Thursday, the FDA addressed the shortfall with a label expansion for GSK’s Blujepa, which brings an oral option and a new ...

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people ...

FDA may expedite approval timeline for Eli Lilly's weight-loss treatment, potentially moving decision date to late March from ...

Leaders at the U.S. Food and Drug Administration have pressed internally for reviewers to speed up their evaluation of Eli ...

An anti-vaccine organization founded by HHS Secretary Robert F. Kennedy Jr. is urging the FDA he now oversees to pull the ...

"Considering the urgent global need for new gonorrhea treatments, the finding that a single-dose of oral zoliflodacin was efficacious at curing urogenital and rectal and pharyngeal gonorrhoea is ...

Conditional approval extended through December 2026 for the treatment of CID in dogs CID confirmatory effectiveness trial expected to conclude in February 2026, ahead of FDA’s June deadline – 51 dogs ...

In a closely watched case, the U.S. solicitor general urged the Supreme Court to review a controversy over so-called skinny ...

Tarlatamab-dlle received FDA approval for ES-SCLC after showing a 40% reduction in death risk compared with chemotherapy in the DeLLphi-304 trial. The trial demonstrated improved overall survival ...

President Donald Trump has repeatedly claimed that military strikes on suspected drug boats his administration has been carrying out for more than two months in the Caribbean Sea and Pacific Ocean are ...

The FDA has converted its accelerated approval to a standard one for tarlatamab in extensive-stage small cell lung cancer. The FDA has converted its 2024 accelerated approval of tarlatamab-dlle ...

Sevabertinib received accelerated FDA approval for HER2 TKD-mutant nonsquamous NSCLC, showing a 71% ORR in the SOHO-01 trial. The treatment demonstrated a tolerable safety profile, with diarrhea as ...