Biotechnology

Clinical Trials Drug Development Clinical Research Sanofi Roche Moderna Company Operations Research and Development Regeneron Pharmaceuticals Clinical Research Organizations

4 ARTICLES

3w ago

China Phase 3 Shows 34% Drop in Death Risk for Experimental Lung Cancer Drug

Regulators and investors will await results from the ongoing global Harmoni-3 trial to determine whether the survival gain and higher bleeding rates apply beyond the China population.

3 ARTICLES

4w ago

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

6 ARTICLES

2mo ago

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

5 ARTICLES

2mo ago

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

6 ARTICLES

3mo ago

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

5 ARTICLES

3mo ago

Japan Grants Conditional Approval to First iPS Cell Therapies for Parkinson’s and Heart Failure

8 ARTICLES

3mo ago

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

15 ARTICLES

3mo ago

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

7 ARTICLES

4mo ago

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

6 ARTICLES

5mo ago

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

5 ARTICLES

5mo ago

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

5 ARTICLES

5mo ago

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

5 ARTICLES

6mo ago

Kyverna CAR-T Delivers Positive Phase 2 Topline in Stiff Person Syndrome as Shares Jump

3 ARTICLES

6mo ago

Zealand Pharma Unveils ‘Metabolic Frontier 2030’ With Targets for Five Launches

3 ARTICLES

6mo ago

Capricor’s HOPE-3 Trial Reports Cardiac and Muscle Gains in Duchenne Muscular Dystrophy

Biotechnology

China Phase 3 Shows 34% Drop in Death Risk for Experimental Lung Cancer Drug

Biogen and Denali Halt BIIB122 Program After Phase 2b Parkinson’s Trial Fails

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

Biocon Targets One in Five Insulin Users as It Pushes for Global Lead

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

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Biotechnology

Japan Grants Conditional Approval to First iPS Cell Therapies for Parkinson’s and Heart Failure

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

Kyverna CAR-T Delivers Positive Phase 2 Topline in Stiff Person Syndrome as Shares Jump

Zealand Pharma Unveils ‘Metabolic Frontier 2030’ With Targets for Five Launches

Capricor’s HOPE-3 Trial Reports Cardiac and Muscle Gains in Duchenne Muscular Dystrophy

Never miss stories about

Biotechnology