Regulatory & Policy
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...
FDA accepts Gilead's once-weekly oral lenacapavir as first long-acting HIV PrEP pill
The US FDA's acceptance of a supplemental New Drug Application (sNDA) for once-weekly oral lenacapavir as pre-exposure prophylaxis (PrEP) represents a...
FDA accepts Takeda's Entyvio application for pediatric ulcerative colitis and Crohn's disease
Pediatric patients with inflammatory bowel disease represent one of the most therapeutically underserved populations in gastroenterology, and Takeda's...
Innovent global first to seek approval for CLDN18.2 targeted ADC in China
China-based Innovent Biologics (HKEX: 01801) has submitted a New Drug Application (NDA) to China's National Medical Products Administration (NMPA) for...
FDA accepts Roche's giredestrant NDA for early-stage ER-positive breast cancer adjuvant treatment
Roche (SIX: RO, ROP; OTCQX: RHHBY) has submitted a New Drug Application (NDA) to the US FDA for giredestrant, an investigational oral selective estrogen...
Replimune to resubmit BLA for oncolytic IO therapy Rp1 in melanoma after FDA alignment
Woburn, Massachusetts-based Replimune Group (Nasdaq: REPL) has announced plans to resubmit a Biologics License Application (BLA) to the US FDA for Rp1...
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