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)...
Drug
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...
Junshi Biosciences’ Senaparib NDA Accepted by NMPA for Ovarian Cancer Maintenance Treatment
China’s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced that the New Drug Application (NDA)...
Jiangsu Kanion Pharmaceutical Gets NMPA Approval for SLE Clinical Trial with KYS202002A
Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557), a prominent China-based pharmaceutical company, has announced that...
Everest Medicines’ Nefecon NDA for IgAN Accepted for Review in Macao
China-based Everest Medicines (HKG: 1952) has announced that its New Drug Application (NDA) for Nefecon,...
Pfizer’s RSV Vaccine Abrysvo Receives European Commission Approval for Maternal Immunization
Pfizer (NYSE: PFE) has received registration approval from the European Commission (EC) for its respiratory...
FDA Approves Gilead’s Veklury for COVID-19 Treatment in Patients with Hepatic Impairment
The US Food and Drug Administration (FDA) has approved a new indication for Gilead’s (NASDAQ:...