The Latest Breaking News from FDA

The U.S. Food Drug Administration (FDA) on Tuesday extended review for Ascendis Pharma A/S‘ (NASDAQ:ASND) New Drug Application (NDA) for TransCon CNP (navepegritide) for children with achondroplasia.

RFK Jr signed order withdrawing rule that would mandate testing for the cancer-linked toxin in talc-based makeup

The U.S. Food and Drug Administration’s (FDA) top official ignited fresh debate on Wednesday by accusing Dr Anthony Fauci on the “Pod Force One” podcast of suppressing early scrutiny of COVID-19’s origins, calling the alleged effort a “massive cover-up” during the first months of the pandemic.

On Wednesday, Novo Nordisk A/S (NYSE:NVO) submitted its supplemental marketing application to the U.S. Food and Drug Administration (FDA) for a higher dose of semaglutide injection 7.2 mg for chronic weight management.

BiomX Inc. (NYSE:PHGE) on Tuesday announced that the U.S. Food and Drug Administration (FDA) is continuing its evaluation of the nebulizer device used for drug administration in the company's Phase 2b trial of BX004 in cystic fibrosis patients.

Johnson Johnson (NYSE:JNJ) stock has surged almost 42.9% in the year to date, approximately 35% in 6 months, and 8.6% in one month.

The U.S. Food and Drug Administration (FDA) on Tuesday approved AstraZeneca Plc's (NASDAQ:AZN) Imfinzi (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) for resectable, early-stage, and locally advanced gastric and gastroesophageal junction (GEJ) cancers.

ByHeart expands its infant formula recall after tests detect botulism-causing bacteria linked to illnesses in dozens of babies.

We often take our mundane grocery store runs for granted. Generally, we assume that everything sitting on a retail shelf is safe, tested, and entirely legal to own. However, laws change much more rapidly than we realize. What was a household staple yesterday can easily become contraband today.

The U.S. Food and Drug Administration (FDA) on Tuesday approved dosing in Sarepta Therapeutics Inc.’s (NASDAQ:SRPT) Cohort 8 of ENDEAVOR (Study 9001-103).

GOP lawmakers in Wisconsin and elsewhere are pushing the idea that abortions are a water quality issue.