FDA Removes REMS Requirements for BCMA- and CD19-Targeted CAR-T Therapies
The U.S. Food and Drug Administration (FDA) last week announced the removal of Risk Evaluation...
ProFound Therapeutics and Novartis Forge Four-Year Partnership for Cardiovascular Drug Targets
US-based ProFound Therapeutics announced a four-year partnership with Swiss giant Novartis (NYSE: NVS) to discover...
Diagens Biotech’s AI Imaging Platform iMedImage Makes Hong Kong IPO Debut
China-based Hangzhou Diagens Biotechnology Co., Ltd. has filed for an initial public offering (IPO) with...
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,...
GenFleet Therapeutics Files for Hong Kong IPO Amid KRAS Inhibitor Success
China-based GenFleet Therapeutics (Shanghai) Inc. has submitted its initial public offering (IPO) application to the...
DK Medtech Partners with Mozarc Medical to Enhance Hemodialysis Access Solutions
Suzhou-based DK Medical Technology Co. Ltd., a developer of vascular intervention balloon products, has entered...
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...
Viatris Announces Positive Results in VEGA-3 Trial for MR-141 Presbyopia Treatment
US-based Viatris (NASDAQ: VTRS) announced positive topline results from the second pivotal Phase III VEGA-3...
Jenscare’s LuX-Valve Plus Shows Promising Results in Global TRINITY Study
Ningbo-based structural heart disease device maker Jenscare Scientific Co., Ltd (HKG: 9877) announced positive 30-day...
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),...
Mabwell Bioscience Partners With Calico Life Sciences on 9MW3811 Development
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) is set to enter into a licensing...
China Raises Subsidy for Basic Public Health Services, Targets Vulnerable Groups
China’s National Health Commission (NHC) released the “Notice on Improving Basic Public Health Services in...
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...
Novartis Completes Acquisition of Regulus Therapeutics for ADPKD Treatment
Swiss giant Novartis (NYSE: NVS) announced the completion of its acquisition of U.S.-based Regulus Therapeutics....
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...
Mabwell Bioscience Grants Qilu Pharma Exclusive Rights to Mailisheng in Greater China
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced a licensing agreement with compatriot firm...
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...