GSK’s Ojjaara Approved by FDA for Anemic Myelofibrosis Patients
The US Food and Drug Administration (FDA) has granted regulatory approval to GlaxoSmithKline (GSK; NYSE:...
Drug
BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal
China-based biotech company BeiGene (NASDAQ: BGNE) has reached a mutual agreement with Novartis (NYSE: NVS)...
Jiangsu Hengrui Pharmaceuticals Wins NMPA Approval for Two Novel Drug Candidates
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced receiving...
Pfizer’s Cibinqo and Everest Medicines’ Cefepime-Taniborbactam Selected for Priority Reviews by CDE
The Center for Drug Evaluation (CDE) has indicated on its website that Pfizer’s (NYSE: PFE)...
EMA’s CHMP Supports Gilead’s Veklury for COVID-19 Patients with Hepatic Impairment
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recently...
FDA Grants Priority Review to MSD’s Welireg for Advanced RCC Indication Extension
The US Food and Drug Administration (FDA) has granted priority review status to an indication...
Astellas Pharma’s Xtandi NDA for mHSPC Treatment Accepted by China’s CDE
Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the Center for Drug Evaluation (CDE)...
Pfizer’s Litfulo Earns EU Approval as First Treatment for Severe Alopecia Areata in Teens
Pfizer (NYSE: PFE) has been granted registration authorization by the European Commission (EC) for Litfulo...
Walvax Biotechnology Receives Indonesian FDA Approval for Phase III Pneumococcal Vaccine Trial
China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced that it has received approval from...
Sunshine Guojian Pharmaceutical Gets NMPA Approval for SSGJ-611 Phase II COPD Study
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, (SHA: 688336) a subsidiary of 3SBio Inc. (HKG: 1530),...
AbbVie’s Allergan Aesthetics Secures NMPA Approval for Juvéderm VOLUMA with Lidocaine
Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced that it has received marketing...
Caliway Biopharmaceuticals’ CBL-514 Achieves Milestones in Dercum’s Disease Trial
Taiwan-based Caliway Biopharmaceuticals, a specialist in medical aesthetics and inflammatory medicine, has announced that its...
Zhejiang Medicine Gets NMPA Approval for NCB003 Clinical Study for Advanced Solid Tumors
Zhejiang Medicine Co., Ltd (SHA: 600216), a China-based pharmaceutical company, has announced that it has...
Zelgen Biopharmaceuticals’ rhTSH Achieves Primary Endpoint in Phase III Study
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a China-based pharmaceutical company, has announced that its...
CSBIO’s Albenatide Shows Positive Results in Two Phase III Diabetes Trials
Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255) has announced encouraging results from two...
Sandoz Receives Positive CHMP Review for Trastuzumab Biosimilar in HER2-Positive Cancers
Sandoz (SWX: SDZ), the generic and biosimilar drug maker set to separate from Novartis (NYSE:...
Gilead’s Kite CAR-T Therapy Yescarta Achieves 71% CMR in Phase II Trial for R/R LBCL Patients
Gilead’s (NASDAQ: GILD) subsidiary Kite has announced early results from a Phase II trial of...
EMA’s CHMP Backs Enhertu for Advanced NSCLC with HER2 Mutations
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
EMA’s CHMP Recommends Approval of Keytruda as Adjuvant NSCLC Treatment
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
Novartis’s Kisqali Reduces Cancer Recurrence Risk in HR+/HER2- Early Breast Cancer: Phase III Results
Swiss pharmaceutical giant Novartis (NYSE: NVS) has published results from a Phase III study of...