EMA Panel Recommends Brukinsa Tablet Formulation for Approval
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
Cancer
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)...
Immvira Bioscience Files for Hong Kong IPO to Advance Oncolytic Immunotherapy Pipeline
Shenzhen-based Immvira Bioscience Inc. has filed for an initial public offering (IPO) with the Hong...
Henlius Biotech Doses First Patient in Japanese Bridging Trial of Serplulimab for ES-SCLC
China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced the successful completion of first patient dosing...
BeOne Medicines Launches Ziihera for HER2-High Biliary Tract Cancer in China
China-based BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced the official commercial availability...
Medilink Therapeutics’ YL201 Wins FDA Breakthrough Therapy Designation for SCLC
Suzhou-based Medilink Therapeutics announced that it has received Breakthrough Therapy Designation (BTD) from the US...
FDA Approves AstraZeneca’s Datopotamab deruxtecan for EGFR-Mutated NSCLC
The US Food and Drug Administration (FDA) this week approved Datopotamab deruxtecan (Dato-DXd), a TROP-2-targeted...
TransThera Sciences’ Tinengotinib Gains FDA Fast Track for mCRPC Treatment
China-headquartered TransThera Sciences (Nanjing) Inc., (HKG: 2617), which listed in Hong Kong this week, announced...
Broncus Medical Wins NMPA Approval for BroncAblate RFA System Console
Shanghai and Hangzhou (China), and San Jose and Seattle (United States)-based Broncus Medical (HKG: 2216)...
Hengrui Pharmaceuticals Wins NMPA Approval for Six Novel Solid Tumor Drugs
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving clinical trial approvals from the...
J&J’s Darzalex SC Recommended by CHMP for High-Risk Smoldering Multiple Myeloma
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended...
Johnson & Johnson’s Imbruvica Secures CHMP Recommendation for Expanded MCL Use
US giant Johnson & Johnson (J&J, NYSE: JNJ) announced that the Committee for Medicinal Products...
Bayer’s Nubeqa Receives Positive CHMP Opinion for mHSPC Treatment
German pharmaceutical giant Bayer AG (ETR: BAYN) announced last week that the European Medicines Agency...
MSD Initiates IDeate-Prostate01 Phase III Trial of Ifinatamab Deruxtecan for mCRPC
Merck, Sharp & Dohme (MSD, NYSE: MRK) this week announced the first patient dosing in...
Fosun Pharma’s Fumaining Launches Clinically for Rare Disease Treatment in China
Shanghai-based Fosun Pharmaceutical (Group) Co., Ltd.’s (HKG: 2196, SHA: 600196) in-house developed Category 1 drug...
Suzhou Zelgen Gains NMPA Approval for ZG005 and ZG006 Combination Trial in Advanced Cancers
China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received clinical trial...
EpimAb Biotherapeutics Submits Hong Kong IPO Application as Biotech Expands
Shanghai-based biotech EpimAb Biotherapeutics, Inc. has submitted a main board listing application to the Hong...
Sinocelltech Gains NMPA Clearance for SCTB39-1 Clinical Study in Advanced Solid Tumors
China-based Sinocelltech Group Ltd (SHA: 688520) announced that it has received clearance from the National...
Pierre Fabre Acquires Global Rights to EGFR Inhibitors PFL-721 and PFL-241 from Antares Therapeutics
France-based Pierre Fabre Laboratories announced the acquisition of global rights to PFL-721 and PFL-241 from...
BioTroy Therapeutics Secures USD 28M in Series A Funding for CD3L1 Anti-Tumor Drug Development
Shanghai-based BioTroy Therapeutics, a cancer immunotherapy developer, has reportedly secured over RMB 200 million (USD...