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 submitted Designation of Official Names and Proper Names for Certain Biological Products as a proposed rule to the Office of Management and Budget on Friday, but would not comment on whether it is the expected guidance on naming biosimilars. Read More
A drug pricing watchdog was rebuffed Monday in its attempt to get the U.S. Patent and Trademark Office to review two patents on Acorda Therapeutics’ blockbuster multiple sclerosis drug Ampyra — the first of 18 petitions the Coalition for Affordable Drugs has filed with the agency since February. Read More
California drugmaker Medivation is acquiring the worldwide rights to BioMarin’s breast cancer drug talazoparib, in a move aimed at diversifying and expanding its global oncology footprint. Read More
The FDA and European Medicines Agency have accepted new drug applications for Boehringer Ingelheim’s Gilotrif as a treatment option for patients with advanced squamous cell lung cancer that has progressed after treatment with first-line chemotherapy. Read More
Seattle Genetics received a six-observation Form 483 from the FDA for documentation and adverse event reporting failures related to its only approved product — cancer drug Adcetris. Read More
The FDA appears to have anticipated one issue drugmakers raised at a Monday public meeting on its quality metrics draft guidance — extending the comment period on the document until Nov. 27. Read More
The agency wants to improve nomenclature following complaints by generic drug and excipient makers that the current format delays ANDA filings. Read More