Arguably the most notable of the FDA’s upcoming decisions is that regarding Gilead’s twice-yearly HIV prophylaxis lenacapavir ...

An FDA advisory committee on Wednesday unanimously voted against recommending approval of the PARP inhibitor talazoparib ...

The U.S. Food and Drug Administration (FDA) has approved Sanofi’s (NASDAQ:SNY) meningococcal vaccine MenQuadfi for infants as ...

The FDA biologics license application for patritumab deruxtecan in EGFR+ NSCLC has been withdrawn following discussions with ...

Roche RHHBY announced today that the FDA has approved a label expansion of ophthalmology drug Susvimo (ranibizumab injection). The regulatory body approved the drug Susvimo for the treatment of ...

In calling for more clinical testing of vaccines in younger people and those who face a low risk of severe disease from Covid ...

YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar ...

The FDA had given Pfizer and Moderna until May 17 to propose changes to the labels of their COVID-19 vaccines or challenge ...

The COPD approval marks the fifth Nucala has received from the FDA, following green lights in severe asthma, chronic ...

Branded drugs, including Synthroid, Lipitor, and Nexium, had a legacy use of talc, and they still contain it, Tidmarsh said ...