Regulations « Science and Enterprise

Lilly Asks FDA to Revoke Covid-19 Therapy Clearance

By Alan, on April 16th, 2021%

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

By Alan, on April 8th, 2021%

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

By Alan, on March 30th, 2021%

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

By Alan, on March 6th, 2021%

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

By Alan, on March 1st, 2021%

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

By Alan, on March 1st, 2021%

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

By Alan, on February 23rd, 2021%

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

By Alan, on February 22nd, 2021%

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

By Alan, on February 12th, 2021%

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

By Alan, on February 10th, 2021%

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

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