Health Archive

CSOFT’s health sciences blog aims to provide a better understanding of complex diseases, and regulatory polices from conducting experiments to introducing new type of drugs into the market.

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FDA Approves Amgen’s Lumakras for Lung Cancer Mutation

FDA Approves Amgen’s Lumakras for Lung Cancer Mutation

The U.S. Food and Drug Administration (FDA) has given Amgen’s Lumakras (sotorasib) accelerated approval as a treatment for patients diagnosed with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) - the first FDA approved treatment...

Fennec Pharmaceuticals Resubmits NDA for PEDMARK™

Fennec Pharmaceuticals Resubmits NDA for PEDMARK™

Fennec Pharmaceuticals has resubmitted their New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PEDMARK™, a unique sodium thiosulfate formulation. PEDMARK is designed to prevent ototoxicity caused by cisplatin chemotherapy in patients under...

FDA Places Restrictions for Obeticholic Acid (Ocaliva)

FDA Places Restrictions for Obeticholic Acid (Ocaliva)

The U.S. Food and Drug Administration (FDA) has placed restrictions on the use of obeticholic acid (Ocaliva of Intercept Pharmaceuticals) in patients with primary biliary cholangitis (PBC) and advanced cirrhosis due to risk for serious liver injury. The restriction...

Belgium Suspends J&J Vaccine

Belgium Suspends J&J Vaccine

The Johnson & Johnson COVID-19 vaccine has been suspended in Belgium for individuals under the age of 41 after the first reported death in the European Union linked to severe side effects associated with the shot. The European Medicines Agency (EMA) is currently...

COVID-19 Vaccine of CanSinoBIO Receives European GMP

COVID-19 Vaccine of CanSinoBIO Receives European GMP

CanSinoBIO announced today that the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI) has granted Good Manufacturing Practices (GMP) certification for its COVID-19 vaccine, Convidecia™. Dr. Xuefeng YU, Chairman and Chief Executive Officer of CanSinoBIO,...

FDA Clears Overjet’s AI Dental Assist

FDA Clears Overjet’s AI Dental Assist

The U.S. Food and Drug Administration (FDA) has cleared Overjet's AI Dental Assist product, marking it the first AI technology to enter the dental industry to aid dental hygienists and dentists in real time. The SaMD (Software as a Medical Device) will support the...

Industry-First At-Home HPV Screening Has Been CE Marked

Industry-First At-Home HPV Screening Has Been CE Marked

BD (Becton, Dickinson, and Company) announced today the first self-collection, at-home HPV screening has been CE marked to the IVD directive 98/79/EC. With this new claim, diagnostic labs will now be able to process the self-collected vaginal samples using the BD...

FDA Grants IDE to ZOLL Medical for ISO Shock Study

FDA Grants IDE to ZOLL Medical for ISO Shock Study

The U.S. Food and Drug Administration (FDA) has granted ZOLL Medical investigational device exemption (IDE) for a randomized study to evaluate TherOx® SuperSaturated Oxygen (SSO2) Therapy in patients with cardiogenic shock and ST Elevation Myocardial Infarction...

New Contact Lenses for Children to Slow Myopia Progression

New Contact Lenses for Children to Slow Myopia Progression

Eyepic Eye Care announced a revolutionary service using the only FDA-approved MiSight multifocal contact lenses meant to slow myopia progression in children. Myopia, which is a refractive eye condition causing nearsightedness, affects approximately 40% of Americans...

FDA Clears ConforMIS, Inc.’s Knee Replacement System

FDA Clears ConforMIS, Inc.’s Knee Replacement System

The U.S. Food and Drug Administration (FDA) has granted ConforMIS Inc. 510(k) clearance for its Identity Imprint™ Knee Replacement System. Available in both posterior stabilized (PS) and cruciate retaining (CR) versions, the system expands the range of options for...

NMPA Approves PARP Inhibitor Pamiparib of BeiGene

NMPA Approves PARP Inhibitor Pamiparib of BeiGene

China's regulatory body, the National Medical Products Administration (NMPA), has granted conditional approval to BeiGene's PARP inhibitor pamiparib for treatment of patients advanced ovarian cancer. The approval marks the first for pamiparib and the third for...