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Drug Approval

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5 ARTICLES

2w ago

FDA Approves Brinsupri as First Therapy for Non-Cystic Fibrosis Bronchiectasis

About 500,000 Americans living with chronic bronchiectasis now have an FDA-approved option following trial data showing significant cuts in flare-ups.

11 ARTICLES

2w ago

FDA Reinstates Biologics Director Vinay Prasad Less Than Two Weeks After Resignation

6 ARTICLES

2w ago

Mounjaro Rivals Trulicity in Cardiovascular Safety and Lowers All-Cause Mortality

27 ARTICLES

4w ago

Vinay Prasad Resigns as FDA Biologics Director After Politicized Tenure

5 ARTICLES

last mo.

EMA Recommends Restricted Approval for Eli Lilly’s Alzheimer’s Drug Kisunla

7 ARTICLES

last mo.

Sarepta Defies FDA, Keeps Duchenne Gene Therapy on the Market

8 ARTICLES

last mo.

FDA Advisers Recommend Against Approval of GSK’s Myeloma Drug Blenrep

3 ARTICLES

last mo.

FDA Publishes Over 200 Complete Response Letters for 2020–24 Drug Applications

6 ARTICLES

last mo.

UK Administers First Teplizumab Immunotherapy to Adult Type 1 Diabetes Patient

5 ARTICLES

2mo ago

Campaigners Demand NHS Reform After Enhertu Price Talks Collapse

4 ARTICLES

2mo ago

Italy Reimburses Iptacopan, First Oral Monotherapy for PNH

4 ARTICLES

2mo ago

Eli Lilly’s Oral GLP-1 Pill Matches Injectables in Weight and Blood Sugar Control

3 ARTICLES

2mo ago

FDA Approves Regeneron and Sanofi’s Dupixent for Bullous Pemphigoid

3 ARTICLES

2mo ago

BMJ Reveals Data Flaws in Pivotal Ticagrelor FDA Approval Studies

8 ARTICLES

2mo ago

NICE Bars New Alzheimer’s Antibodies from NHS Over Cost and Capacity

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Drug Approval

FDA Approves Brinsupri as First Therapy for Non-Cystic Fibrosis Bronchiectasis

FDA Reinstates Biologics Director Vinay Prasad Less Than Two Weeks After Resignation

FDA Approves Vizz Eye Drops for Presbyopia

FDA Grants Accelerated Approval to Zongertinib for HER2-Mutant Lung Cancer

FDA Approves VIZZ, First Aceclidine Eye Drop for Age-Related Presbyopia

FDA Approves First Systemic Therapy for H3 K27M-Mutant Diffuse Midline Glioma

NICE Approves Keytruda Combo for Advanced Endometrial Cancer on NHS

Mounjaro Rivals Trulicity in Cardiovascular Safety and Lowers All-Cause Mortality

Vinay Prasad Resigns as FDA Biologics Director After Politicized Tenure

EMA Recommends Restricted Approval for Eli Lilly’s Alzheimer’s Drug Kisunla

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Drug Approval

Sarepta Defies FDA, Keeps Duchenne Gene Therapy on the Market

FDA Advisers Recommend Against Approval of GSK’s Myeloma Drug Blenrep

FDA Publishes Over 200 Complete Response Letters for 2020–24 Drug Applications

UK Administers First Teplizumab Immunotherapy to Adult Type 1 Diabetes Patient

Campaigners Demand NHS Reform After Enhertu Price Talks Collapse

Italy Reimburses Iptacopan, First Oral Monotherapy for PNH

Eli Lilly’s Oral GLP-1 Pill Matches Injectables in Weight and Blood Sugar Control

FDA Approves Regeneron and Sanofi’s Dupixent for Bullous Pemphigoid

BMJ Reveals Data Flaws in Pivotal Ticagrelor FDA Approval Studies

NICE Bars New Alzheimer’s Antibodies from NHS Over Cost and Capacity

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Drug Approval