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Regulatory Approval

FDA FDA Approval NHS Drug Approval Process European Commission European Medicines Agency Health Authorities Wegovy Approval Process Medical Devices Drug Development

3 ARTICLES

12h ago

Mezigdomide Triplet Cuts Risk of Myeloma Progression by 52% in Phase 3 Trial

The SUCCESSOR-2 results offer a potent oral treatment option that markedly lengthened progression-free survival while raising safety and approval questions.

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8 ARTICLES

3mo ago

Lilly Launches FDA-Cleared Monthly Zepbound KwikPen on LillyDirect at $299 Starter Price

7 ARTICLES

3mo ago

EU Grants Conditional Approval for ImmunityBio’s Anktiva in BCG‑Unresponsive Bladder Cancer

4 ARTICLES

4mo ago

ImmunityBio Extends Rally to 52-Week High on Anktiva Sales, Saudi Approval and Trial Progress

4 ARTICLES

5mo ago

Cosmo’s Clascoterone Meets Phase III Goals in Male-Pattern Baldness Trials

4 ARTICLES

5mo ago

Zydus to Commercialize FDA-Approved Interchangeable Lucentis Biosimilar NUFYMCO in U.S. Under Bioeq Deal

11 ARTICLES

5mo ago

FDA Approves First Wegovy Pill for Chronic Weight Management

4 ARTICLES

5mo ago

Lilly Files Orforglipron Obesity Pill With FDA After Trial Shows Weight-Loss Maintenance

4 ARTICLES

5mo ago

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

8 ARTICLES

5mo ago

Epcoritamab Added to R2 Yields Large Efficacy Gains in Relapsed Follicular Lymphoma

6 ARTICLES

5mo ago

European Commission Approves Gilead’s Twice-Yearly HIV PrEP Yeytuo for EU Market

3 ARTICLES

9mo ago

Health Canada Clears LP.8.1‑Targeted Pfizer and Moderna COVID‑19 Vaccines for Fall Use

3 ARTICLES

9mo ago

Cofepris Authorizes Bi-Monthly Injectable PrEP in Mexico

5 ARTICLES

9mo ago

FTC Files to Block Edwards Lifesciences’ $945 Million JenaValve Acquisition

6 ARTICLES

10mo ago

FDA Approves First Implanted Vagus Nerve Stimulator for Rheumatoid Arthritis

3 ARTICLES

10mo ago

Regulatory Approval

Mezigdomide Triplet Cuts Risk of Myeloma Progression by 52% in Phase 3 Trial

Lilly Launches FDA-Cleared Monthly Zepbound KwikPen on LillyDirect at $299 Starter Price

EU Grants Conditional Approval for ImmunityBio’s Anktiva in BCG‑Unresponsive Bladder Cancer

ImmunityBio Extends Rally to 52-Week High on Anktiva Sales, Saudi Approval and Trial Progress

Cosmo’s Clascoterone Meets Phase III Goals in Male-Pattern Baldness Trials

Zydus to Commercialize FDA-Approved Interchangeable Lucentis Biosimilar NUFYMCO in U.S. Under Bioeq Deal

FDA Approves First Wegovy Pill for Chronic Weight Management

Lilly Files Orforglipron Obesity Pill With FDA After Trial Shows Weight-Loss Maintenance

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

Epcoritamab Added to R2 Yields Large Efficacy Gains in Relapsed Follicular Lymphoma

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Regulatory Approval

IQWiG Says Leqembi Shows No Added Benefit for Early Alzheimer’s Patients

Fuji Rebio Seeks Japan Approval for Blood Test to Aid Alzheimer’s Diagnosis

FDA Reapproves GSK’s Blenrep for Multiple Myeloma in Narrow Combination Use

Cannabis-Inspired Drug Shows Weight Gain in Small Cancer Cachexia Trial

European Commission Approves Gilead’s Twice-Yearly HIV PrEP Yeytuo for EU Market

Health Canada Clears LP.8.1‑Targeted Pfizer and Moderna COVID‑19 Vaccines for Fall Use

Cofepris Authorizes Bi-Monthly Injectable PrEP in Mexico

FTC Files to Block Edwards Lifesciences’ $945 Million JenaValve Acquisition

FDA Approves First Implanted Vagus Nerve Stimulator for Rheumatoid Arthritis

FDA Approves IL-23 Inhibitor Tremfya for Moderate-to-Severe Crohn’s Disease

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Regulatory Approval