Category: Regulations
-
FDA Okays Trial of Donated Stem Cells for Parkinson’s
An organization studying stem cell therapies says it received FDA authorization for a clinical trial to test donated stem cells to treat Parkinson’s disease.
-
FDA Okays Lower Dose, Injected Covid-19 Antibodies
The Food and Drug Administration updated its emergency authorization for a dual-antibody Covid-19 therapy to allow for a lower and injectable dose.
-
Trial Shows Same High/Low Dose Aspirin Outcomes
Results from a large-scale clinical trial show almost the same health outcomes for patients prescribed high or low doses of aspirin to prevent heart disease.
-
Lilly Asks FDA to Revoke Covid-19 Therapy Clearance
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.
-
NIH Trial Testing mRNA Vaccine Allergic Effects
A clinical trial is underway testing for allergic reactions to Covid-19 vaccines using messenger RNA for invoking an immune response.
-
Coupons, Vouchers Used for Few Prescription Drugs
An analysis of customer transactions shows discounts from suppliers are used for only a small fraction of prescription drugs on the market.
-
FDA Authorizes Non-Prescription 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.
-
NIH Assessing Home Covid-19 Diagnostic with App
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.
-
Diagnostic Cleared for Covid-19, Other Diseases
A single diagnostic test for the virus causing Covid-19 infections and three other respiratory diseases received clearance for marketing in Europe.
-
ALS Trial Results Deemed Insufficient for FDA Approval
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.