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FDA Regulations

Moderna and Merck Report Positive Phase 3 Results for Personalized Melanoma Vaccine

The interim finding shows the vaccine plus Keytruda reduced recurrence and distant spread in high‑risk, resected melanoma and could prompt regulator talks once full data are released.

5 ARTICLES

2mo ago

FDA Clears Eli Lilly’s Foundayo Oral GLP-1 for Weight Loss, With U.S. Launch Set for April 6

74 ARTICLES

6mo ago

FDA Clears Lilly’s Foundayo Pill, Escalating GLP-1 Weight-Loss Rivalry

7 ARTICLES

6mo ago

FDA Approves Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes

12 ARTICLES

6mo ago

FDA Warns ImmunityBio Over Anktiva Ads, Citing Misleading Cancer Claims

55 ARTICLES

6mo ago

FDA Clears 7.2‑mg Wegovy as India Enters Generic Semaglutide Era

6 ARTICLES

6mo ago

For Third Time, FDA Rejects Aldeyra’s Dry-Eye Drug Reproxalap Over Efficacy

3 ARTICLES

7mo ago

FDA Approves First All-Oral, Fixed-Duration First-Line CLL/SLL Regimen: Calquence Plus Venetoclax

3 ARTICLES

7mo ago

FDA Sets Single-Study Default for New Drug Approvals

4 ARTICLES

7mo ago

FDA Rejects Regenxbio’s Hunter Syndrome Gene Therapy Application

9 ARTICLES

9mo ago

FDA Approves Vanda’s Nereus, First New Motion Sickness Treatment in Over 40 Years

45 ARTICLES

9mo ago

FDA Approves Wegovy Weight-Loss Pill as First Oral GLP-1 for Obesity

30 ARTICLES

11mo ago

U.S. Strikes Price-Cut Deals With Novo Nordisk and Eli Lilly for GLP‑1s, With Medicare Pilot in 2026

5 ARTICLES

11mo ago

Cytokinetics Investors Urged to Act as Lead‑Plaintiff Deadline Nears in REMS‑Related Securities Suit

4 ARTICLES

last yr.

Cytokinetics Faces Investor Class Action Over Aficamten REMS Disclosures as Lead-Plaintiff Deadline Nears

FDA Regulations

Moderna and Merck Report Positive Phase 3 Results for Personalized Melanoma Vaccine

Eli Lilly Opens Limited Early Access to Experimental Obesity Drug Retatrutide

FDA Approves First Oral PCSK9 Pill, Merck’s Lipfendra

WashU Team Uses In‑Body Click Chemistry to Assemble Dual‑Target Cancer Drugs

FDA Orders New Kidney Warning for Orlistat Weight‑Loss Pills

FDA Approves First Gene Therapy for Inherited Hearing Loss

FDA Clears Eli Lilly’s Foundayo Oral GLP-1 for Weight Loss, With U.S. Launch Set for April 6

FDA Clears Lilly’s Foundayo Pill, Escalating GLP-1 Weight-Loss Rivalry

FDA Approves Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes

FDA Warns ImmunityBio Over Anktiva Ads, Citing Misleading Cancer Claims

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FDA Regulations

FDA Clears 7.2‑mg Wegovy as India Enters Generic Semaglutide Era

For Third Time, FDA Rejects Aldeyra’s Dry-Eye Drug Reproxalap Over Efficacy

FDA Approves First All-Oral, Fixed-Duration First-Line CLL/SLL Regimen: Calquence Plus Venetoclax

FDA Sets Single-Study Default for New Drug Approvals

FDA Rejects Regenxbio’s Hunter Syndrome Gene Therapy Application

FDA Approves Vanda’s Nereus, First New Motion Sickness Treatment in Over 40 Years

FDA Approves Wegovy Weight-Loss Pill as First Oral GLP-1 for Obesity

U.S. Strikes Price-Cut Deals With Novo Nordisk and Eli Lilly for GLP‑1s, With Medicare Pilot in 2026

Cytokinetics Investors Urged to Act as Lead‑Plaintiff Deadline Nears in REMS‑Related Securities Suit

Cytokinetics Faces Investor Class Action Over Aficamten REMS Disclosures as Lead-Plaintiff Deadline Nears

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FDA Regulations