We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended five drugs for approval at its final meeting of the year, including two generics and a biosimilar. Read More
The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously on Friday to support Horizon Pharma’s teprotumumab infusion to treat active thyroid eye disease (TED). Read More
The FDA hit Enzyvant with a complete response letter for its regenerative tissue therapy RVT-802, an investigational drug for a rare immunodeficiency disorder. Read More
Novartis’ blockbuster multiple sclerosis drug Gilenya (fingolimod) may soon face generic competitors in the U.S., following three FDA approvals. Read More
The FDA continued to lead the world in new molecular entity approvals in fiscal year 2019, according to a senior official in the Office of New Drugs. Read More
Lexicon Pharmaceuticals has lost its appeal to the FDA of the agency’s complete response letter in March for its investigational add-on type 1 diabetes treatment Zynquista (sotagliflozin). Read More
In a move to help sponsors of insulin biosimilar applications, the FDA spelled out the data and information needed to support immunogenicity assessments for insulin biosimilars or interchangeables in a draft guidance released on Monday.
Read More