The European Medicines Agency has recommended authorizing a twice-yearly injectable drug to prevent HIV. Scientists say this ...

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

Eli Lilly has cleared a major hurdle in its bid to win European approval for its Alzheimer's disease drug Kisunla.

Two teenage boys who took the gene therapy died of acute liver failure, and a third liver failure death last month came after a 51-year-old patient took another Sarepta gene therapy to treat a ...

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.

NANJING, China, July 25, 2025 /PRNewswire/ -- On 25 July, 2025 (China Time), Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" ...

Arquitos Capital Management gained 13.1% in Q2 2025. Learn how they turned market uncertainty into opportunity with Liquidia ...

Restructuring pipeline to focus on AAV cardiovascular platform (Danon disease, PKP2-ACM, BAG3-DCM) and regulatory activities for KRESLADI™ (severe LAD-I), ...

Israeli food tech firm Believer Meats has secured US FDA approval for its cultivated meat, and completed the construction of ...

China's Sciwind Biosciences is in talks with a U.S. company interested in licensing its experimental weight-loss drug for ...

A dozen lawsuits have been filed over spinal cord stimulators, which are medical devices surgically implanted to reduce chronic back pain. The suits name device manufacturers, such as Abbott and ...