Novartis’s Kisqali Approved by EC for Adjuvant Treatment of High-Risk Early Breast Cancer
Swiss pharmaceutical company Novartis (NYSE: NVS) has announced that it has received marketing approval from...
Product approvals
Chia Tai Tianqing’s Benmelstobart Combo Approved by NMPA for Endometrial Cancer Treatment
China-based Chia Tai Tianqing has announced that the National Medical Products Administration (NMPA) has granted...
Sichuan Kelun-Biotech’s SKB264/MK-2870 Approved by NMPA for Triple Negative Breast Cancer
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a China-based biopharmaceutical company, has received market approval...
CORXEL’s Varenicline Nasal Spray Approved by NMPA for Dry Eye Treatment
Shanghai-based CORXEL, formerly known as Ji Xing Pharmaceuticals, supported by RTW Investments, has received approval...
Zymeworks and Jazz Pharmaceuticals’ Ziihera Gets Green Light for HER2+ BTC Treatment
Partners Zymeworks Inc. (NASDAQ: ZYME) and Jazz Pharmaceuticals, Inc. have received accelerated approval from the...
Acotec Scientific Holdings Receives NMPA Approval for Thrombus Aspiration Catheter Support Tube
China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced that it has received marketing approval...
MicroPort Scientific Corp.’s BonaFire Receives NMPA Approval as First Whole-Body MRI Safety Pacing Electrode Lead
Shanghai-based medical device giant MicroPort Scientific Corp. (HKG: 0853) has announced that it has received...
GSK’s Arexvy Receives MHLW Approval for Expanded RSV Indication in Japan
UK-based pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK) has announced that Japan’s Ministry of Health, Labour...
Bayer’s Nubeqa Files for FDA Approval in mHSPC
German pharmaceutical company Bayer AG (ETR: BAYN) has announced that the US Food and Drug...
China Grants Marketing Approval for MSD’s Welireg for von Hippel-Lindau Disease Tumors
China’s National Medical Products Administration has issued marketing approval for Merck, Sharp & Dohme’s (MSD;...
Easton Pharmaceutical Secures NMPA Approval for Generic Jakavi and Urocit-K
Chengdu-based Easton Pharmaceutical Co., Ltd (SHA: 688513) has announced that it has received separate marketing...
Medtronic Receives US Approval for InPen App with Missed Meal Dose Detection
US-Irish firm Medtronic (NYSE: MDT) has announced US market approval for its new InPen app,...
NMPA Approves Alpha Biopharma’s Zorifertinib for First-Line NSCLC Treatment with CNS Metastases
The National Medical Products Administration (NMPA) has granted approval to China-based Alpha Biopharma’s zorifertinib, commercially...
Pfizer’s Hympavzi Receives European Commission Approval for Hemophilia A and B
US pharmaceutical major Pfizer Inc. (NYSE: PFE) has announced that the European Commission (EC) has...
UCB’s Bimzelx Receives US FDA Approval for Moderate to Severe Hidradenitis Suppurativa
Belgium-based biopharmaceutical company UCB (FRA: UNC) has announced that the US Food and Drug Administration...
New Horizon Health Registers Three Medical Devices in Hong Kong’s Department of Health
Hangzhou-based New Horizon Health Ltd (HKG: 6606) has announced the successful registration of three of...
Biogen and Samsung Bioepis Win EC Approval for Opuviz Biosimilar in Europe
US-based Biogen Inc. (NASDAQ: BIIB) and South Korea’s Samsung Bioepis Co., Ltd. have jointly announced...
AbbVie’s Elahere Receives EC Approval for FRα-Positive Ovarian Cancer Treatment
US-based AbbVie (NYSE: ABBV) has announced the European Commission (EC) approval for its antibody drug...
Everest Medicines’ Nefecon Receives Full Approval from South Korea’s MFDS for IgAN Treatment
China-based Everest Medicines (HKG: 1952) has announced that it has received full approval from the...
Sandoz Receives EC Approval for Biosimilar to Eylea for Retinal Diseases
Switzerland-based pharmaceutical company Sandoz (SWX: SDZ) has announced that it has received marketing approval from...