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WuXi STA Passes the First U.S. FDA Drug Product Pre-Approval Inspection at its Shanghai Waigaoqiao Site

WuXi STA – a subsidiary of WuXi AppTec, announced that its Waigaoqiao site in Shanghai, China, successfully passed the first drug product pre-approval inspection...

FDA Authorizes Use of Oral Antiviral Molnupiravir for Mild to Moderate COVID-19

Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the U.S. Food and Drug Administration (FDA) has...

Pfizer Receives U.S. FDA Emergency Use Authorization for Novel COVID-19 Oral Antiviral Treatment

Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has authorized the emergency use of PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets)...

COVID-19 convalescent plasma did not prevent the progression of the disease

The trial was conducted by the SIREN clinical trials network and enrolled more than 500 participants.

FDA Authorizes Additional COVID-19 Vaccine Dose for Certain Immunocompromised Individuals

The FDA evaluated information on the use of a third dose of the Pfizer-BioNTech or Moderna Vaccines and determined that the administration of third vaccine doses may increase protection in this population.

FDA warns of clinical trial results showing increased risk of death associated with Pepaxto

Due to the detrimental effect on overall survival in the OCEAN trial, FDA is requiring the manufacturer suspend enrollment in the trial.
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