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Lilly Asks FDA to Revoke Covid-19 Therapy Clearance

SARS-CoV-2 and cell

Drug maker Eli Lilly and Co. asked the Food and Drug Administration to revoke its authorization for bamlanivimab alone to treat for Covid-19 infections. . . . → Read More: Lilly Asks FDA to Revoke Covid-19 Therapy Clearance

NIH Trial Testing mRNA Vaccine Allergic Effects

Syringe

A clinical trial is underway testing for allergic reactions to Covid-19 vaccines using messenger RNA for invoking an immune response. . . . → Read More: NIH Trial Testing mRNA Vaccine Allergic Effects

Coupons, Vouchers Used for Few Prescription Drugs

Pills and dollar bill

An analysis of customer transactions shows discounts from suppliers are used for only a small fraction of prescription drugs on the market. . . . → Read More: Coupons, Vouchers Used for Few Prescription Drugs

FDA Authorizes Non-Prescription Covid-19 Test

Cue Covid-19 test

Food and Drug Administration granted an emergency authorization for a molecular test for SARS-CoV-2 viruses done at home without a prescription. . . . → Read More: FDA Authorizes Non-Prescription Covid-19 Test

NIH Assessing Home Covid-19 Diagnostic with App

QuickVue test package

A home Covid-19 test is being evaluated with a smartphone app, as part of an NIH program to quickly develop Covid-19 diagnostics for widespread use. . . . → Read More: NIH Assessing Home Covid-19 Diagnostic with App

Diagnostic Cleared for Covid-19, Other Diseases

Amplidiag Easy system

A single diagnostic test for the virus causing Covid-19 infections and three other respiratory diseases received clearance for marketing in Europe. . . . → Read More: Diagnostic Cleared for Covid-19, Other Diseases

ALS Trial Results Deemed Insufficient for FDA Approval

Neurons illustration

An ALS treatment developer says the Food and Drug Administration advised the company’s clinical trial data would likely not support approval for patient use. . . . → Read More: ALS Trial Results Deemed Insufficient for FDA Approval

FDA Issues Covid-19 Variant Regulatory Guidance

Covid-19 testing

Food and Drug Administration is updating its regulatory guidance for Covid-19 drugs and diagnostics to cover emerging mutations in the SARS-CoV-2 virus. . . . → Read More: FDA Issues Covid-19 Variant Regulatory Guidance

20 Precision Meds Approved by FDA in 2020

Syringe, pills, capsules

A report by a group advocating for precision medicine notes that the Food and Drug Administration approved 20 new personalized drugs and biologics in 2020. . . . → Read More: 20 Precision Meds Approved by FDA in 2020

FDA Clears Covid-19 Dual-Antibody Therapy

SARS-Cov-2 viruses

The Food and Drug Administration granted an emergency authorization for a combination of two synthetic antibodies to treat non-hospitalized Covid-19 infections. . . . → Read More: FDA Clears Covid-19 Dual-Antibody Therapy