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FDA Approval

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3 ARTICLES

last wk.

Daraxonrasib Doubles Survival for Treated Metastatic Pancreatic Cancer in Phase 3 Trial

Using cyclophilin A to disable mutant KRAS, the oral pill has triggered an FDA expanded‑access pathway as the maker prepares expedited approval filings.

3 ARTICLES

last wk.

FDA Approves Xocova as First Oral Post-Exposure COVID-19 Prophylaxis

3 ARTICLES

2w ago

Lorundrostat Produces Blood-Pressure and Albuminuria Drops in Company Post Hoc Phase 3 Analysis

6 ARTICLES

3w ago

FDA Accepts ImmunityBio Filing to Expand ANKTIVA Use in Bladder Cancer

4 ARTICLES

4w ago

Milestone Posts Q1 Loss as CARDAMYST Launch Shows Early Uptake and AFib-RVR Phase 3 Begins

3 ARTICLES

last mo.

Intellia’s Gene-Editing Drug Cuts HAE Attacks 87% in Phase 3 as FDA Filing Begins

8 ARTICLES

last mo.

Novo Nordisk’s Oral Semaglutide Lowers HbA1c in Teens in Pivotal Trial

3 ARTICLES

last mo.

KRAS Pill Doubles Survival in Trial as Pancreatic Cancer Vaccine Advances

5 ARTICLES

last mo.

FDA Expands Tzield Use to Delay Type 1 Diabetes in Children Ages 1 to 7

5 ARTICLES

last mo.

EMA Validates Astellas Bid to Add Padcev–Keytruda Combo for Perioperative Muscle-Invasive Bladder Cancer

15 ARTICLES

last mo.

Lilly’s Oral Foundayo Matches Insulin on Heart Safety in Major Diabetes Trial

9 ARTICLES

2mo ago

FDA Approves Filspari to Reduce Proteinuria in FSGS Patients Without Nephrotic Syndrome

3 ARTICLES

2mo ago

IDEAYA Combo Doubles Progression-Free Survival in Uveal Melanoma Trial

6 ARTICLES

2mo ago

Multiple Indian Drugmakers Win U.S. Clearance to Sell Farxiga Generic

3 ARTICLES

2mo ago

FDA Approves Higher‑Dose Spinraza Regimen for Spinal Muscular Atrophy

4 ARTICLES

2mo ago

NEJM Publication Confirms Phase 3 Win for Brepocitinib in Dermatomyositis

FDA Approval

Daraxonrasib Doubles Survival for Treated Metastatic Pancreatic Cancer in Phase 3 Trial

FDA Approves Xocova as First Oral Post-Exposure COVID-19 Prophylaxis

Lorundrostat Produces Blood-Pressure and Albuminuria Drops in Company Post Hoc Phase 3 Analysis

FDA Accepts ImmunityBio Filing to Expand ANKTIVA Use in Bladder Cancer

Milestone Posts Q1 Loss as CARDAMYST Launch Shows Early Uptake and AFib-RVR Phase 3 Begins

Moderna’s mRNA Flu Shot Tops Standard Vaccine in Large Phase 3 Trial

FDA Authorizes Early Access to Daraxonrasib for Pancreatic Cancer Patients

FDA Approves Auvelity as First Non‑Antipsychotic for Alzheimer’s Agitation

Pfizer’s Elrexfio Posts Phase 3 PFS Win Over Standard Multiple Myeloma Regimen

Intellia’s Gene-Editing Drug Cuts HAE Attacks 87% in Phase 3 as FDA Filing Begins

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FDA Approval

Novo Nordisk’s Oral Semaglutide Lowers HbA1c in Teens in Pivotal Trial

KRAS Pill Doubles Survival in Trial as Pancreatic Cancer Vaccine Advances

FDA Expands Tzield Use to Delay Type 1 Diabetes in Children Ages 1 to 7

EMA Validates Astellas Bid to Add Padcev–Keytruda Combo for Perioperative Muscle-Invasive Bladder Cancer

Lilly’s Oral Foundayo Matches Insulin on Heart Safety in Major Diabetes Trial

FDA Approves Filspari to Reduce Proteinuria in FSGS Patients Without Nephrotic Syndrome

IDEAYA Combo Doubles Progression-Free Survival in Uveal Melanoma Trial

Multiple Indian Drugmakers Win U.S. Clearance to Sell Farxiga Generic

FDA Approves Higher‑Dose Spinraza Regimen for Spinal Muscular Atrophy

NEJM Publication Confirms Phase 3 Win for Brepocitinib in Dermatomyositis

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FDA Approval