Guangzhou LBP Earns NMPA Nod for HER2 Detection Reagent to Guide Breast Cancer Treatment
Guangzhou LBP Medicine Science & Technology Co., Ltd (SHA: 688393), a biopharmaceutical company based in...
Product approvals
Innovent Biologics’ Pemazyre Wins Macau Approval for Cholangiocarcinoma Treatment
Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company in China, has received marketing approval...
China Medical System’s Opzelura Approved in Macau for Vitiligo Treatment
China Medical System Holdings (CMS; HKG: 0867) has announced that it has received market approval...
3SBio Secures NMPA Approval for Pediatric Thrombopoietin Treatment of ITP
3SBio Inc. (HKG: 1530), a leading biopharmaceutical company based in China, has announced that it...
AstraZeneca’s Fasenra Gains FDA Approval for Pediatric Severe Asthma Treatment
AstraZeneca (AZ; NASDAQ: AZN) has secured an indication extension from the U.S. Food and Drug...
Qilu Pharmaceutical Gets NMPA Green Light for Generic Romiplostim for ITP Treatment
The National Medical Products Administration (NMPA) in China has granted marketing approval to Qilu Pharmaceutical...
GSK’s ViiV Healthcare Expands Dovato Indication to Include Adolescents with HIV-1 Infection
GlaxoSmithKline’s (GSK; NYSE: GSK) ViiV Healthcare has received an indication extension from the US Food...
AstraZeneca and Daiichi Sankyo’s Enhertu Secures FDA Approval for HER2-Positive Solid Tumors
Partners AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have been granted an additional...
Bristol Myers Squibb’s Abecma Receives FDA Approval for Wider Use in Multiple Myeloma Treatment
The US Food and Drug Administration (FDA) has granted an indication extension for Bristol Myers...
Junshi Biosciences’ Toripalimab Approved for First-Line RCC Treatment in China
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has received a new indication approval...
Ipsen Secures NMPA Approval for Somatuline in Advanced Neuroendocrine Tumors
Ipsen (EPA: IPN; OTCMKTS: IPSEY), a France-based biopharmaceutical company, has received new indication approval from...
Mabwell Bioscience Receives NMPA Approval for Biosimilar Version of Amgen’s Xgeva
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received market approval...
Legend Biotech’s Carvykti Secures FDA Approval for Expanded Use in Multiple Myeloma
China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced that the US Food and Drug Administration...
European Commission Approves Reblozyl for First-Line Treatment of MDS-Related Anemia
The European Commission (EC) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension...
Hepalink Secures TFDA Approval for Enoxaparin Sodium Injection, Expanding Thrombosis Treatment Options in Thailand
Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), based in China, has announced that it...
Sino Medical Secures Approval for Innovative Drug-Coated Stent System Targeting Intracranial Stenosis
Sino Medical Sciences Technology Inc. (SHA: 688108), based in China, has announced that it has...
Alexion’s Voydeya Earns FDA Nod as Add-on Therapy for PNH-Associated Extravascular Hemolysis
Alexion, the rare disease unit of AstraZeneca (AZ; NASDAQ: AZN) based in the UK, has...
Huihe Healthcare’s Vispearl Microsphere Earns Marketing Approval in China for Innovative Cancer Treatment
Shanghai-based Huihe Healthcare, a developer of interventional medical devices for structural heart diseases, has secured...
AstraZeneca’s AKT Inhibitor Truqap Approved in Japan for HR+, HER2- Breast Cancer
AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, has registered with Japan’s Ministry of Health,...
Hepalink’s Enoxaparin Sodium Injection Receives Marketing Approval in New Zealand
Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), a prominent pharmaceutical company based in China,...