Henlius Biotech’s HER2 Targeting Biosimilar Secures Thai and Philippine Approvals
Shanghai Henlius Biotech Inc., (HKG: 2696) a leading China-based biotech firm, has announced that its...
Product approvals
Sino Medical Sciences Gains Pakistani Nod for SC HONKYTONK and NC ROCKSTAR Catheters
Sino Medical Sciences Technology Inc., (SHA: 688108) a Chinese medical device company, has announced that...
Formosa Pharmaceuticals Secures FDA Nod for New Steroidal Eye Drug, Set to Launch via Eyenovia
Taiwan-based Formosa Pharmaceuticals (TPE: 6838) has received approval from the US Food and Drug Administration...
Sandoz Achieves FDA Milestone with Approval of First US Denosumab Biosimilars
The US Food and Drug Administration (FDA) has granted Sandoz (SWX: SDZ), a Switzerland-based pharmaceutical...
Pfizer’s Cibinqo Secures NMPA Approval for Expanded Use in Atopic Dermatitis
The National Medical Products Administration (NMPA) has released drug approval certificate delivery information that points...
Sino Medical Sciences Receives Hong Kong Approval for HT Supreme Drug-Eluting Stent System
Sino Medical Sciences Technology Inc., (SHA: 688108), a Chinese medical technology company, has announced that...
Hainan Poly Pharm Secures Tentative FDA Approval for Generic Version of UCB’s Briviact
Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it...
J&J’s Rybrevant Secures Full FDA Approval for NSCLC with EGFR Exon 20 Insertions
The US Food and Drug Administration (FDA) has granted Johnson & Johnson (J&J; NYSE: JNJ)...
CARsgen Therapeutics’ BCMA-targeted CAR-T Cell Therapy Approved by China’s NMPA
CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies...
Gilead’s Biktarvy Receives FDA Approval for Expanded HIV Treatment Indication
Gilead (NASDAQ: GILD), a leading US pharmaceutical company, has been granted an indication extension approval...
Alvotech Scores FDA Nod for Interchangeable High-Concentration Biosimilar to Humira
The US Food and Drug Administration (FDA) has granted approval to Iceland-based Alvotech’s (NASDAQ: ALVO)...
Takeda’s Recombinant Pig FVIII Drug for Acquired Hemophilia A Approved in China
The National Medical Products Administration (NMPA) website has indicated that Takeda (TYO: 4502)’s Obizur (susoctocog...
Rossum Robot’s Intelligent Surgical Robot for Trauma and Spinal Surgery Clears NMPA Approval
Rossum Robot, a Beijing-based developer of orthopedic surgical robots specializing in pelvic fracture procedures, has...
AstraZeneca’s Tagrisso Meets PFS Endpoint in Late-Stage NSCLC Trial and Expands FDA Approval
AstraZeneca (AZ; NASDAQ: AZN), a leading UK-based pharmaceutical company, has announced that a late-stage trial...
Pfizer’s Velsipity Approved by European Commission for Moderately to Severely Active Ulcerative Colitis
The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its S1P...
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...
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...