FDA Addresses Looming Migraine Treatment Shortage with Tonix Pharmaceuticals Commitment
The US Food and Drug Administration (FDA) is actively engaging with pharmaceutical companies to address...
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Henan Zhongshuai’s Dexmethylphenidate Hydrochloride Capsules Target Priority Review for Pediatric ADHD
Henan Zhongshuai Pharmaceutical Co., Ltd., a China-based pharmaceutical company, is poised to secure priority review...
Amneal Pharmaceuticals Receives China Approval for Sevelamer Carbonate
US-based Amneal Pharmaceuticals Inc. (NYSE: AMRX) has announced that it has received approval from the...
CSPC Pharmaceutical’s Narlumosbart Approved by NMPA for Bone Giant Cell Tumors
CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its subsidiary, Shanghai JMT Biotechnology Co.,...
Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for CDE’s BTD Status
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its HER2 targeted antibody-drug...
NMPA Drafts Guidelines for Supervising Online Drug Exchange Platforms
The National Medical Products Administration (NMPA) has released draft “Online Third-party Drug Exchange Platforms Inspection...
Genentech Files for FDA Approval of Crovalimab for PNH, Challenging Soliris
Swiss pharmaceutical giant Roche’s subsidiary, Genentech (SWX: ROG), has submitted its anti-C5 investigational drug, crovalimab,...
uBriGene and YolTech Therapeutics Join Forces to Advance mRNA Therapy and Gene Therapy
China-based uBriGene Biosciences Inc., a prominent contract development and manufacturing organization (CDMO) specializing in cell...
CDE’s 2022 Drug Review Report: A Year of Pandemic Response and Regulatory Milestones
The Center for Drug Evaluation (CDE) has released its comprehensive 2022 annual drug review report,...
Hainan Haiyao Concludes Phase I Clinical Study for PaiEnJiaBin, a Novel KCNQ Agonist
China-based Hainan Haiyao Co., Ltd (SHE: 000566) has announced the conclusion of Phase I clinical...
Sino Medical Sciences Technology to Acquire Majority Stake in US Endovascular Device Firm eLum
China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced plans to acquire a 72.73%...
Acotec Scientific Holdings Receives Marketing Approvals for Vericor-14 Microcatheter in Japan and Thailand
China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced that it has received marketing approvals...
Brii Biosciences Announces Positive Interim Data for BRII-179 Vaccine in Chronic Hepatitis B
China-based Brii Biosciences Ltd (HKG: 2137) has announced topline cohort-level unblinded Week 36 data from...
MSD’s Gardasil 9 HPV Vaccine Demonstrates 10-Year Efficacy in Adolescents
Merck, Sharp & Dohme (MSD; NYSE: MRK) has released long-term effectiveness data for its recombinant...
Sinovac Biotech Directors Reject Alternative Liquidity’s Lowball Tender Offer
China-based Sinovac Biotech Ltd. (NASDAQ: SVA) announced that its Board of Directors has unanimously determined...
Abbott to Acquire Insulin Management Firm Bigfoot Biomedical
Healthcare giant Abbott (NYSE: ABT) has announced an agreement to purchase Bigfoot Biomedical, a company...
Taizhou Port Designated as Drug Import Port by NMPA and General Administration of Customs
The National Medical Products Administration (NMPA) and the General Administration of Customs have released a...
Sandoz Reports H1 2023 Financials with 8% YOY Growth, Separation from Novartis Looms
Switzerland-based Sandoz (SWX: SDZ) has published its financial statements for the first half of 2023,...
Li Li Appointed as New Director of NMPA
The State Council has released an announcement regarding appointments and dismissals within the government. Among...
NHSA Mandates National Standards for Medical Consumables in Basic Medical Insurance
The National Healthcare Security Administration (NHSA) has released a notification with a focus on enhancing...