As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and…

In an expansion of its investigation into suicidal ideation associated with GLP-1 agonists, the European Medicines Agency (EMA) wants manufacturers to answer some undisclosed questions about these drugs, while the…

In a strongly worded position paper, the European Commission’s Medical Device Coordination Group (MDCG) has directed device manufacturers to get certified ASAP under the new device and diagnostics regulations. Source:…

Leaks, breakage and other problems with plastic syringes manufactured in China have led the FDA to urge all users to check the manufacturing location of syringes and consider not using…

Over the past week, the FDA issued proposed rules to classify certain types of wound dressings and liquid wound washes containing antimicrobials and/or other chemicals and to require premarket approval…

Eitan Medical’s recall of 1,323 infusion pumps — for a risk that the pump may fail to detect air in the line when running on battery power — has been…

Namandje Bumpus, currently chief scientist for the FDA, will replace Janet Woodcock as principal deputy commissioner, FDA Commissioner Robert Califf announced Wednesday. Source: Drug Industry Daily

AbbVie and ImmunoGen today announced an agreement under which AbbVie will acquire ImmunoGen, and its flagship cancer therapy Elahere (mirvetuximab soravtansine-gynx) an antibody-drug conjugate (ADC) approved for platinum-resistant ovarian cancer,…

Kilitch Healthcare India received an FDA Form 483 citing lack of sterility, incomplete laboratory records and inadequate laboratory controls, inadequate validation of aseptic processes and unclean and insanitary buildings following…

Despite overall enthusiasm for the use of multi-cancer diagnostic (MCD) tests, several members of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee raised concerns about the…