AstraZeneca has already provided the requested information to the FDA and a decision on the updated BLA is expected in the first half of 2026.

Intravenous tenecteplase does not improve vision recovery and is associated with greater incidence of adverse events ...

Significantly longer progression-free survival seen with addition of palbociclib to maintenance anti-HER2 and endocrine therapies.

Topline data were announced from a phase 3 trial evaluating CagriSema (cagrilintide/semaglutide) in patients with type 2 diabetes (T2D) inadequately ...

Findings from the LEAP2MONO study support the regulatory submission of venglustat for treatment of type 3 Gaucher disease.

The FDA has requested new human factors and pharmacology studies for Anaphylm sublingual film following deficiencies in original NDA packaging data.

Zanzalintinib is an investigational oral agent that inhibits tyrosine kinase receptors associated with cancer growth, including TYRO3, VEGF, MET, AXL, and MER.

Yuvezzi, a combination cholinergic agonist and alpha-adrenergic agonist, is now FDA-approved as a once-daily treatment for ...

“Certainty is something our rules provide by placing the burden of perfecting service on the plaintiff,” noted the Court in its decision. The civil procedure rules “make clear that a civil action is ...

HealthDay News — More than 31,000 nurses and health care workers walked off the job Monday morning at Kaiser Permanente ...

Under the new rules, OPOs would have to better track how these organs are recovered and used. CMS said these organs often need “special or additional considerations” when finding the right recipient.

HealthDay News — Greater use of generative artificial intelligence (AI) is associated with modestly but statistically significantly greater depressive symptoms, according to a study published online ...