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FDA

Clinical Trials Accelerated Approval ARS Pharmaceuticals Lenacapavir Approval GLP-1 Medications Novo Nordisk Eli Lilly Injectable Medications Medical Devices Kisqali AstraZeneca Regulatory Decisions Cobenfy Efficacy and Safety Suzetrigine Public Health GSK New Drug Class Vanda Pharmaceuticals Novavax Clinical Investigations New Drug Application Yeztugo Brinsupri Orforglipron Approval Wegovy Pill NaV1.8 Inhibitors Aceclidine Approval Precigen Blenrep Combination Therapy Generic Drugs Eydenzelt Breakthrough Therapy Designation DARZALEX FASPRO Blujepa First-in-Class Therapies Ziftomenib Biosimilar Approval Mosunetuzumab Cancer Therapies Weight Loss Treatments Medication Efficacy Drug Evaluation Weight Loss Medications Foundayo Sunscreen Ingredients Ultragenyx Pharmaceutical Zanidatamab-hrii Tirzepatide Approval Oncology Daraxonrasib

6 ARTICLES

3w ago

FDA Approves Camizestrant for ESR1‑Mutated Advanced Breast Cancer

The decision lets doctors switch an aromatase inhibitor to the oral SERD camizestrant after a blood test finds an ESR1 resistance mutation, with confirmatory trials required.

5 ARTICLES

4w ago

FDA Approves Rusfertide (Mimrylo) for Polycythemia Vera

10 ARTICLES

last mo.

FDA Approves Mounjaro to Lower Heart‑Attack and Stroke Risk in High‑Risk Type 2 Diabetes

8 ARTICLES

last mo.

FDA Approves Zanidatamab Regimens for First‑Line HER2‑Positive Gastroesophageal Cancer

6 ARTICLES

last mo.

FDA Grants Accelerated Approval to Genglycos for Glycogen Storage Disease Type Ia

10 ARTICLES

3mo ago

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

4 ARTICLES

4mo ago

FDA Grants Accelerated Approval to First BCL2 Drug for Relapsed Mantle Cell Lymphoma

3 ARTICLES

5mo ago

Single CAR T Infusion Clears Residual Disease in High-Risk Smoldering Myeloma Trial

9 ARTICLES

6mo ago

GSK Gains After Cramer Endorsement as Company Pushes Into Weight-Loss Drugs

9 ARTICLES

9mo ago

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

4 ARTICLES

9mo ago

FDA Grants Accelerated Approval to Subcutaneous Lunsumio for Relapsed Follicular Lymphoma

3 ARTICLES

10mo ago

FDA Approves Poherdy as First Interchangeable Biosimilar to Perjeta for HER2-Positive Breast Cancer

6 ARTICLES

11mo ago

FDA Approves Darzalex Faspro as First Therapy for High-Risk Smoldering Multiple Myeloma

9 ARTICLES

11mo ago

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

7 ARTICLES

last yr.

FDA Approves Lurbinectedin Plus Atezolizumab for First-Line Maintenance in Extensive-Stage SCLC

4 ARTICLES

last yr.

FDA Approves Keytruda QLEX, a Rapid Subcutaneous Option for Most Adult Solid Tumor Uses

5 ARTICLES

last yr.

FDA Approves Papzimeos as First Therapy for Adult Recurrent Respiratory Papillomatosis

9 ARTICLES

last yr.

FDA Approves Brensocatib as First Treatment for Non-Cystic Fibrosis Bronchiectasis

3 ARTICLES

last yr.

Vertex Halts VX-993 Acute Pain Program After Phase 2 Trial Failure

FDA

FDA Approves Camizestrant for ESR1‑Mutated Advanced Breast Cancer

FDA Approves Rusfertide (Mimrylo) for Polycythemia Vera

FDA Approves Mounjaro to Lower Heart‑Attack and Stroke Risk in High‑Risk Type 2 Diabetes

FDA Approves Zanidatamab Regimens for First‑Line HER2‑Positive Gastroesophageal Cancer

FDA Grants Accelerated Approval to Genglycos for Glycogen Storage Disease Type Ia

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

FDA Grants Accelerated Approval to First BCL2 Drug for Relapsed Mantle Cell Lymphoma

Single CAR T Infusion Clears Residual Disease in High-Risk Smoldering Myeloma Trial

GSK Gains After Cramer Endorsement as Company Pushes Into Weight-Loss Drugs

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

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FDA

FDA Grants Accelerated Approval to Subcutaneous Lunsumio for Relapsed Follicular Lymphoma

FDA Approves Poherdy as First Interchangeable Biosimilar to Perjeta for HER2-Positive Breast Cancer

FDA Approves Darzalex Faspro as First Therapy for High-Risk Smoldering Multiple Myeloma

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

FDA Approves Lurbinectedin Plus Atezolizumab for First-Line Maintenance in Extensive-Stage SCLC

FDA Approves Keytruda QLEX, a Rapid Subcutaneous Option for Most Adult Solid Tumor Uses

FDA Approves Papzimeos as First Therapy for Adult Recurrent Respiratory Papillomatosis

FDA Approves Brensocatib as First Treatment for Non-Cystic Fibrosis Bronchiectasis

Vertex Halts VX-993 Acute Pain Program After Phase 2 Trial Failure

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FDA