it plans to invest an additional $2 billion in its existing manufacturing footprint in North Carolina’s Research Triangle Park (RTP). Biogen has invested approximately $10 billion in its North Carolina manufacturing footprint to date,...

Alkermes plc (NASDAQ:ALKS) on Monday released topline results from the randomized double-blind treatment period of the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1). Narcolepsy is a chronic neurological disorder that disrupts the body’s ability to...

In a recent social media post, Peter Ray, senior director of medicinal chemistry at Recursion Pharmaceuticals, Inc. (NASDAQ:RXRX), drew attention to a new article in WIRED from Veronique Greenwood (vero_greenwood). This article highlighted REC-3565, an investigational drug candidate. Greenwood...

The ground shook for Sarepta Therapeutics, Inc. (NASDAQ:SRPT) last week as the U.S. Food and Drug Administration (FDA), alarmed by a third patient death tied to its gene therapy platform, pulled a rare move: requesting a voluntary halt to Elevidys shipments. The company’s response? A...

As the pharmaceutical industry increasingly focuses on developing targeted treatments for niche conditions, Viatris Inc. (NASDAQ:VTRS) on Friday announced topline data from a Phase 3 study evaluating the efficacy and safety of pimecrolimus 0.3% (MR-139) ophthalmic ointment in subjects with...

Bristol Myers Squibb & Co. (NYSE:BMY) on Friday announced topline results from the Phase 3 INDEPENDENCE trial evaluating Reblozyl (luspatercept-aamt) with concomitant janus kinase inhibitor (JAKi) therapy in adult patients with myelofibrosis-associated anemia receiving red blood cell (RBC)...

MEI Pharma, Inc. (NASDAQ:MEIP) stock is trading higher on Friday, with a session volume of 35.64 million compared to the average volume of 29.8K, as per data from Benzinga Pro. The company on Friday entered into a private investment in public equity (PIPE) for the purchase and sale of 29.2 million...

Sarepta Therapeutics (NASDAQ:SRPT) shares plummeted on Friday following reports of a third patient death linked to its gene therapy pipeline this year, further clouding investor confidence despite the company’s recent efforts to provide clarity on its restructuring and FDA label plans. The...