Government ❯ Regulation ❯ FDA

Drug Approval

Mifepristone Compounding Pharmacies Safety Communications Biologics License Application Patient Safety Clinical Trials Public Health Safety Labeling Changes NDA New Drug Application

3 ARTICLES

2w ago

FDA Advisory Panel Recommends Allowing Two Unproven Peptides in Pharmacies

If the FDA adopts the panel's advice, pharmacies would be able to legally prepare BPC-157 and KPV even though agency scientists say human safety and efficacy data remain inadequate.

29 ARTICLES

2w ago

FDA Advisers Recommend BPC-157 for Pharmacy Compounding

6 ARTICLES

2mo ago

Atara Faces Investor Class Action Over FDA Rejections of EBVALLO

5 ARTICLES

3mo ago

Class Action Filed Against Atara Biotherapeutics Over Alleged Misstatements on FDA Setbacks

12 ARTICLES

4mo ago

FDA Warns ImmunityBio Over Anktiva Ads, Citing Misleading Cancer Claims

5 ARTICLES

5mo ago

Compass Pathways’ Psilocybin Therapy Hits Phase 3 Goal in Treatment-Resistant Depression

4 ARTICLES

7mo ago

FDA Clears GSK’s Exdensur as First Twice-Yearly Add-On for Severe Eosinophilic Asthma

20 ARTICLES

8mo ago

FDA Proposes Adding Bemotrizinol to U.S. Sunscreens, Invites Public Comment

3 ARTICLES

8mo ago

FDA Grants Conditional Approval to Exzolt Cattle-CA1 for Screwworm and Cattle Fever Tick

5 ARTICLES

last yr.

Drug Approval

FDA Advisory Panel Recommends Allowing Two Unproven Peptides in Pharmacies

FDA Advisers Recommend BPC-157 for Pharmacy Compounding

Atara Faces Investor Class Action Over FDA Rejections of EBVALLO

Class Action Filed Against Atara Biotherapeutics Over Alleged Misstatements on FDA Setbacks

FDA Warns ImmunityBio Over Anktiva Ads, Citing Misleading Cancer Claims

Compass Pathways’ Psilocybin Therapy Hits Phase 3 Goal in Treatment-Resistant Depression

FDA Clears GSK’s Exdensur as First Twice-Yearly Add-On for Severe Eosinophilic Asthma

FDA Proposes Adding Bemotrizinol to U.S. Sunscreens, Invites Public Comment

FDA Grants Conditional Approval to Exzolt Cattle-CA1 for Screwworm and Cattle Fever Tick

FDA Mandates Opioid Label Overhaul to Quantify Long-Term Risks

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Drug Approval

FDA Investigates Fatal Liver Failures Linked to Sarepta’s Elevidys Therapy

Democratic-Led States Petition FDA to Remove Mifepristone Restrictions

Texas Judge Allows Republican-Led States to Challenge Abortion Pill Regulations

Illegal Online Pharmacies Selling Dangerous Weight Loss Drugs

FDA Encourages Lower Doses in Cancer Drug Testing

FDA Reviews MDMA-Assisted Therapy for PTSD as Congress Pushes Psychedelic Research

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Drug Approval