Servier’s Vorasidenib Enters China’s SPARK Program – First Dual IDH Inhibitor for IDH‑Mutant Glioma
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) issued a...
Policy / Regulatory
FDA Issues Boxed Warning on Elevidys (delandistrogene moxeparvovec‑rokl) – Use Limited to Ambulatory DMD Patients Aged 4+
The U.S. Food and Drug Administration (FDA) announced a Boxed Warning for Elevidys, Sarepta Therapeutics’...
FDA Announces New ‘Plausible‑Mechanism’ Pathway to Rapid Approvals for Rare Disease Treatments
The U.S. Food and Drug Administration (FDA) announced on Wednesday a landmark regulatory shift that could...
NHSA Pilot AI Review Accelerates Full‑Process Medical Insurance Assessment in 7 Chinese Provinces
The National Healthcare Security Administration (NHSA) has announced a three‑phase, AI‑powered review pilot covering Beijing,...
US FDA’s CNPV Fast‑Track Program Expands to 15 Drugs, Cutting Review Time to Months
The Commissioner’s National Priority Voucher (CNPV) pilot has just added 15 therapies to its two‑batch...
NHSA Concludes 2025 National Basic Medical Insurance Drug Catalogue Negotiation and Commercial Insurance Innovative Drug Price Talks
The National Healthcare Security Administration (NHSA) wrapped up a week‑long series of negotiations and bidding...
China CDE Opens Public Comment on 100th Batch of Reference Standards for Chemical Generic Drugs
The China Center for Drug Evaluation (CDE) has released a draft list of the 100th...
China’s National Health Commission Launches “Silver‑Haired” Healthcare & Elderly‑Care Initiative
The National Health Commission (NHC) has issued a formal notice to roll out the Silver‑Haired...
China’s National Health Commission Issues “AI + Healthcare” Implementation Opinions – Roadmap for 24 Standardized Applications
The National Health Commission (NHC) today released the Implementation Opinions on Promoting and Standardizing the...
Guangzhou’s 12‑Step Plan to Accelerate Innovative Drug and Device Adoption
The Guangzhou Municipal Health Commission issued a comprehensive notice detailing twelve strategic measures aimed at...
NHSA Re‑designs Drug‑Prescribing Surveillance, Targeting Illicit Use and Resale
The National Healthcare Security Administration issued a comprehensive notice to strengthen the intelligent monitoring of...
FDA Issues Draft Guidance to Accelerate Biosimilar Development and Cut Costs
The U.S. Food and Drug Administration (FDA) released a draft guidance titled “Scientific Considerations in...
FDA CDER Director George Tidmarsh Placed on Leave Amid Probe Over Drug‑Approval Program Concerns
The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) confirmed that...
MediCare Negotiation Begins: 535 Generic Drugs Reviewed for 2025 Drug Catalogue
The 2025 National Medical Insurance (MediCare) Negotiation kicked off at 8:30 AM, marking the start of...
National Health Commission Unveils Fourth Drug List for Generic Development
The National Health Commission (NHC) today released its fourth catalogue of medicines earmarked for generic...
SSY Group Limited Projected to Win 12 Products in China’s Eleventh VBP Round
China‑based SSY Group Limited (HKG: 2005) announced today that it has been pre‑selected as the...
NMPA Releases Draft Measures on Drug Quality Sampling, Seeks Public Comments by Nov 5
The National Medical Products Administration (NMPA) today issued the “Measures for the Administration of Drug...
Novartis Asciminib Enters China’s SPARK Program for Pediatric Chronic Myeloid Leukemia
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced today...
NMPA Expands Reference Listed Drugs List to 98 Items for Chemical Generic Drugs
China’s National Medical Products Administration (NMPA) today released its 98th Reference Listed Drugs (RLD) list...
VBP 11th Finalizes 389 Participants, 3.7 Billion Doses Set for Centralized Procurement
The Office of the National Drug Joint Procurement (ONDJP) published the conclusive enterprise roster for...