Regulatory & Policy
Ivonescimab expands China label as Summit awaits US test
China's National Medical Products Administration (NMPA) has approved a supplemental New Drug Application for ivonescimab (Aqissimab) in combination with...
Small US biotechs cite FDA barriers to first-in-human trials: survey
Category: Clinical Trial Reform | Regulatory Body: FDA | Geography: United States | Policy Instrument: Initiative launch
WuXi AppTec wins court reprieve from Pentagon military designation
A US federal court has temporarily blocked enforcement of the US Department of Defense's designation of WuXi AppTec Co., Ltd. (HKEX: 2359) on its so-called...
United Labs' oral GLP-1 drug cleared for US trials
The United Laboratories International Holdings Limited (HKEX: 03933) announced on August 11 that the US FDA has cleared two investigational new drug...
Trump cuts US childhood vaccine schedule, targets MMR
Category: Regulatory Policy | Regulatory Body: HHS | Geography: United States | Policy Instrument: Executive Order
FDA blocks ITM's radiotherapy drug over manufacturing defects, clinical data intact
Germany-based ITM Isotope Technologies Munich SE received a Complete Response Letter (CRL) from the US FDA on August 7, 2026, for its New Drug Application...
GRAIL’s Galleri becomes first multi-cancer detection test headed to US FDA advisory panel
Menlo Park, California-based GRAIL, Inc. (Nasdaq: GRAL) has announced that the US FDA's Molecular and Clinical Genetics Panel of the Medical Devices...
US bill could subject China-to-US pharma licensing deals to national security controls
Category: Science & Innovation Policy | Regulatory Body: U.S. Congress (Senate) | Geography: United States | Policy Instrument: Legislation
Grand Pharma's FAP-targeted imaging agent earns FDA Fast Track designation
China-based Grand Pharmaceutical Group Limited (HKEX: 00512) announced receipt of US FDA Fast Track Designation (FTD) for GPN01530-2, a fibroblast...
Scholar Rock shifts apitegromab BLA to second fill-finish site after Catalent FDA inspection
Cambridge, Massachusetts-based Scholar Rock (Nasdaq: SRRK) announced that the FDA review of its biologics license application (BLA) for apitegromab, a...
China accepts NDA for Alebund's phosphate binder AP301 after Phase III success
Alebund Pharmaceuticals (Jiangsu) Limited (HKEX: 09637) announced on August 7, 2026 that China's National Medical Products Administration (NMPA) has...
BioInvent wins FDA Fast Track for BI-1808 after encouraging ovarian cancer data
Sweden-based BioInvent International AB (Nasdaq Stockholm: BINV) announced receipt of US FDA Fast Track Designation for BI-1808, a first-in-class anti-tumor...
Sino Bio's benmelstobart-anlotinib regimen adds new China indication in first-line squamous NSCLC
China's National Medical Products Administration (NMPA) has approved a new first-line regimen for locally advanced or metastatic squamous non-small cell...
EU clears label expansion for Bavarian Nordic's Mpox vaccine to children as young as two
The European Commission has approved a label extension for Imvanex (MVA-BN), Denmark-based Bavarian Nordic's (OMX: BAVA) non-replicating smallpox and mpox...
Replimune secures accelerated approval for oncolytic viral therapy Tudriqev
The US FDA has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy developed by...
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