FDA Grants Priority Review to Pfizer and Astellas’ Xtandi for High-Risk Prostate Cancer
The US Food and Drug Administration (FDA) has granted priority review status to the submission...
Drug
Nanjing F&S Pharmatech Secures First Generic Approval for Novartis’s Entresto in China
Nanjing F&S Pharmatech Co., Ltd, a China-based pharmaceutical company, has announced that it has received...
Lynk Pharmaceuticals’ LNK01001 Shows Positive Results in Ankylosing Spondylitis Phase II Study
China-based Lynk Pharmaceuticals Co., Ltd has announced positive topline results from the Phase II clinical...
Allist Pharmaceuticals’ Furmonertinib Wins NMPA Nod for EGFR-Mutated NSCLC Treatment
Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) has announced that it has received clinical approval from...
Zai Lab’s Repotrectinib Targets Breakthrough Therapy Designation for TRK-Positive Tumors
The Center for Drug Evaluation (CDE) website has indicated that repotrectinib, a next-generation ROS1/TRK/ALK tyrosine...
RemeGen’s Telitacicept Shows Positive Phase III Results in Rheumatoid Arthritis Study
China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has announced positive results from the China...
Roche Subsidiary Genentech Addresses Accidental Disclosure of Tiragolumab Trial Data
Swiss pharmaceutical major Roche (SWX: ROG), through its subsidiary Genentech, has released a statement addressing...
European Commission Grants Conditional Approval for Janssen’s Talvey in Multiple Myeloma
The European Commission (EC) has granted conditional approval to Johnson & Johnson’s (J&J; NYSE: JNJ)...
Jiangsu Hengrui Pharmaceuticals’ Fluzoparib Files for New Indication with China’s NMPA
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that the National Medical Products...
Kintor Pharmaceutical Completes Enrollment in Phase II Study of GT20029 for Androgenetic Alopecia
China-based Kintor Pharmaceutical Limited (HKG: 9939) has announced the completion of patient enrollment in a...
Novartis’s Leqvio (Inclisiran) Approved in China for Hypercholesterolemia Treatment
Swiss pharmaceutical giant Novartis (NYSE: NVS) has received approval from the National Medical Products Administration...
Novatim’s KQ-2003 and KY-0118 Advance with Clinical Trial Approvals in China
China-based cancer immunotherapy specialist Novatim Immune Therapeutics (Zhejiang) Co., Ltd has recently obtained clinical trial...
Sichuan Huiyu Pharmaceutical’s Plerixafor Gains Marketing Approval from Italian Medicines Agency
Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that it...
Hainan Huluwa Pharmaceutical Gets NMPA Approval for Generic Briviact Clinical Study
China-based Hainan Huluwa Pharmaceutical Group Co., Ltd (SHA: 605199) has announced that it has received...
Luye Pharma Group Submits Market Approval Filing for Lurbinectedin in Metastatic SCLC in Macau
China-based Luye Pharma Group (HKG: 2186) has announced that a market approval filing has been...
Auzone Biological Technology Gets FDA Approval for Edaravone Oral Preparations in ALS
Suzhou Auzone Biological Technology Co., Ltd. has received approval from the US Food and Drug...
Gilead’s Magrolimab Phase III Trial for AML Faces Partial Hold by FDA
Gilead (NASDAQ: GILD) has announced that the US Food and Drug Administration (FDA) has imposed...
Pfizer’s RSV Vaccine Abrysvo Receives FDA Authorization for Maternal Immunization
The US Food and Drug Administration (FDA) has authorized the use of Pfizer’s (NYSE: PFE)...
J&J’s Teclistamab Granted Priority Review in China for Relapsed Multiple Myeloma
The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson’s (J&J, NYSE:...
Amgen’s Lumakras Faces Full Registration Review by FDA for KRAS-Mutated NSCLC
The US Food and Drug Administration (FDA) is scheduled to review an application submitted by...