Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of ...

In a post-market statement on Jan. 16, Lykos gave a fresh update following what it described as a “productive” meeting with the FDA on Wednesday. “We continue to chart a path forward for an ...

The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...

The authors write "The Food, Drug and Cosmetic Law Section of the New York State Bar Association is delving into the changing ...

Following the ban of red dye No. 3 in the United States, experts weigh in on the potential health risks of red dye No. 40, ...

The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...

Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...

(MENAFN- EIN Presswire) Novamigra Tx Announces Successful Pre-IND Meeting with FDA for Migraine Prophylaxis Asset VRG-145, Paving Way for Accelerated Clinical Development BUDAPEST, HUNGARY ...

A high-dose form of Novo’s obesity drug led to 20% weight loss over 72 weeks. Meanwhile, Atara got a complete response letter ...

BCG unresponsive non-muscle invasive bladder cancer (NMIBC) in the papillary indication: Anticipated supplemental biologics license application (BLA) submission in 2025 Alternative source of BCG ...

An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...