Proposed removal of risk statements about cardiovascular diseases, breast cancer, and probable dementia from the Boxed Warnings, as well as other proposed safety-related labeling changes, to clarify the benefit/risk considerations for these drugs
The study by a team at The University of Manchester, working in collaboration with AstraZeneca, showed that heating together two common, inexpensive chemicals, a type of azo compound and a formate salt, in a standard industrial reactor, can drive a wide range of chemical transformations.
After trailing its decision to look for alternatives for its cell therapy business since May, Galapagos has decided to wind it down and refocus.
On November 6, 2025, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adults with high-risk smoldering multiple myeloma (SMM).
FDA published a new batch of draft product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating evidence to support abbreviated new drug application (ANDA) approvals. FDA publishes PSGs to help facilitate generic drug development, streamline ANDA assessment, and support greater access to safe, effective, and high-quality treatments.
EMA, in collaboration with European healthcare professional and consumer organisations, has launched a new awareness campaign on medicine shortages. The #ItTakesATeam campaign highlights the shared efforts to prevent and manage shortages across the EU, and the role of each actor in supporting patients faced with these shortages.
The U.S. Food and Drug Administration (FDA) has approved Linzess (linaclotide) capsules for pediatric patients 7 years and older with irritable bowel syndrome with constipation (IBS-C). Linzess is the first treatment approved for IBS-C in pediatric patients.
The U.S. Food and Drug Administration (FDA) approved Kygevvi (doxecitine and doxribtimine) powder to treat thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients who start to show symptoms when they are 12 years old or younger. Kygevvi received Breakthrough Therapy Designation for this indication.
