Regulatory & Policy
Larimar advances first Friedreich's ataxia drug toward accelerated FDA approval with novel surrogate endpoint
Bala Cynwyd, Pennsylvania-based Larimar Therapeutics (Nasdaq: LRMR) has submitted the first module of a rolling Biologics License Application (BLA) to the...
Mesoblast advances first cellular therapy for life-threatening LVAD complications
Australia-based Mesoblast Limited (ASX: MSB; Nasdaq: MESO) has received a Biologics License Application filing number from the US FDA and requested a...
Nicox's NCX 470 advances to FDA review as first nitric oxide-donating glaucoma therapy
Kowa Company, Ltd.'s submission of a New Drug Application (NDA) to the US FDA for NCX 470 (bimatoprost grenod), developed by France-based Nicox SA (Paris:...
FDA launches PreCheck Pilot program to accelerate domestic drug manufacturing facility approvals
Category: Regulatory Policy | Regulatory Body: FDA | Geography: United States | Instrument: Initiative launch
Viatris ready to seek Japan approval for Tarpeyo in IgAN after positive readout
Viatris Inc. (Nasdaq: VTRS) is targeting submission of a New Drug Application to Japan's Ministry of Health, Labour and Welfare (MHLW) for Tarpeyo/Kinpeygo...
FDA Schedules Advisory Committee for Capricor's Deramiocel in Duchenne Muscular Dystrophy
San Diego-based Capricor Therapeutics (Nasdaq: CAPR) has announced that the US FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) will...
CHMP June 2026: Trofinetide reversal, avacopan revocation, and 6 new medicines advance toward EU approval
The EMA's Committee for Medicinal Products for Human Use concluded its June 2026 meeting with a series of consequential decisions: a rare reversal of a...
MaaT Pharma challenges EMA rejection of Xervyteg with re-examination request for aGvHD
France-based MaaT Pharma (Euronext: MAAT) has announced its intention to request a re-examination of the negative opinion issued by the European Medicines...
CeleCor seeking approval for zalunfiban as first antiplatelet therapy for pre-hospital STEMI care
Del Mar, California-based CeleCor Therapeutics has completed submission of a New Drug Application (NDA) to the US FDA for Disaggpro (zalunfiban), an...
HHS launches Operation Trialblazer to reverse offshoring of early-phase clinical research
Category: Clinical Trial Reform | Regulatory Body: HHS | Geography: United States | Instrument: Initiative launch
Regenxbio's Navsunli clears FDA path toward first gene therapy for Hunter syndrome
Rockville, Maryland-based REGENXBIO Inc. (Nasdaq: RGNX) has announced alignment with the US FDA on a path forward for resubmission of the Biologics License...
Regeneron seeking approval for cemdisiran as first siRNA therapy for generalized myasthenia gravis
Regulatory applications for cemdisiran, a small interfering RNA (siRNA) therapeutic targeting complement factor C5, have been accepted for review by both...
Teva files Emalex's ecopipam with US FDA for first approval as Tourette's therapy
Teva Pharmaceutical Industries (NYSE: TEVA) has submitted a New Drug Application (NDA) to the US FDA for ecopipam, an investigational selective dopamine D1...
Roche files Lunsumio Velo plus Polivy for approval as first bispecific-ADC combo against lymphoma
The US FDA's acceptance of a supplemental Biologics License Application for Lunsumio Velo (mosunetuzumab) in combination with Polivy (polatuzumab vedotin)...
FDA backs uniQure's three-year data package for AMT-130 accelerated approval filing
uniQure N.V. (Nasdaq: QURE) has announced plans to submit a Biologics License Application (BLA) to the US FDA seeking accelerated approval of AMT-130 for...
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