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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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Roche COVID-19 Molecular Test Granted EUA for PCR Testing

Roche COVID-19 Molecular Test Granted EUA for PCR Testing

The U.S. Food and Drug Administration (FDA) has granted Roche Emergency Use Authorization (EUA) for its PCR cobas® SARS-CoV-2 Nucleic acid test. The EUA was granted for use on the cobas® Liat® System, and is the first RT-PCR (reverse transcriptase polymerase chain...

FDA Grants Pre-Approval for IND for Potential HIV Cure

FDA Grants Pre-Approval for IND for Potential HIV Cure

The U.S. Food and Drug Administration (FDA) has granted pre-approval for Enochian BioSciences' Investigational New Drug (IND) application for a potential functional treatment or cure for HIV (human immunodeficiency disorder). The submission is based off of an...

Delta Variant: Likely More Than 6% of US COVID Cases

Delta Variant: Likely More Than 6% of US COVID Cases

Initially detected in India in December last year, the CDC has declared that the Delta variant (B.1.617.2.) can now be found in over 60 countries. The Delta variant appears to have a relatively higher transmissible rate and continues to delay progress combatting the...

FDA Approves New Pfizer Pneumococcal Vaccine for Adults

FDA Approves New Pfizer Pneumococcal Vaccine for Adults

A new pneumococcal 20-valent conjugate vaccine by Pfizer, PREVNAR 20™, has been approved for adults by the FDA in efforts to strengthen the prevention of disease and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes. The authorized vaccine not...

First Alzheimer’s Treatment by Biogen Approved by FDA

First Alzheimer’s Treatment by Biogen Approved by FDA

The U.S Food and Drug Administration (FDA) has approved Biogen’s aducanumab treatment for Alzheimer's which aims to eliminate the sticky deposits of amyloid beta found in the brains of patients in the initial stages of the disease. In spite of controversy and...

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,...