Novartis’s Iptacopan (Fabhalta) Receives Marketing Approval in China for PNH Treatment
Swiss pharmaceutical giant Novartis (NYSE: NVS) has received marketing approval from China for its iptacopan...
Product approvals
US FDA Greenlights Henlius Biotech’s Hanquyou as Biosimilar to Roche’s Herceptin
Shanghai Henlius Biotech Inc. (HKG: 2696) has achieved a significant milestone with the US Food...
Novartis’s Lutathera Secures FDA Approval for Pediatric Gastroenteropancreatic NETs
The US Food and Drug Administration (FDA) has granted regulatory approval to Novartis (NYSE: NVS)...
European Commission Approves Pfizer’s Antibiotic Emblaveo for Multiple Indications
The European Commission (EC) has granted approval for Pfizer’s (NYSE: PFE) antibiotic Emblaveo (aztreonam +...
Sandoz’s Partner Samsung Bioepis Scores EC Approval for Stelara Biosimilar Pyzchiva
Switzerland-headquartered Sandoz (SWX: SDZ) has announced that the European Commission (EC) has granted approval for...
GenScript’s Subsidiary Legend Biotech Expands EU Approval for CAR-T Therapy Carvykti
China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary,...
Roche’s Alecensa approved by FDA as First ALK Inhibitor for Adjuvant Treatment of NSCLC
Roche Holding AG (SWX: ROG; OTCMKTS: RHHBY), a Swiss multinational healthcare company, announced last week...
Takeda Scores FDA Nod for Subcutaneous Vedolizumab to Treat Inflammatory Bowel Disease
The US Food and Drug Administration (FDA) has granted Takeda Pharmaceutical Company Limited (NYSE: TAK),...
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...
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...