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FDA Regulations

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

Mouse tests show higher tumor drug buildup with restored activity, prompting preclinical optimization of safety and dosing for possible clinical testing.

19 ARTICLES

4w ago

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

74 ARTICLES

4mo ago

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

13 ARTICLES

4mo ago

India Tightens Oversight of GLP-1 Diabetes and Weight-Loss Drugs

7 ARTICLES

4mo ago

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

12 ARTICLES

4mo ago

FDA Warns ImmunityBio Over Anktiva Ads, Citing Misleading Cancer Claims

55 ARTICLES

4mo ago

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

6 ARTICLES

4mo ago

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

3 ARTICLES

5mo ago

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

3 ARTICLES

5mo ago

FDA Sets Single-Study Default for New Drug Approvals

4 ARTICLES

6mo ago

FDA Rejects Regenxbio’s Hunter Syndrome Gene Therapy Application

9 ARTICLES

7mo ago

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

45 ARTICLES

7mo ago

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

6 ARTICLES

9mo ago

Roche’s Oral BTK Drug Succeeds in Phase 3 MS Trials, Matching Ocrevus in Progressive Disease

30 ARTICLES

9mo ago

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

5 ARTICLES

10mo ago

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

4 ARTICLES

10mo ago

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

FDA Regulations

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

FDA Approves Lipfendra, First Oral PCSK9 Pill to Cut LDL

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

India Tightens Oversight of GLP-1 Diabetes and Weight-Loss Drugs

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

FDA Warns ImmunityBio Over Anktiva Ads, Citing Misleading Cancer Claims

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

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FDA Regulations

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

Roche’s Oral BTK Drug Succeeds in Phase 3 MS Trials, Matching Ocrevus in Progressive Disease

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