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FDA expands the indication for a treatment for metastatic castration-resistant prostate cancer: fda.gov/drugs/resource…

FDA approves a treatment for adults with muscle invasive bladder cancer: fda.gov/drugs/resource…

📢 ICYMI! Join #CDERSBIA on April 9-10 for the Generic Drugs Forum (GDF), offering 13 CME | CPE | CNE! Learn how to enhance applications, streamline the assessment process, and reduce cycles. Don't miss this opportunity to interact with FDA! REGISTER ➡️ fda.gov/drugs/news-eve…

It’s not too late to join #CDERSBIA this week for the Generic Drugs Forum (GDF) on April 9-10! Take advantage of this opportunity to interact with FDA experts, learn from industry peers, & stay up to date on regulatory developments. Register now! ➡️ fda.gov/drugs/news-eve…

FDA approves a treatment for patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. fda.gov/drugs/resource…

#FDA approves a treatment for adult patients with unresectable or metastatic hepatocellular carcinoma fda.gov/drugs/resource…

📣 New FDA case studies published for ARC’s LEADER 3D initiative, plus updated user guide. The studies highlight sponsors’ approaches for the design and conduct of #raredisease development programs. Read now: fda.gov/about-fda/acce…

FDA approves a treatment for non-keratinizing nasopharyngeal carcinoma. Learn more: fda.gov/drugs/resource…

📣@ReaganUdall and U.S. FDA will host a virtual workshop on Primary Mitochondrial Diseases on May 22. Join experts to explore therapeutic development opportunities for rare diseases. #MitochondrialDisease #RareDisease fda.gov/drugs/news-eve…

📣Join #CDERSBIA on May 20, 2025, from 1-2 pm ET to learn about the Over-the-Counter Drug User Fee Program (OMUFA) and key elements of the program related to OMUFA user fees. Learn more & register today ➡️fda.gov/drugs/news-eve…

Are you a sponsor or applicant planning to submit new drug applications (NDAs), biologics license applications (BLAs) and NDA or BLA supplements containing new clinical study reports to CDER? View our 2-part webinar video so you’ll know what’s required. fda.gov/drugs/news-eve…

FDA grants accelerated approval to a treatment for KRAS-mutated recurrent low-grade serous ovarian cancer. fda.gov/drugs/resource…

#FDA approves first oral treatment for pheochromocytoma and paraganglioma, rare tumors that form in or outside the adrenal gland. fda.gov/drugs/resource…

FDA grants accelerated approval to treatment for non-small cell lung cancer with high c-MET protein overexpression. fda.gov/drugs/resource…

FDA approves a treatment for squamous cell carcinoma of the anal canal. fda.gov/drugs/resource…