Regulatory & Policy
Amgen submits data to FDA challenging Tavneos withdrawal proposal in rare vasculitis
Amgen (Nasdaq: AMGN) submitted data and analyses to the US FDA on July 23, 2026, in support of its request for a formal hearing on Tavneos (avacopan), the...
AstraZeneca pulls Imfinzi EU expansion after CHMP questions benefit-risk in bladder cancer
AstraZeneca's bid to expand durvalumab (Imfinzi) into high-risk non-muscle invasive bladder cancer has ended in the EU after the European Medicines Agency...
Proveca seeks re-examination of EMA rejection for pediatric intranasal pain spray KemSu
Denmark-based Cessatech said its commercialization partner Proveca intends to request a re-examination of a negative opinion issued by the European...
FDA begins review of Revolution's RAS(ON) inhibitor for pancreatic cancer
The US Food and Drug Administration has accepted for review Revolution Medicines' New Drug Application for daraxonrasib (RMC-6236), an oral RAS(ON)...
BridgeBio's encaleret advances toward first-ever ADH1 approval with FDA NDA acceptance
BridgeBio Pharma, Inc. (Nasdaq: BBIO) said the US FDA has accepted for filing its New Drug Application for encaleret, an investigational oral calcilytic, in...
Monopar advances first novel Wilson disease therapy in decades toward FDA approval
Monopar Therapeutics Inc. (Nasdaq: MNPR), the Wilmette, Illinois-based biopharmaceutical company, has initiated a rolling submission of a New Drug...
FDA accepts Camurus' resubmitted CAM2029 application for acromegaly review
Camurus AB (Nasdaq Stockholm: CAMX) said the US FDA has accepted for review its resubmitted New Drug Application for CAM2029, a long-acting subcutaneous...
Axsome advances first daytime oral therapy for cataplexy in narcolepsy toward FDA decision
New York-based Axsome Therapeutics, Inc. (Nasdaq: AXSM) said the US FDA has accepted for review its New Drug Application for AXS-12 (reboxetine), a...
Shionogi seeking to expand Fetroja use into pediatric settings
Japan-based Shionogi & Co., Ltd. said the US FDA has accepted a Supplemental New Drug Application (sNDA) for cefiderocol (Fetroja), seeking to extend the...
FDA proposes registration overhaul for distributed manufacturing and global drug supply chains
Regulatory Policy | FDA | United States | Rule/Rulemaking
FDA finalizes guidance on psychedelic drug clinical trial design and safety considerations
Category: Clinical Trial Reform | Regulatory Body: FDA | Geography: United States | Instrument: Guidance document
Apnimed's first oral OSA therapy set for FDA review and 2027 decision
Cambridge, Massachusetts-based Apnimed has submitted a New Drug Application (NDA) to the US FDA for AD109 (aroxybutynin 2.3 mg/atomoxetine 75 mg), seeking...
BMS seeking first FDA approval for molecular glue mezigdomide in heavily pretreated multiple myeloma
The US FDA has accepted for review a New Drug Application submitted by Bristol Myers Squibb (NYSE: BMY) for mezigdomide in combination with carfilzomib and...
FDA clears path for Voxzogo's conversion from accelerated to traditional approval in achondroplasia
The US FDA has accepted BioMarin Pharmaceutical Inc.'s (Nasdaq: BMRN) supplemental New Drug Application (sNDA) for Voxzogo (vosoritide) seeking full...
FDA pauses CRL publication while HHS develops formal disclosure rule
Category: Regulatory Policy | Regulatory Body: FDA | Geography: United States | Instrument: Rule/Rulemaking
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