FDA Regulations

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3 ARTICLES

2w ago

FDA and HHS Update Testosterone Labels to Ease Age-Related Warnings

HHS says the change follows a large 2023 trial and expert review to widen appropriate access while keeping contraindications for advanced prostate cancer.

10 ARTICLES

3w ago

FDA Adds Bemotrizinol to U.S. Sunscreen Ingredients, First New Filter in Over 20 Years

3 ARTICLES

2mo ago

FDA Clears Motif Neurotech Trial of At-Home Brain Implant for Treatment-Resistant Depression

7 ARTICLES

3mo ago

Pfizer and BioNTech Halt U.S. COVID Vaccine Trial for 50–64-Year-Olds Over Slow Enrollment

10 ARTICLES

4mo ago

FDA Proposes ‘Plausible Mechanism’ Pathway for Individualized Rare-Disease Therapies

10 ARTICLES

6mo ago

OTC Birth Control Tied to Major Uptake Gains in First Year, National Study Finds

4 ARTICLES

11mo ago

FDA Hears Final Testimony on Removing Prescription Fluoride Supplements

7 ARTICLES

last yr.

More Than 10 Major Food Companies Pledge to Phase Out Synthetic Dyes

3 ARTICLES

last yr.

FDA Expands Myocarditis and Pericarditis Warnings on mRNA COVID-19 Vaccines

8 ARTICLES

last yr.

FDA launches AI assistant Elsa early as staff flag readiness issues

10 ARTICLES

last yr.

FDA Approves Moderna’s mNEXSPIKE for Seniors and High-Risk Adults as CDC Drops Recommendations for Healthy Children and Pregnant Women

FDA Regulations

FDA and HHS Update Testosterone Labels to Ease Age-Related Warnings

FDA Adds Bemotrizinol to U.S. Sunscreen Ingredients, First New Filter in Over 20 Years

FDA Clears Motif Neurotech Trial of At-Home Brain Implant for Treatment-Resistant Depression

Pfizer and BioNTech Halt U.S. COVID Vaccine Trial for 50–64-Year-Olds Over Slow Enrollment

FDA Proposes ‘Plausible Mechanism’ Pathway for Individualized Rare-Disease Therapies

FDA Opens Safety Review of Infant RSV Antibody Drugs Beyfortus and Enflonsia

FDA Clears Second Generic Mifepristone as White House Cites Legal Duty

FDA Clears Signos’ AI CGM for Weight Management as OTC Service Launches

OTC Birth Control Tied to Major Uptake Gains in First Year, National Study Finds

FDA Hears Final Testimony on Removing Prescription Fluoride Supplements

More Than 10 Major Food Companies Pledge to Phase Out Synthetic Dyes

FDA Expands Myocarditis and Pericarditis Warnings on mRNA COVID-19 Vaccines

FDA launches AI assistant Elsa early as staff flag readiness issues

FDA Approves Moderna’s mNEXSPIKE for Seniors and High-Risk Adults as CDC Drops Recommendations for Healthy Children and Pregnant Women