Regulatory & Policy
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
UroGen's UGN-501 oncolytic virus gains FDA clearance for non-muscle invasive bladder cancer trial
UroGen Pharma (Nasdaq: URGN) announced on July 8, 2026 that the US FDA cleared its Investigational New Drug application for UGN-501, an oncolytic virus...
Immunome advances varegacestat toward approval as second oral option for desmoid tumors
The US FDA has accepted for review the New Drug Application submitted by Bothell, Washington-based Immunome, Inc. (Nasdaq: IMNM) for varegacestat (formerly...
EMA begins phased review of Revolution's daraxonrasib as FDA filing nears completion
Revolution Medicines (Nasdaq: RVMD) has initiated a rolling submission of a New Drug Application (NDA) to the US FDA for daraxonrasib (RMC-6236), an...
Saol Therapeutics resubmits rare mitochondrial disease drug after FDA agreement
Roswell, Georgia-based Saol Therapeutics has resubmitted its New Drug Application (NDA) to the US FDA for SL1009 (sodium dichloroacetate, or DCA), seeking...
Organogenesis advances first amniotic tissue biologic to FDA review for knee osteoarthritis
The US FDA's acceptance of a Biologics License Application (BLA) for Amnuvx (azimplacel, formerly Renu) — a cryopreserved amniotic suspension allograft for...
Pharvaris advances first bradykinin B2 antagonist for on-demand HAE treatment to FDA review
Pharvaris N.V. (Nasdaq: PHVS) has submitted a New Drug Application to the US FDA for deucrictibant immediate-release (IR) capsule (20 mg) for the on-demand...
China's CDE launches PIONEER Program to advance NAMs in drug development
Category: Science & Innovation Policy | Regulatory Body: CDE (Center for Drug Evaluation, NMPA) | Geography: China | Instrument: Initiative launch
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