OnCusp Therapeutics’ CUSP06 Receives FDA Fast Track for Ovarian Cancer
Sino-US company OnCusp Therapeutics Inc. has announced that it has received Fast Track Designation (FTD)...
Drug
Boao Airport Customs Releases First Batch of Modulen IBD for Crohn’s Disease Management
The Boao Airport Customs under Haikou Customs has released the first batch of 96 pieces...
Astellas Pharma’s Izervay Gets FDA Approval for GA Treatment Without Dosing Limit
Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the US Food and Drug Administration...
Huadong Medicine’s Biosimilar SaiYueXin Seeks NMPA Approval for Crohn’s Disease
Huadong Medicine Co., Ltd (SHE: 000963) announced that another indication approval filing for its SaiYueXin,...
Bayer’s Acoramidis (Beyonttra) Gets EMA Marketing Approval for ATTR-CM Treatment in EU
Germany-headquartered Bayer (ETR: BAYN) has received marketing approval from the European Medicines Agency (EMA) for...
Livzon Pharmaceutical’s JP-1366 Approved for Peptic Ulcer Study by NMPA
China-based Livzon Pharmaceutical Group Inc. (HKG: 1513) has obtained approval from the National Medical Products...
Eli Lilly Licenses OliX Pharma’s OLX75016 for MASH and Cardiometabolic Diseases
Eli Lilly & Co. (NYSE: LLY) has signed a licensing agreement with OliX Pharmaceuticals, Inc....
Lion TCR’s Liocyx-M00 Therapy Receives FDA Clearance for HBV-Related HCC Study
Singapore-based clinical-stage biotechnology company Lion TCR, backed by Chinese investors, has received clearance from the...
Hainan Poly Pharm’s Generic ProHance Wins FDA Approval in US
China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) announced that the US Food and Drug...
J&J’s Rybrevant and Talvey Win Separate NMPA Approvals in China
US pharma giant Johnson & Johnson (J&J, NYSE: JNJ) announced receiving marketing approvals from China’s...
Degron Therapeutics’ DEG6498 Receives FDA Clearance for Clinical Trials
China-based Degron Therapeutics, a developer of molecular glue-based drugs, announced that the U.S. Food and...
Bio-Thera Solutions’ BAT1006 Wins NMPA Approval for HER2+ Breast Cancer Trial
China’s Bio-Thera Solutions Ltd (SHA: 688177) has received clinical trial approval from the National Medical...
China Resources Double-Crane Pharmaceutical Co., Ltd Receives NMPA Approval for Generic Purinethol
China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) announced that it has received marketing approval...
Henlius Biotech’s HLX99 Receives FDA Approval for ALS Clinical Study
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the U.S. Food and Drug Administration (FDA)...
Henlius Biotech Doses First Patient in HLX43 Phase II Study for Esophageal Cancer
Shanghai Henlius Biotech Inc. (HKG: 2696) announced the first patient dosing in a Phase II...
Bayer Files for Eylea 8 mg EMA Approval to Extend AMD, DME Treatment Intervals
Bayer (ETR: BAYN) has submitted a marketing application to the European Medicines Agency (EMA) for...
Bristol-Myers Squibb’s Breyanzi Hits Primary Endpoint in Lymphoma Study
Bristol-Myers Squibb (BMS, NYSE: BMY) reported positive results from the Phase II TRANSCEND FL study...
CSPC Pharmaceutical’s SYH2039 Wins FDA Clinical Approval for Advanced Tumors
China’s CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that the U.S. Food and Drug Administration...
Boehringer Ingelheim’s Nerandomilast Hits Primary Endpoint in PPF Phase III Study
German pharma giant Boehringer Ingelheim announced positive topline results from the Phase III FIBRONEER-ILD study...
CSPC Pharmaceutical’s Omalizumab Biosimilar Wins NMPA Approval for Allergic Asthma
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has received an additional indication approval from the...