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.
Pfizer’s novel breast cancer drug Ibrance shows reasonable evidence of clinical benefit to warrant marketing it ahead of a Phase III study, the FDA said in granting accelerated approval Tuesday. Read More
Generic drugmakers charge a December draft guidance doesn’t go far enough in enabling them to obtain bioequivalence testing batches for drugs protected by REMS product safety protocols. Read More
The FDA has given a Teva subsidiary the first greenlight for a generic Nexium in a snub to Ranbaxy, which is suing the agency after having its ANDA first-filer status on the therapy revoked over GMP violations at its India plants. Read More
The European Medicines Agency has extended its pilot program for coordinating international generic drug applications. Under the pilot, drugmakers can make joint submissions through the EU’s centralized procedure and the regulatory authorities of Australia, Canada, Taiwan and Switzerland. Read More
The FDA has green-lighted Eli Lilly and Boehringer Ingelheim’s combination treatment Glyxambi as an adjunct to diet and exercise for adults with type 2 diabetes. Read More
The FDA has upgraded its rating on Fresenius’ APP Pharmaceuticals’ New York plant, clearing the facility, which had been troubled by pest problems, to produce new drugs for Fresenius’ Kabi arm. Read More
Beginning last month, all NDAs will undergo a risk assessment by a team of FDA reviewers that will follow the drug from preapproval through manufacturing and into any eventual generic forms in an effort to ensure quality throughout a product’s lifecycle. Read More
The FDA on Thursday approved two fixed-dose combination therapies aimed at lowering viral loads and reducing treatment failure rates in patients with HIV. Read More