[ Price : $8.95]
FDA grants Zai Lab an orphan drug designation to ZL-1310, an antibody-drug conjugate for treating small cell lung cancer.[ Price : $8.95]
Three Ropes & Gray attorneys review major FDA-related enforcement cases in 2024 and say it is impossible to predict with certainty...[ Price : $8.95]
Two medical device stakeholders suggest ways for FDA to regulate generative AI and foundation model-enabled medical devices.[ Price : $8.95]
A bipartisan group of senators reintroduce legislation to mandate the inclusion of drug prices in direct-to-consumer ads.[ Price : $8.95]
FDA says it is adding a Boxed Warning for anaphylaxis to the labeling for Tevas multiple sclerosis drug Copaxone and its Sandoz ge...[ Price : $8.95]
CBER director Peter Marks report for 2024 discusses Center approval of 67 products it says integrated advances in science and tech...[ Price : $8.95]
The U.S. Court of Federal Claims grants FDA summary judgment on the pleadings and rejects Vandas 5th Amendment taking argument abo...[ Price : $8.95]
The union representing FDA employees sues President Trump over efforts to replace many Civil Service workers with political appoin...