Boehringer Ingelheim’s Survodutide Earns FDA Breakthrough Therapy Designation for MASH Treatment
German pharmaceutical company Boehringer Ingelheim has received breakthrough therapy designation (BTD) from the US Food...
Drug
Pfizer Halts Development of Sisunatovir, an RSV Antiviral, After Phase II/III Trials
U.S. pharmaceutical giant Pfizer (NYSE: PFE) has decided to discontinue the development of sisunatovir, an...
Biogen’s China Unit Gets Conditional NMPA Nod for Qalsody (Tofersen) in ALS Treatment
Biogen (NASDAQ: BIIB)’s Chinese subsidiary has announced that it has received conditional approval from the...
Joincare Pharmaceutical Secures NMPA Approval for Triptorelin Microspheres to Treat Endometriosis
China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) has announced that it has received...
CSPC Pharmaceutical Secures NMPA Approval for Omalizumab Biosimilar
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received marketing approval...
CSPC Pharmaceutical’s ADC CPO301 Earns Second Fast-Track Designation in the US for NSCLC Treatment
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its best-in-class antibody drug conjugate...
Bio-Thera Solutions Ltd Strikes Licensing Deal with Gedeon Richter for BAT1706 Biosimilar
Guangzhou-based Bio-Thera Solutions Ltd has announced a licensing agreement with Hungary’s Gedeon Richter Plc for...
Jiangsu Aidea Pharmaceutical Secures NMPA Approval for Expanded Indication of Fubangde in HIV Treatment
China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that the National Medical Products...
Ascentage Pharma Receives Approval for Two Phase III Trials of APG-2449 in NSCLC
China-based biopharmaceutical company Ascentage Pharma (HKG: 6855) has announced that it has received approval from...
China’s CDE Announces “Care Plan” to Include Pfizer’s Marstaximab for Rare Disease Drug Development
The National Health Commission (NHC) of China, through its Center for Drug Evaluation (CDE), has...
BeiGene Prices TEVIMBRA 10% Below Competitors Following FDA Approval for Esophageal Cancer Treatment
BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the commercial availability of TEVIMBRA (Tislelizumab)...
Unixell Advances in Cell Therapy with CDE IND Acceptance
Shanghai-based Unixell Biotechnology Co., Ltd. has announced that its Investigational New Drug (IND) application for...
Duality Biotherapeutics’ BDCA2 ADC DB-2304 Phase I Trial Registered on ClinicalTrials.gov
Duality Biologics, Inc., a biopharmaceutical company specializing in the development of innovative therapies, has registered...
BeiGene’s FGFR2b ADC BG-C137 Enters Phase I Clinical Trial for Advanced Solid Tumors
On October 3, 2024, BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) registered a Phase I...
BMS Expands Opdivo Indication with FDA Approval for NSCLC Combo Therapy
The U.S. Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS,...
InnoCare Pharma’s Orelabrutinib Achieves Milestone in SLE Clinical Trial Enrollment
InnoCare Pharma announced on October 4, 2024, that it has completed patient enrollment in a...
Akeso Biopharma’s PD-1/VEGF Bispecific Antibody Study Completes Enrollment
On October 4, 2024, Summit Therapeutics (referred to as “Summit”), a partner of Akeso Biopharma...
FRα ADC Rina-S by Genmab Enters Late-Stage Clinical Trial Following ProfoundBio Acquisition
Genmab A/S (NASDAQ: GMAB) has initiated a Phase III clinical trial for its FRα ADC...
Dizal Pharmaceutical’s Surufatinib Earns CDE Consideration for Breakthrough Therapy in EGFR exon20ins NSCLC
Dizal Pharmaceutical, a biopharmaceutical company based in China, has announced that the Center for Drug...
Hengrui Pharmaceuticals’ HR19042 Capsules Designated as Breakthrough Therapy for Autoimmune Hepatitis by China NMPA
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has recently...