Biotechnology

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3 ARTICLES

2w ago

Amgen’s Dazodalibep Meets Primary Goal in Phase 3 Sjögren’s Trial

The topline result raises the prospect of the first FDA‑approved therapy for Sjögren’s disease, with full data and a second Phase 3 readout determining approval chances.

6 ARTICLES

2w ago

FDA Approves Fayuvi, Ultragenyx’s $3.95 Million One‑Time Gene Therapy for Sanfilippo A

5 ARTICLES

last mo.

FDA Grants Accelerated Approval to Kresladi, First Gene Therapy for Severe Pediatric LAD-1

6 ARTICLES

6mo ago

Kodiak’s Zenkuda Hits Phase 3 Goal in Diabetic Retinopathy Prompting Faster FDA Filing

5 ARTICLES

6mo ago

FDA Grants Accelerated Approval to Avlayah for Neurologic Manifestations of Hunter Syndrome

6 ARTICLES

7mo ago

Vertex’s IgA Nephropathy Drug Hits Phase 3 Goals, FDA Filing Slated for March

8 ARTICLES

7mo ago

Zealand Plunges as Roche Obesity Drug Posts 10.7% Weight Loss With Placebo‑Like Tolerability

15 ARTICLES

7mo ago

Moderna Reaches Up to $2.25 Billion LNP Patent Settlement, Pays $950 Million Upfront

7 ARTICLES

7mo ago

FDA Rejects Filing of Moderna’s mRNA Flu Vaccine Over Comparator Dispute

6 ARTICLES

8mo ago

FDA Issues Second Rejection of Atara’s EBV+ PTLD Therapy Tabelecleucel

5 ARTICLES

9mo ago

Lilly and Nimbus Strike Multi-Year AI Deal for Oral Obesity Drugs

5 ARTICLES

9mo ago

FDA Issues Complete Response Letter for Corcept’s Relacorilant in Cushing’s-Related Hypertension

Biotechnology

Amgen’s Dazodalibep Meets Primary Goal in Phase 3 Sjögren’s Trial

FDA Approves Fayuvi, Ultragenyx’s $3.95 Million One‑Time Gene Therapy for Sanfilippo A

FDA Approves Rusfertide (Mimrylo) for Polycythemia Vera

FDA Approves Regeneron’s Pasatru for Adults With FOP

FDA Advisers Find Replimune’s RP1 Trial Results Clinically Meaningful

Biogen to Buy RayThera for Up to $1 Billion

Ivonescimab Extends Survival in China Phase 3 Trial for Squamous Lung Cancer

FDA Authorizes Early Access to Daraxonrasib for Pancreatic Cancer Patients

FDA Issues Second Rejection of Replimune’s RP1 Melanoma Therapy

Spyre Drug Meets Midstage Target in Ulcerative Colitis, Stock Rallies

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Biotechnology

FDA Grants Accelerated Approval to Kresladi, First Gene Therapy for Severe Pediatric LAD-1

Kodiak’s Zenkuda Hits Phase 3 Goal in Diabetic Retinopathy Prompting Faster FDA Filing

FDA Grants Accelerated Approval to Avlayah for Neurologic Manifestations of Hunter Syndrome

Vertex’s IgA Nephropathy Drug Hits Phase 3 Goals, FDA Filing Slated for March

Zealand Plunges as Roche Obesity Drug Posts 10.7% Weight Loss With Placebo‑Like Tolerability

Moderna Reaches Up to $2.25 Billion LNP Patent Settlement, Pays $950 Million Upfront

FDA Rejects Filing of Moderna’s mRNA Flu Vaccine Over Comparator Dispute

FDA Issues Second Rejection of Atara’s EBV+ PTLD Therapy Tabelecleucel

Lilly and Nimbus Strike Multi-Year AI Deal for Oral Obesity Drugs

FDA Issues Complete Response Letter for Corcept’s Relacorilant in Cushing’s-Related Hypertension

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Biotechnology