Johnson & Johnson Submits sBLAs to FDA for Tremfya Indications in Pediatric Psoriasis and Arthritis
Global healthcare giant Johnson & Johnson (J&J; NYSE: JNJ) has announced the submission of two...
Drug
Merus N.V. Receives FDA Approval for Bizengri for NRG1+ Pancreatic and Lung Cancers
Holland-based Merus N.V. (NASDAQ: MRUS) has announced that it has received FDA approval for its...
Ipsen’s Bylvay Receives NMPA Clearance for Treating Itching in PFIC Patients in China
France-based Ipsen (EPA: IPN) has announced that it has received marketing clearance from the National...
Tasly Pharma Receives NMPA Approval for Generic Lioresal (Baclofen) Oral Solution
China-based Tasly Pharma Co., Ltd (SHA: 600535) has announced that it has received marketing approval...
Humanwell Healthcare’s Recombinant Plasmid Hepatocyte Growth Factor Injection Accepted for NMPA Review
China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced that the National Medical Products...
Haisco Pharmaceutical’s HSK46575 Receives NMPA Approval for Prostate Cancer Clinical Trial
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced the receipt of clinical trial...
Sichuan Kelun-Biotech’s SKB500 Receives NMPA Clinical Clearance for Solid Tumor Treatment
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd, (HKG: 6990), a leading biopharmaceutical company based in China, has...
Cinclus Pharma’s Linaprazan for GERD Receives NMPA Marketing Approval
Sweden-based Cinclus Pharma has announced that it has received marketing approval from the National Medical...
Shanghai Henlius Biotech’s HLX11 Biosimilar Accepted for Review by China’s CDE
Shanghai Henlius Biotech Inc. (HKG: 2696), a leading biopharmaceutical company based in China, has announced...
Shanghai Henlius Biotech’s HLX22 Receives NMPA Approval for Phase II HER2-Targeted Study
Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced...
GSK plc Enters Exclusive Option Agreement with Duality Biologics for ADC Candidate DB-1324
UK-based GSK plc (NYSE: GSK) has entered into an exclusive option agreement with Duality Biologics,...
Guangzhou Virotech’s Oncolytic Virus M1 Receives Tacit Clinical Approval from NMPA
Guangzhou Virotech Pharmaceutical Co., Ltd., a China-based pharmaceutical company, has announced receiving tacit clinical approval...
Ipsen Secures Global Licensing Agreement for Biomunex Pharmaceuticals’ BMX-502 T Cell Engager
France-based Ipsen (OTCMKTS: IPSEY) has announced a significant global licensing agreement with compatriot firm Biomunex...
OncoC4, Inc. Receives FDA Clearance for AI-081, a PD-1 and VEGF Bispecific Antibody
US-based OncoC4, Inc. has announced that it has received clinical clearance from the US Food...
Luye Pharma’s Zepzelca Receives NMPA Approval for Metastatic Small Cell Lung Cancer Treatment
China-based Luye Pharma Group (HKG: 2186) has announced that it has received marketing approval from...
Sacituzumab Tirumotecan Earns FDA Breakthrough Therapy Designation for EGFR Mutated NSCLC
Sacituzumab tirumotecan (SKB264/MK-2870), a TROP2-targeted antibody drug conjugate (ADC) co-developed by Merck, Sharp & Dohme...
Merck’s Recarbrio Approved by NMPA for Hospital-Acquired Infections and Complicated UTIs
US pharmaceutical major Merck, Sharp & Dohme Inc., (MSD; NYSE: MRK) has announced that it...
Abbisko Therapeutics Gets FDA Green Light for Phase I Study of ABSK131 Inhibitor
Shanghai-based biotech company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received...
Hefan Medicine’s Piracetam Production and Marketing Suspended Over GMP Violations
The National Drug Alliance Procurement Office has issued a notification to suspend the manufacturing and...
InventisBio’s Oral TYK2 Inhibitor D-2570 Achieves Positive Results in Phase II Psoriasis Study
China-based InventisBio (Shanghai) Co., Ltd (SHA: 688382) has announced the successful completion of a Phase...