Regulatory & Policy
FDA consolidates cell and gene therapy development guidance
Category: Regulatory Policy | Regulatory Body: FDA/CBER | Geography: United States | Policy Instrument: Guidance document
FDA approves Regeneron’s Pasatru as second therapy for rare bone disease FOP
The US FDA has approved Pasatru (garetosmab-grts), a fully human anti-Activin A monoclonal antibody developed by Regeneron Pharmaceuticals (Nasdaq: REGN),...
Teva's first-in-class Tourette drug filed for approval with FDA priority status
The US FDA has accepted Teva Pharmaceutical Industries' (NYSE: TEVA) New Drug Application for ecopipam (EBS-101), a selective dopamine D1 receptor...
FDA approves Genglycos as first gene therapy for glycogen storage disease type Ia
The US FDA has granted accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr), an AAV8 gene therapy developed by Novato, California-based...
858 Therapeutics' PARG inhibitor gets second fast-track award for breast cancer
San Diego-based 858 Therapeutics announced receipt of US FDA Fast Track Designation for ETX-19477, an oral poly(ADP-ribose) glycohydrolase (PARG) inhibitor,...
FDA seeks input on regulatory framework for generative AI-enabled medical devices
Category: Regulatory Policy | Regulatory Body: FDA | Geography: United States | Policy Instrument: Guidance document | Topics: AI in drug development ·...
Faeth's PIKTOR combo gets FDA fast track for biomarker-selected endometrial cancer
Austin, Texas-based Faeth Therapeutics (Nasdaq: FTH) announced receipt of US FDA Fast Track Designation for sapanisertib and serabelisib (PIKTOR) in...
China moves quickly on ICH E6(R3) Annex 2 with March applicability date
Category: Clinical Trial Reform | Regulatory Body: NMPA (CDE) | Geography: China | Instrument: Guidance document
China NMPA sets framework for direct role in national R&D funding
Category: Research Policy | Regulatory Body: NMPA (National Medical Products Administration) | Geography: China | Policy Instrument: Guidance document
US FDA approves Lantheus’ Tauklarify as second tau PET tracer for Alzheimer’s disease
The US FDA has approved Tauklarify (florquinitau F 18 injection, also known as MK-6240), a radiodiagnostic positron emission tomography (PET) agent for...
Biogen's felzartamab wins first global approval in China for multiple myeloma
China's National Medical Products Administration (NMPA) has approved Jingshu (felzartamab), an anti-CD38 monoclonal antibody, in combination with...
Pfizer, Valneva Lyme vaccine enters EU review after Phase III
The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for PF-07307405, the 6-valent outer surface protein A...
BMS scores first CELMoD approval as FDA embraces MRD surrogate
Bristol Myers Squibb has received US FDA accelerated approval for Zenbexus (iberdomide), the first cereblon E3 ligase modulating drug (CELMoD) to reach the...
Youcare takes Factor XI siRNA into US anticoagulation race
China-based Youcare Pharmaceutical Group (SSE: 688658) received US FDA clearance to proceed with clinical trials of YKYY033 injection, a GalNAc-conjugated...
AC Immune takes Parkinson's vaccine into US trials as Phase II data near
Switzerland-based AC Immune SA (Nasdaq: ACIU), a clinical-stage biopharmaceutical company focused on neurodegenerative diseases, announced receipt of US FDA...
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