Viatris Inc. Secures FDA Nod for Generic Symbicort Equivalent, Breyna
US-based Viatris Inc., (NASDAQ: VTRS) has announced that the US Food and Drug Administration (FDA)...
Product approvals
MicroPort MedBot’s SkyWalker Orthopedic Surgery Robot Gains TGA Approval in Australia
Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that it has received marketing...
Shanghai Benemae’s Benaglutide Approved by NMPA for Adult Weight Management in China
The National Medical Products Administration (NMPA) has indicated on its website that benaglutide, developed by...
Sino Biopharmaceutical Receives NMPA Approval for Biosimilar Herceptin for HER2+ Cancers
Sino Biopharmaceutical Ltd (HKG: 1177) has announced that it has received market approval from the...
SSY Group Ltd Receives NMPA Approval for Stiripentol Dry Suspension for Dravet Syndrome
China-based SSY Group Ltd (HKG: 2005) has announced that it has received marketing approval from...
Boehringer Ingelheim and Eli Lilly’s Jardiance Approved by EC for Chronic Kidney Disease
Germany-based Boehringer Ingelheim and its US partner Eli Lilly & Co., (NYSE: LLY), have reported...
FDA Approves Daiichi Sankyo’s Vanflyta for FLT3-ITD Positive AML Maintenance Treatment
The US Food and Drug Administration (FDA) has granted clearance to Japan-based Daiichi Sankyo (TYO:...
AbbVie’s Aquipta and Novartis’s Piqray Receive Regulatory Approvals in Mexico
Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) has granted registration approvals to two...
Janssen’s Sirturo (Bedaquiline) Expands Indication to Include Adolescents with MDR-TB
The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has announced that the National...
Sanofi and AstraZeneca Receive FDA Approval for RSV Prevention Treatment Beyfortus
France-based Sanofi (NASDAQ: SNY) has announced that it, along with AstraZeneca (AZ; NASDAQ: AZN), has...
Antengene Corp., Ltd Receives Hong Kong NDA Approval for Xpovio in Relapsed Multiple Myeloma
China-based biopharmaceutical company Antengene Corp., Ltd (HKG: 6996) has announced receiving New Drug Application (NDA)...
GSK’s Cabotegravir Receives NMPA Approval for HIV Treatment in China
The National Medical Products Administration (NMPA) has granted marketing approval for GlaxoSmithKline’s (GSK, NYSE: GSK)...
Beijing Tinavi Medical’s Knee Replacement Navigation System Approved by NMPA
Beijing Tinavi Medical Technologies Co., Ltd (SHA: 688277) has received marketing approval from the National...
Sino Medical Sciences Receives Approval for Next-Generation Drug-Eluting Stent in Indonesia
China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced receiving market approval for its...
Peijia Medical Receives NMPA Approval for DCwire Micro Guide Wire Device in China
Peijia Medical Ltd (HKG: 9996), a leading Chinese firm in the neurointerventional field, has announced...
3SBio Inc. Receives NMPA Approval for Nalfurafine Tablets to Treat Hemodialysis-Related Pruritus
China-based 3SBio Inc. (HKG: 1530) has announced receiving marketing approval from the National Medical Products...
AbbVie’s Rinvoq Receives NMPA Approval for Moderate to Severe Crohn’s Disease Treatment
US pharmaceutical firm AbbVie (NYSE: ABBV) has announced receiving market approval from the National Medical...
Luye Pharma’s Goserelin Acetate Microspheres Approved by NMPA for Prostate Cancer Treatment
Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the...
Huadong Medicine’s Liraglutide Biosimilar Gains NMPA Approval for Weight Loss Indication
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received additional indication...
NMPA Approves Pitolisant for Narcolepsy-Related Excessive Daytime Drowsiness and Cataplexy
The National Medical Products Administration (NMPA) has approved pitolisant as a treatment for excessive daytime...