FDA

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3 ARTICLES

3d ago

FDA Authorizes Zyn to Market Reduced‑Risk Claims for 20 Nicotine Pouch Products

The orders let 20 Zyn products carry a claim under five‑year limits, mandatory postmarket surveillance, FDA power to withdraw claims for rising population harms, and conditions that apply only to the listed items.

15 ARTICLES

5d ago

FDA Allows Zyn to Be Marketed as Lower Risk Than Cigarettes

3 ARTICLES

last wk.

Youth Tobacco Use Falls to Multi-Year Low, But Vaping and Pouches Keep Risks High

7 ARTICLES

2w ago

FDA Agrees Three‑Year Phase I/II Data Can Support uniQure’s AMT‑130 Accelerated BLA

10 ARTICLES

3w ago

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

46 ARTICLES

3w ago

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

13 ARTICLES

2mo ago

FDA Panel Rejects AstraZeneca Breast Cancer Drug, Backs Prostate Therapy

5 ARTICLES

2mo ago

Psychedelic Therapies Gain Momentum After Trump Order

7 ARTICLES

2mo ago

FDA Elevates Ayco Farms Cantaloupe Recall to Class I Over Salmonella Risk

5 ARTICLES

3mo ago

FDA Flags Recall of 3.1 Million Store-Brand Eye Drops Over Sterility Concerns

3 ARTICLES

3mo ago

FDA Warns ImmunityBio Over Anktiva Ads as Company Adds $100 Million for Expansion

7 ARTICLES

3mo ago

E. Coli Outbreak Tied to Raw Farm Raw Cheddar Rises to Nine as FDA Probes

12 ARTICLES

3mo ago

FDA Warns ImmunityBio Over Anktiva Ads, Citing Misleading Cancer Claims

3 ARTICLES

3mo ago

uniQure Soars 36% After FDA Biologics Chief Vinay Prasad Announces April Exit

6 ARTICLES

4mo ago

FDA Demands Placebo-Controlled Trial for UniQure’s Huntington’s Gene Therapy

FDA

FDA Authorizes Zyn to Market Reduced‑Risk Claims for 20 Nicotine Pouch Products

FDA Allows Zyn to Be Marketed as Lower Risk Than Cigarettes

Youth Tobacco Use Falls to Multi-Year Low, But Vaping and Pouches Keep Risks High

FDA Agrees Three‑Year Phase I/II Data Can Support uniQure’s AMT‑130 Accelerated BLA

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

FDA Adds Bemotrizinol to U.S. Sunscreen Ingredients

Study Finds Vaping Alters 3,124 Genes and Flavors Drive Most Changes

FDA Clears Tempus xT CDx to Run as Tumor‑Only Diagnostic

Atara Faces Investor Class Action Over FDA Rejections of EBVALLO

Compass Pathways Rises on Q1 Beat as FDA Accepts Rolling Review for COMP360

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FDA

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

FDA Panel Rejects AstraZeneca Breast Cancer Drug, Backs Prostate Therapy

Psychedelic Therapies Gain Momentum After Trump Order

FDA Elevates Ayco Farms Cantaloupe Recall to Class I Over Salmonella Risk

FDA Flags Recall of 3.1 Million Store-Brand Eye Drops Over Sterility Concerns

FDA Warns ImmunityBio Over Anktiva Ads as Company Adds $100 Million for Expansion

E. Coli Outbreak Tied to Raw Farm Raw Cheddar Rises to Nine as FDA Probes

FDA Warns ImmunityBio Over Anktiva Ads, Citing Misleading Cancer Claims

uniQure Soars 36% After FDA Biologics Chief Vinay Prasad Announces April Exit

FDA Demands Placebo-Controlled Trial for UniQure’s Huntington’s Gene Therapy

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FDA