CDE Grants Priority Review to Jiu An’s Adrenaline and AnHeart’s Taletrectinib; Two Others Earn Breakthrough Therapy Designation
The Center for Drug Evaluation (CDE) has announced that Jiu An Pharmaceutical’s adrenaline and AnHeart...
Drug
Huadong Medicine’s MaiLi Extreme Achieves Clinical Study Milestone for Chin Retraction Treatment
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that a Chinese clinical study for...
CARsgen Therapeutics’ BCMA-targeted CAR-T Cell Therapy Approved by China’s NMPA
CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies...
FDA Withdraws Approval for Multiple Myeloma Drug Pepaxto Over Safety and Efficacy Concerns
The US Food and Drug Administration (FDA) has announced its final decision to withdraw approval...
Chia Tai Tianqing’s Anlotinib-Benmelstobart Combo Therapy Receives CDE Review for Endometrial Cancer
Chia Tai Tianqing, a renowned biopharmaceutical company based in China, has announced that the Center...
CanSino Biologics’ 13-Valent Pneumococcal Vaccine CRM197 Accepted for NMPA Review
CanSino Biologics Inc., (HKG: 6185), a leading Chinese biopharmaceutical company, has announced that the National...
AstraZeneca’s AZD0486 Receives NMPA Greenlight for Clinical Study in B-Cell Leukemia
AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, has received approval from the National Medical...
BMS’s Azacitidine, First Oral AML Therapy, Reaches GBA Patients via Special Policy
Bristol-Myers Squibb (BMS, NYSE: BMY), a leading US pharmaceutical company, has announced the clinical application...
Abbisko Therapeutics Reports Positive Phase I Results for ABSK061 in Solid Tumors at ESMO TAT 2024
Shanghai-based Abbisko Therapeutics Co., Ltd. (HKG: 2256) has revealed promising outcomes from a global, multi-center...
Cutia Therapeutic’s CU-20401 Shows Promising Safety and Efficacy in Phase I Abdominal Fat Reduction Study
Cutia Therapeutic (HKG: 2487), a China-based dermatology specialist, has announced the successful completion of a...
Shandong Buchang Pharmaceuticals Gets NMPA Greenlight for Phase I Study of BC001 in Solid Tumors
Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a Chinese pharmaceutical company, has announced that it...
Bayer’s BAY 2927088 Receives FDA Breakthrough Therapy Designation for HER2-Mutated NSCLC
The US Food and Drug Administration (FDA) has granted Germany-based Bayer AG (ETR: BAYN) breakthrough...
Haisco Pharmaceutical Gets NMPA Greenlight for HSK39775 Solid Tumor Drug Candidate
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a Chinese pharmaceutical company, has announced that it...
Gilead’s Biktarvy Receives FDA Approval for Expanded HIV Treatment Indication
Gilead (NASDAQ: GILD), a leading US pharmaceutical company, has been granted an indication extension approval...
AstraZeneca’s Fasenra Matches Nucala in EGPA Trial and Shows Steroid Reduction Benefits
UK pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has presented results from a Phase III trial...
BeiGene’s Tislelizumab Receives CHMP Recommendation for Three NSCLC Indications in Europe
BeiGene (NASDAQ: BGNE) has announced that the European Medicines Agency’s Committee for Medicinal Products for...
Everest Medicines Gets CDE Approval for Global Phase IIb Study of Zetomipzomib in Lupus Nephritis
Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that it has received approval...
Alvotech Scores FDA Nod for Interchangeable High-Concentration Biosimilar to Humira
The US Food and Drug Administration (FDA) has granted approval to Iceland-based Alvotech’s (NASDAQ: ALVO)...
Kelun-Biotech Launches Clinical Trials for SKB264, Triggering $75 Million Milestone Payment from MSD
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) has announced the initiation of clinical trials for...
AstraZeneca Launches Phase I Trial for siRNA Therapy in Collaboration with Silence Therapeutics
AstraZeneca (AZ; NASDAQ: AZN) has commenced a Phase I trial for a short interfering RNA...