The FDA on Friday alerted healthcare providers and the public that it’s seeing reports of unintended overdoses of the compounded version of self-injected weight loss drug semaglutide, which can be manufactured by facilities that aren’t directly regulated by the federal agency. The FDA cited several cases in which healthcare providers incorrectly calculated...

Pharma has a message to investors about the results of the first round of drug price negotiations under the Inflation Reduction Act: It’s fine. Over the last two weeks, many of the drugmakers subject to IRA pricing have, for the first time, said what they think of the prices they’ve ended up with after negotiations with the Centers for Medicare &...

Pfizer and BioNTech have called GSK’s patent lawsuit “groundless,” accusing the British drugmaker of “improperly contorting” its claims to say their blockbuster Covid vaccine is covered by GSK patents. GSK in April filed suit against Pfizer and BioNTech, alleging the companies benefited from mRNA research conducted years before the pandemic. GSK said...

Bristol Myers Squibb has resumed recruitment for its lead radiopharmaceutical trial after an isotope shortage forced a pause earlier this year, chief medical officer Samit Hirawat said on the company’s second-quarter earnings call. While the large pharma has resumed the Phase 3 study from its $4.1 billion RayzeBio buyout, it has now delayed the Phase...

For years, Andrew Left and his short-selling fund Citron Research were a swashbuckling presence on social media, accusing companies of fraud and misdeeds, and making stock bets that he was right. On Friday, the Securities and Exchange Commission accused Left and Citron of fraud themselves, saying they misled investors with stock recommendations to...

To extend its cash reserves, Cue Biopharma is shifting focus away from its oncology assets and will zero in on its autoimmune disease pipeline instead. The biotech is also slashing its workforce by 25%. Its preclinical autoimmune pipeline features the Ono Pharmaceutical-partnered CUE-401, which is designed to increase the number of regulatory immune...