Sanofi’s Gene Therapy SAR446597 Secures FDA Fast Track for Geographic Atrophy
France-based Sanofi (NASDAQ: SNY) announced that its one-time intravitreal gene therapy SAR446597 has received FDA...
Product approvals
Shanghai Sanyou Medical Receives NMPA Marketing License for JAZZ Spinal Fixation System
Shanghai Sanyou Medical Co., Ltd (SHA: 688085) announced that it has received the marketing license...
Vigonvita’s Simenafil Receives NMPA Approval for Erectile Dysfunction Treatment
Suzhou-based Vigonvita Life Sciences Co., Ltd., announced that it has received marketing approval from the...
Bayer AG’s Kerendia Approved by FDA to Treat Adult Heart Failure with Ejection Fraction ≥40%
German pharmaceutical giant Bayer AG (ETR: BAYN) announced that it has received marketing approval from...
Bayer’s Elinzanetant Granted UK Marketing Authorization for Menopause-Related Vasomotor Symptoms
Germany’s Bayer (ETR: BAYN) this week announced that the UK Medicines and Healthcare products Regulatory...
BeOne Medicines’ Tevimbra Approved by European Commission for Nasopharyngeal Carcinoma
China-based BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that it has received...
Johnson & Johnson MedTech Launches VARIPULSE Platform for Atrial Fibrillation in Asia-Pacific
US major Johnson & Johnson MedTech announced the launch of its VARIPULSE Platform in the...
Zelgen’s ZG006 Receives Breakthrough Therapy Designation for Advanced Small Cell Lung Cancer
China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received breakthrough therapy...
Ascentage Pharma’s Lisaftoclax Receives NMPA Approval for CLL/SLL Treatment
China-based Ascentage Pharma (NASDAQ: AAPG, HKG: 6855) announced that it has received conditional marketing approval...
CStone Pharmaceuticals Receives NMPA Approval for Local Production of Gavreto in China
China-based CStone Pharmaceuticals (HKG: 2616) has announced that it has received approval from the National...
Eli Lilly’s Kisunla (Donanemab) Receives FDA Label Update with New Dosing Schedule for Alzheimer’s Treatment
US pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) has announced that the US Food...
Innovent’s Dabote Becomes First China-Originated KRAS G12C Inhibitor Approved in Macau
China-based biopharma leader Innovent Biologics Inc. (HKG: 1801) has announced a significant regulatory milestone with...
Novartis’ Coartem Baby Approved by Swissmedic for Newborns and Young Infants
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that it has received marketing approval from Swissmedic...
Boston Scientific’s FARAPULSE Gains FDA Approval for Expanded Use in Persistent Atrial Fibrillation
US-based Boston Scientific Corporation (NYSE: BSX) announced that it has received US FDA approval for...
Grand Pharma’s SIR-Spheres Y-90 Gets FDA Accelerated Approval for Unresectable HCC
China-based Grand Pharmaceutical Group Limited (HKG: 0512) announced that SIR-Spheres Y-90 resin microspheres (SIR-Spheres), a...
AstraZeneca’s Imfinzi Approved in EU for Perioperative Treatment of Muscle-Invasive Bladder Cancer
UK-based AstraZeneca (AZ, NASDAQ: AZN) announced that it has received marketing approval in the European...
Eli Lilly’s Mounjaro Approved by China’s NMPA for Obstructive Sleep Apnea in Obese Adults
US pharma giant Eli Lilly & Co. (NYSE: LLY) announced that it has received a...
Sino Biopharmaceutical’s Recombinant Factor VIIa N01 Approved by NMPA for Hemophilia Treatment
China’s Sino Biopharmaceutical Ltd (HKG: 1177) announced that it has received marketing approval from the...
Thermo Fisher’s Oncomine Dx Express Test Approved by FDA as Companion Diagnostic for Dizal’s Zegfrovy
US-based Thermo Fisher Scientific Inc. (NYSE: TMO) announced that it has received marketing approval from...
Jiangsu Hengrui Announces NMPA Approval for Miebo in Dry Eye Disease Treatment
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received marketing approval...