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Regulatory Intelligence & Drug Approvals2 weeks agoGeneric Drug Research Priorities & Projects
In accordance with the Generic Drug User Fee Amendments (GDUFA), FDA consults with industry and the public to create an annual list of regulatory science initiatives...
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Regulatory Intelligence & Drug Approvals2 weeks agoJemperli label extended to include rectal cancer
GSK's PD-1 inhibitor Jemperli has been cleared by the FDA as the first pre-operative cancer immunotherapy for rectal cancer.
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Regulatory Intelligence & Drug Approvals2 weeks agoOver-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.
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Regulatory Intelligence & Drug Approvals2 weeks agoEngaging with Stakeholders to Bring Nonprescription Drug Products to Market
FDA is committed to working with stakeholders and drug developers to identify and develop safe and effective nonprescription drug products, including through the drug application process....
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Regulatory Intelligence & Drug Approvals2 weeks agoRohto Pharmaceutical Co., Ltd. – 733215 – 10/14/2026
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
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Regulatory Intelligence & Drug Approvals2 weeks agoFDA Issues Final Guidance on Prescription Drug Apps and Software
The U.S. Food and Drug Administration today released final guidance establishing a clear framework for how drug companies can develop, distribute, and label apps used alongside...
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Regulatory Intelligence & Drug Approvals2 weeks agoRegulatory Considerations for Prescription Drug Use-Related Software
Regulatory Considerations for Prescription Drug Use-Related Software
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Regulatory Intelligence & Drug Approvals2 weeks agoEarly Alert: Cardinal Health Issues Correction for Presource Packs Containing BD Alaris Pump Infusion Sets
Cardinal Health Presource Kits containing recalled BD Alaris Pump Infusion Sets should be corrected prior to continued use.
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Regulatory Intelligence & Drug Approvals2 weeks agoJemperli (dostarlimab-gxly) Approved in US as First and Only Immunotherapy for Adults with MSI-H/dMMR Locally Advanced Rectal Cancer
Philadelphia, PA -- October 19 2026 -- GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly) as the...
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Regulatory Intelligence & Drug Approvals2 weeks agoFDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery
The U.S. Food and Drug Administration today granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab-gxly) that may allow some patients with locally...
Widespread atropine use fails to sway FDA advisors on Sydnexis data
At least 11 PDUFAs on FDA’s November docket
Acumen Pharmaceuticals Announces Topline Results from Phase 2 ALTITUDE-AD Clinical Trial of Sabirnetug (ACU193) for the Treatment of Early Alzheimer’s Disease; Trial Did Not Meet Primary Endpoint
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
