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...
Product approvals
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...
MicroPort MedBot’s SkyWalker Robot Approved for Orthopedic Surgery by NMPA
Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that it has received marketing...
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:...
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)...
Tuodao Medical’s Percutaneous Puncture Surgery Robot NP100 Approved in China
China-based surgical robot developer Tuodao Medical Technology Co., Ltd has received marketing approval for its...
CSPC Pharmaceutical Group Receives NMPA Approval for Irinotecan Liposome Injection
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received market approval...
Genesis MedTech Receives Chinese Market Approval for Antibacterial Absorbable Sutures
Singapore-based medical device company Genesis MedTech has announced that it has received market approval in...
EMA Approves Astellas’ Xtandi for Non-Metastatic Hormone-Sensitive Prostate Cancer
The European Medicines Agency (EMA) has granted Japan-based Astellas (TYO: 4503) an indication extension approval...
Grand Pharmaceutical Receives NMPA Approval for Generic Carbaglu for Hyperammonemia Treatment
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that it has received marketing approval...
FDA Extends Pfizer’s Comirnaty Vaccine Indication for Omicron XBB.1.5 Variant
The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) an indication extension...
Lepu Medical Technology Receives NMPA Approval for MemoSorb Biodegradable PFO Occluder
China-based cardiovascular disease solutions provider Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) has announced...
Merck’s Keytruda Approved in China for MSI-H/dMMR Advanced Solid Tumors: A Biomarker-Driven Milestone
US pharmaceutical major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its programmed...
Luye Pharma’s Botawei Receives NMPA Approval for Breast Cancer Treatment
Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the...
CSPC Pharmaceutical’s Narlumosbart Approved by NMPA for Bone Giant Cell Tumors
CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its subsidiary, Shanghai JMT Biotechnology Co.,...
Acotec Scientific Holdings Receives Marketing Approvals for Vericor-14 Microcatheter in Japan and Thailand
China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced that it has received marketing approvals...
Harbin Gloria Pharmaceuticals’ Zimberelimab Receives NMPA Approval for Cervical Cancer Treatment
China-based Harbin Gloria Pharmaceuticals Co., Ltd (SHE: 002437) has announced that it has received market...
Hansoh Pharmaceutical Receives NMPA Approval for Generic Ofev (Nintedanib)
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that it has received marketing...
Chia Tai Tianqing’s Generic Entresto Approved by NMPA, Launch Expected in 2026
The National Medical Products Administration (NMPA) website has indicated that Chia Tai Tianqing’s generic version...