Merck’s Keytruda Under Priority Review for New Indication in Endometrial Carcinoma
This week, the U.S. FDA granted priority review status to an indication extension filing from...
Drug
Mabwell Bioscience Receives FDA Green Light for B7-H3 Targeting ADC 7MW3711
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced...
Jacobio Pharma Gets CDE Green Light for Phase III Study Combining Gleevec Inhibitors in NSCLC
Jacobio Pharma (HKG: 1167), a China-based pharmaceutical company, has announced that it has received approval...
Neurophth Biotechnology Completes Enrollment and Dosing in US Clinical Study for ND4-LHON Gene Therapy
Neurophth Biotechnology Ltd, a leading gene therapy specialist based in China, has announced the completion...
Phanes Therapeutics’ PT886 Receives CDE Approval for Clinical Trials in Advanced Solid Tumors
Sino-US biotechnology company Phanes Therapeutics Inc. has announced that it has received clinical trial approval...
ImmunoTech Biopharm Gets NMPA Green Light for Clinical Study of aT19 Injection for B-ALL
ImmunoTech Biopharm Ltd (HKG: 6978), a specialist in chimeric antigen receptor T-cell (CAR-T) therapies based...
AstraZeneca’s Tagrisso Wins Expanded FDA Approval for EGFR-mutated NSCLC
UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has received a new indication approval from the...
Innovent Biologics’ IBI311 Achieves Primary Endpoint in Phase III Study for Thyroid Eye Disease
Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced that its...
Denali Therapeutics Faces Setback as ALS Trial Fails to Meet Primary Endpoint
Denali Therapeutics (NASDAQ: DNLI) has announced disappointing results from a Phase II trial of its...
Hainan Poly Pharm Wins FDA Nod for Generic Version of UCB’s Vimpat
Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it...
Roche’s Xolair Gains FDA Approval to Combat IgE-Mediated Food Allergies in Patients Aged 1 and Up
Roche (SWX: ROG) has announced that the U.S. Food and Drug Administration (FDA) has granted...
Ipsen Secures FDA Approval for Onivyde Regimen as First-Line Treatment for Metastatic Pancreatic Adenocarcinoma
Ipsen (EPA: IPN, OTCMKTS: IPSEY), the France-based biopharmaceutical company, has announced that the U.S. Food...
FDA Approves Takeda’s Eohilia as First Oral Therapy for Eosinophilic Esophagitis in Patients Aged 11 and Up
The U.S. Food and Drug Administration (FDA) has granted approval to Takeda Pharmaceutical Company (TYO:...
Roche’s Piasky (Crovalimab) Secures NMPA Approval for Untreated Paroxysmal Nocturnal Hemoglobinuria
The National Medical Products Administration (NMPA) has granted marketing approval to Swiss pharmaceutical giant Roche...
Roche Secures NMPA Approval for Rozlytrek to Treat Pediatric NTRK Fusion-Positive Tumors
Swiss pharmaceutical giant Roche (SWX: ROG) has received a new indication approval from the National...
FDA Grants Priority Review for GSK’s Arexvy to Expand RSV Vaccine Age Range to 50-59
The U.S. Food and Drug Administration (FDA) has initiated a priority review of GlaxoSmithKline’s (GSK;...
CMS Secures NMPA Approval for Clinical Trials of TYK2 Inhibitor CMS-D001 and GnRH Antagonist CMS-D002
China Medical System Holdings Ltd (CMS, HKG: 0867) has announced that it has received clinical...
Evopoint Biosciences Enrolls First Patient in Phase III Trial for Gout Drug XNW3009
Suzhou-based Evopoint Biosciences Co., Ltd. has announced the enrollment of its first patient in a...
ChinaGene Secures CDE Approval for ZVS101e Gene Therapy Targeting Retinitis Pigmentosa
Beijing-based ChinaGene Technology Co., Ltd. has announced that it has received tacit clinical approval from...
Nanjing Zenshine’s ZX-7101A NDA Accepted by NMPA for Uncomplicated Influenza Treatment
Nanjing Zenshine Pharmaceuticals Co., Ltd., a China-based small molecule drug developer, has announced that the...