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 FDA Tuesday outlined new deadlines and procedures for the way drugmakers seek and conduct meetings with the agency before and during reviews of new product submissions. Read More
Sponsors of brand, generic and biosimilar drugs applying for marketing authorization through the EU’s centralized procedure must begin including facility inspection information in their applications. Read More
Astellas Pharma will launch its antifungal drug Cresemba in the coming months, following FDA approval for adults with invasive aspergillosis and invasive mucormycosis — rare, but serious fungal infections most often seen in patients with compromised immune systems. Read More
Bristol-Myers Squibb and Pfizer’s Eliquis won a positive nod in the UK, with the National Institute for Health and Care Excellence deeming it clinically effective and cost-effective in treating and preventing blood clots in the lungs, pelvis, legs or arms. Read More
The FDA Friday gave a green light to the first U.S. biosimilar, finding Sandoz’s Zarxio clinically comparable to Amgen’s blockbuster chemotherapy product Neupogen. Read More
Bristol-Myers Squibb's cancer drug Opdivo has gained a new indication as a second line treatment for metastatic squamous non-small cell lung cancer that has progressed after platinum-based chemotherapy. Read More
European regulators have granted Celgene’s nanotechnology-based therapy Abraxane its third cancer indication as a first-line treatment alongside carboplatin for non-small cell lung cancer patients who don’t qualify for surgery or radiation therapy. Read More
The FDA has postponed an advisory committee meeting that had been scheduled to consider Celltrion’s application for a biosimilar to Janssen’s Remicade — just the second advisory committee meeting to consider a biosimilar application in the U.S. Read More
The FDA is seeking additional comment from industry on its highly controversial proposed rule giving generics makers the same authority brandmakers have to update their product labels without agency approval when new safety information about a drug emerges. Read More