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.
Because its phase 3 trial was conducted only in China, the FDA has told Eli Lilly to go back to the drawing board with its promising investigational checkpoint inhibitor sintilimab for the treatment of nonsmall-cell lung cancer (NSCLC). Read More
ECI Pharmaceuticals said a warning letter it received from the FDA for listing an incorrect active pharmaceutical ingredient for its drug products was the result of a “clerical error.” Read More
India currently makes the lion’s share of active pharmaceutical ingredients (APIs), the raw materials used to create prescription drugs, for the U.S. Read More
The settlement “will further support public health efforts to respond to the challenges brought on by this epidemic,” said Rhode Island Attorney General Peter F. Neronha. Read More
Johnson & Johnson (J&J) is further curtailing its participation in the controversial 30-year-old 340B Drug Discount Program, which was designed to serve low-income patient populations in the U.S. Read More
The FDA has reclassified ophthalmic drugs packaged with eye cups, eye droppers or other dispensers as “drug-led combination products” rather than just drugs, the agency said in a final guidance. Read More
The FDA’s communications with the biosimilars industry around inspection delays have been “poor,” and its interaction with that sector of the industry around application-level communications and regulatory science hasn’t been much better. Read More
The FDA won’t weigh in on whether Regenxbio may be granted a patent extension for its adeno-associated virus (AAV) technology used to produce Novartis’ blockbuster spinal muscular atrophy (SMA) therapy Zolgensma (onasemnogene abeparvovec). Read More
Bristol Myers Squibb (BMS) is accusing AstraZeneca of infringing on several patents related to its blockbuster cancer immunotherapy Opdivo (nivolumab). Read More