FDA Approves First Generic Estradiol Vaginal Insert for Treatment of Moderate to Severe Dyspareunia
The U.S. Food and Drug Administration today approved the first generic version of Imvexxy® (estradiol vaginal inserts). This approval will…
FDA Qualifies First AI Drug Development Tool, Will Be Used in ‘MASH’ Clinical Trials
FDA has qualified the first AI drug development tool, the AI-Based Histologic Measurement of NASH (AIM-NASH), to help pathologists assess…
Generic Drugs Program Fiscal Year 2025 Activities Report
As outlined in the GDUFA III Commitment Letter, these performance metrics must be reported each fiscal year.
FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma
On December 4, 2025, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company)…
Over-the-Counter OTC | Nonprescription Drugs
Over-the-counter (OTC) drugs are developed under the OTC Monograph Process or through the New Drug Application (NDA) Process.
Drug Trials Snapshot: LYNOZYFIC
LYNOZYFIC is a bispecific antibody used to treat a type of cancer called multiple myeloma. Learn more about the drug…
Assessing the Effect of Probiotics in the Steroidal Module of the Athlete’s Biological Passport
Analyses of in vitro and in vivo experiments suggest that vaginal probiotics do not substantially affect urinary steroid markers and the Athlete…
FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma
On December 3, 2025, the Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for…
What are the Qualifications and Requirements of RDRC Membership?
Criteria to be met by members of Radioactive Drug Research Committees
What Information Does the RDRC Review?
Determining if basic research proposals meet requirements