FDA Authorizes Biweekly Dosing for J&J’s Tecvayli in Multiple Myeloma Treatment
The US Food and Drug Administration (FDA) has granted authorization for a biweekly dosing regimen...
Product approvals
Innovent Biologics’ Tyvyt Receives Marketing Approval for Multiple Indications in Macau
Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has announced that...
Zylox-Tonbridge Receives UAE Approval for Five Medical Devices, Expands Middle East Presence
Zylox-Tonbridge (HKG: 2190), a Chinese specialist in medical devices, has announced a series of product...
WuXi ATU’s Philadelphia Facility Approved for Amtagvi Production Following FDA Nod
WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec (SHA: 603259, HKG:...
Hainan Poly Pharm Wins FDA Nod for Generic Version of UCB’s Vimpat
Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it...
FDA Approves Takeda’s Eohilia as First Oral Therapy for Eosinophilic Esophagitis in Patients Aged 11 and Up
The U.S. Food and Drug Administration (FDA) has granted approval to Takeda Pharmaceutical Company (TYO:...
Roche’s Piasky (Crovalimab) Secures NMPA Approval for Untreated Paroxysmal Nocturnal Hemoglobinuria
The National Medical Products Administration (NMPA) has granted marketing approval to Swiss pharmaceutical giant Roche...
MSD’s Keytruda Secures 13th Indication Approval in China for Biliary Carcinoma Treatment
Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading US pharmaceutical company, has announced that...
Peijia Medical’s Taurus Atlas Pro Balloon Dilation Catheter Approved by NMPA for Pulmonary Valve Procedures
Peijia Medical Ltd (HKG: 9996) has announced that it has received marketing approval from the...
MicroPort CRM Receives NMPA Approval for Next-Generation MRI-Safe Implantable Cardiac Pacing System
MicroPort Scientific Corp. (HKG: 0853), a leading Shanghai-based medical device company, has announced that its...
CSPC Pharmaceutical’s rhTNK-tPA Gets NMPA Approval for Acute Ischemic Stroke Treatment
CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced...
Biotech Pharmaceutical Secures Approval for Nimotuzumab in Head and Neck Cancer Treatment
Sino-Cuban joint venture Biotech Pharmaceutical Limited (BPL) has secured another indication approval in China for...
Jiangsu Hengrui Receives Chinese Approval for First Domestic Category 1 Opioid Analgesic for Postoperative Pain
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has proclaimed the receipt of marketing approval in...
Acotec Scientific’s Peridge Catheter Receives NMPA Nod for Hemodialysis Lesion Treatment
Acotec Scientific Holdings Ltd (HKG: 6669), a China-based medical device company, has announced that it...
Gilead’s Kite Subsidiary Reduces CAR T-Cell Therapy Turnaround Time with FDA Approval
Kite, a subsidiary of Gilead (NASDAQ: GILD), has announced a significant enhancement in the treatment...
Sandoz Launches Biosimilar Natalizumab in Germany, Challenging Biogen’s Tysabri
Sandoz, a division of Novartis and a leader in generic drugs and biosimilars headquartered in...
European Commission Approves Takeda’s Hyqvia for Chronic Inflammatory Demyelinating Polyneuropathy
The European Commission (EC) has granted regulatory approval to Takeda Pharmaceutical Company Limited (TYO: 4502)...
Hengrui Pharmaceuticals Scores First-Mover Status with FDA Approval for Generic Astagraf XL
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has...
Takeda’s Gammagard Liquid Approved by FDA for Chronic Inflammatory Demyelinating Polyneuropathy
The US Food and Drug Administration (FDA) has granted regulatory approval for Takeda’s (TYO: 4502)...
EMA’s CHMP Endorses Bristol Myers Squibb’s CAR-T Therapy Abecma for Multiple Myeloma
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...