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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 regulations that could impact your business. Read More
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 popularity of these drugs also continues to expand. Read More
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 applications for certain solid wound dressings; wound dressings formulated as a gel, cream, or ointment and liquid wound washes containing antimicrobials with a high level of antimicrobial resistance. Read More
Namandje Bumpus, currently chief scientist for the FDA, will replace Janet Woodcock as principal deputy commissioner, FDA Commissioner Robert Califf announced Wednesday. Read More
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, accelerating AbbVie’s presence in the solid tumor space. Read More
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 an eight-day October inspection of its Mumbai, Maharashtra sterile drug manufacturing facility. Read More
Novo Nordisk has filed complaints against two Florida-based compounding pharmacies for marketing unapproved versions of its semaglutide products, claiming the products are weaker in strength than labeling indicates and may contain up to 33 percent impurities. Read More
Upcoming events in the coming weeks and months include two FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on medical device cybersecurity, overcoming common clinical trial challenges, supplier quality agreements and FDA inspections. Read More
After receiving reports of T-cell malignancies in patients who received treatment with BCMA- or CD19-directed autologous CAR-T cell immunotherapies, the agency has announced an investigation into the issue and is evaluating the need for regulatory action. Read More