FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs
FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs
Other | Cancer Accelerated Approvals
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been granted for supportive care products…
FDA Listing of Authorized Generics
FDA Listing of Authorized Generics
FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer
On April 8, 2025, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company)…
Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due to a Label Mix-up
Golden State Medical Supply, Incorporated (GSMS, Inc.) – Camarillo, CA has initiated a voluntary recall of the products listed in…
Patient-Focused Drug Development
The OCE PFDD program fosters collaboration between FDA centers and external stakeholders involved in patient outcomes research in cancer populations.
www.thesafepills.org – 702942 – 03/27/2025
Unapproved New Drugs/Misbranded
Evaluating the Early Operational Performance of the Endocrine Module in the Athlete Biological Passport
The International Testing Agency, in collaboration with various Anti-Doping Organisations and the Paris WADA-accredited laboratory, led the Endocrine Module’s implementation…
Ozempen.com – 684435 – 06/24/2024
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
Sun Pharmaceutical Industries Limited – 677337 – 06/18/2024
CGMP/Finished Pharmaceuticals/Adulterated