Pfizer and BioNTech Receive Positive CHMP Opinion for Comirnaty Vaccine
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
Drug
Dizal Pharmaceutical’s Golidocitinib Earns Priority Review for r/r PTCL Treatment in China
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its drug golidocitinib has been...
AIM Vaccine Co., Ltd Launches Phase III Trial for 23-Valent Pneumococcal Vaccine
China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the commencement of a Phase III...
CSPC Pharmaceutical’s Biosimilar Ozempic Equivalent Gets NMPA Clinical Trial Approval
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its biosimilar version of Novo...
Jiangsu Yahong Meditech Gets NMPA Approval for APL1401 Ulcerative Colitis Trial
Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer based in...
Roche’s Evrysdi Receives EC Approval for Expanded Indication in Infants with SMA
Swiss pharmaceutical giant Roche (SWX: ROG) has received regulatory approval from the European Commission (EC)...
MSD’s Keytruda Gains EC Approval for First-Line HER2-Positive Gastric Cancer Treatment
The European Commission (EC) has granted an additional indication to Merck, Sharp & Dohme (MSD;...
BMS’ Reblozyl Expands Indication to Include First-Line MDS-Related Anemia Treatment
Bristol-Myers Squibb (BMS; NYSE: BMY) has received an indication extension approval from the US Food...
ImmunoTech Biopharm’s EAL Earns Breakthrough Therapy Designation for HCC Recurrence Prevention
The Center for Drug Evaluation (CDE) in China has indicated on its website that Immunotech...
Harbour BioMed’s HBM9033 ADC Receives US FDA IND Clearance for Clinical Trials
China-based Harbour BioMed (HKG: 2142) has announced receiving Investigational New Drug (IND) clearance from the...
Janssen Submits Indication Extension Application for Balversa in Urothelial Carcinoma Treatment
The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has submitted an indication extension...
Zhejiang Huahai Pharmaceutical Receives FDA Approval for Generic Vyvanse
Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced the receipt...
Boehringer Ingelheim Submits Three INDs for Survodutide Phase III Trials in China
Germany-based Boehringer Ingelheim (BI) has announced the submission of three Investigational New Drug (IND) filings...
Janssen Submits Rybrevant for FDA Review as First-Line NSCLC Treatment
Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has submitted an additional indication for review...
MSD Initiates Phase III Trial for PCSK9 Inhibitor MK-0616 in LDL Cholesterol Reduction
Merck, Sharp & Dohme (MSD; NYSE: MRK) has commenced Phase III development for its experimental...
Sandoz Receives FDA Clearance for First Biosimilar to Biogen’s Tysabri
The Sandoz unit of Switzerland-based Novartis (NYSE: NVS) has received regulatory clearance from the US...
Tasly Pharmaceuticals Gets NMPA Approval for STRO-002 Clinical Study in Solid Tumors
China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the National...
Youcare Pharmaceutical’s YKYYO17 Receives Ethical Approval for COVID-19 Treatment Study
China-based Youcare Pharmaceutical Group (SHA: 688658) has received ethical approval from the China-Japan Friendship Hospital...
Novartis Defends Entresto Patents as Generic Approvals Trigger Legal Response
On August 24, 2023, generic versions of Novartis’ (NYSE: NVS) heart failure therapy Entresto (sacubitril,...
Jiangsu Hengrui Submits Market Approval Filing for SHR0302 in Ankylosing Spondylitis
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that a market approval filing...