BMS Secures FDA Approval for Updated Labels of Breyanzi and Abecma
US major Bristol-Myers Squibb (BMS; NYSE: BMY) announced that the US Food and Drug Administration...
Drug
UCB’s Fenfluramine Shows Positive Results in Phase III GEMZ Study for CDKL5 Deficiency Disorder
Belgium-based biopharma UCB (EBR: UCB) announced positive results from its Phase III GEMZ study, evaluating...
Pfizer’s Emblaveo Approved by China’s NMPA for Complex Infections
US giant Pfizer Inc., (NYSE: PFE) announced that it has received marketing approval from China’s...
Gilead’s Lenacapavir Approved in Hainan for HIV-1 Pre-Exposure Prophylaxis
US-based Gilead Sciences, Inc. (NASDAQ: GILD) announced that its HIV pre-exposure prophylaxis (PrEP) drug, lenacapavir,...
ACIP Recommends MSD’s Enflonsia for Infants Under 8 Months to Prevent RSV
US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) revealed that the Advisory Committee...
Innovent Biologics’ Mazdutide Gets NMPA Nod for Weight Management
China’s National Medical Products Administration (NMPA) has approved Innovent Biologics, Inc.’s (HKG: 1801) mazdutide (IBI362),...
Hua Dong Medicine’s HDM2020 Gains NMPA Approval for Clinical Trials
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received clinical trial approval...
Cutia Therapeutics’ Phase III Results for Lidocaine-Tetracaine Cream to be Presented at CSD Meeting
Cutia Therapeutics (HKG: 2487), a dermatology specialist, is set to present the Phase III clinical...
Sino Biopharmaceutical’s LM-108 Gains CDE BTD for Gastric Adenocarcinoma
Sino Biopharmaceutical Ltd (HKG: 1177) announced that it has obtained Breakthrough Therapy Designation (BTD) from...
Fosun Pharma’s Serplulimab Approved for ES-SCLC in the UK and India
Shanghai-based Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196, SHA: 600196) announced that its subsidiary Shanghai...
Sanofi’s Riliprubart Granted Orphan Drug Status for Antibody-Mediated Rejection Treatment
France-based major Sanofi (NASDAQ: SNY) has secured Orphan Drug Designation (ODD) from the US Food...
Bio-Thera Solutions Initiates Phase III Trial of BAT8006 for Platinum-Resistant Ovarian Cancer
Guangzhou-based Bio-Thera Solutions (SHA: 688177) announced the successful first patient dosing in its Phase III...
EMA Panel Recommends Brukinsa Tablet Formulation for Approval
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
Sinocelltech Wins NMPA Clearance for TriAb SCTB39G in Solid Tumors
China-based Sinocelltech Group Ltd (SHA: 688520) announced that it has received clearance from the National...
CARsgen’s Satri-cel NDA Accepted by China’s NMPA for Gastric Adenocarcinoma
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that the National Medical Products Administration (NMPA)...
Lepu Biopharma Gains EMA Approval for MRG003 HNSCC Clinical Trial
China-based Lepu Biopharma Co., Ltd (HKG: 2157) announced that it has received approval from the...
Angel Pharma Gains NMPA Approval for Soquelitinib in Atopic Dermatitis Trial
China-based Angel Pharmaceuticals Ltd announced that it has received approval from the National Medical Products...
Biogen’s Phase I Results Highlight Salanersen’s Potential in Spinal Muscular Atrophy
Biogen (NASDAQ: BIIB) announced this week topline results from the Phase I study of salanersen...
Kymera and Sanofi Advance IRAK4 Program With Selection of KT-485 for Clinical Development
US-based Kymera Therapeutics Inc. (NASDAQ: KYMR) announced updates to its IRAK4-targeted program collaboration with Sanofi....
LG Chem’s Cross-Linked Sodium Hyaluronate Gel Gains NMPA Approval for Midface Use
South Korea’s LG Chem announced that its cross-linked sodium hyaluronate gel with lidocaine has received...