FDA Approves First Oral Treatment for Anemia for Adults on Dialysis
U.S. Food and Drug Administration
With its safety unclear, Jesduvroq is approved only for those with anemia and on dialysis
Articles by U.S. Food and Drug Administration
FDA Proposes to Revise Blood Donor Eligibility Assessment
U.S. Food and Drug Administration
Measures would abate the risk of transmittable diseases and safeguard blood supply in the US
FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment
U.S. Food and Drug Administration
Leqembi has been approved via the accelerated approval pathway for the treatment of Alzheimer's
FDA Approves New HIV Drug for Adults with Limited Treatment Options
U.S. Food and Drug Administration
The new medication is for those whose HIV infections cannot be successfully treated with other treatments
FDA Approves First Gene Therapy to Treat Adults with Hemophilia B
U.S. Food and Drug Administration
The one-time gene therapy, Hemgenix, was evaluated in two studies and was found to decrease annualized bleeding rate
FDA Authorizes COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups
U.S. Food and Drug Administration
The EUAs for Moderna and Pfizer-BioNTech COVID-19 Vaccine, Bivalent has been amended
New Guidance Aims to Protect Children Who Participate in Clinical Trials
U.S. Food and Drug Administration
The draft guidance is intended to assist industry, sponsors, and institutional review boards
Public-Private Partnership for Rare Neurodegenerative Diseases
U.S. Food and Drug Administration
The FDA and NIH launch a partnership aimed at understanding and combating rare neurodegenerative diseases
FDA Removes N95 Respirators from Medical Device Shortage List
U.S. Food and Drug Administration
Agency continues to monitor supply chain to help ensure continued access
FDA Releases Action Plan for Rare Neurodegenerative Diseases
U.S. Food and Drug Administration
Five-year plan fulfills a requirement of the Accelerating Access to Critical Therapies for ALS Act