Nearly 40 generic medications—most prescription, but some sold over-the-counter at Amazon and Walmart—have been recalled due ...

Treatments for COPD, psoriasis, and neuroendocrine tumors, as well as a next-generation COVID-19 vaccine are under review.

In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court ...

Mirum announced the FDA approved a new tablet formulation of Livmarli for the treatment of cholestatic pruritus in patients with Alagille ...

Fate Therapeutics (FATE) announced that the U.S. Food and Drug Administration, FDA, granted Regenerative Medicine Advanced Therapy, RMAT, ...

On March 28, the FDA approved Imfinzi for use in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent Imfinzi as adjuvant treatment after radical cystectomy, ...

China's commitment to supporting the R&D and market entry of imported innovative drugs underscores its broader efforts to open up the pharmaceutical ... approach to drug development, said a ...

April 2 (UPI) --The U.S. Supreme Court on Wednesday upheld an FDA decision that rejected a series of applications to market fruit-flavored liquid vapes, which health officials contend are more ...

(CNN) — The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on track to be cleared until Tuesday afternoon, a person familiar ...

(CNN) — The Supreme Court on Wednesday backed a series of decisions by the US Food and Drug Administration to deny market access for flavored vaping products in a rare win for government ...