SUBSCRIBE
SUBSCRIBE

FDA

Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
Drug Development
Heart-Stopping Morning Leads to Vertex Rise As FDA News Sees Positives
May 8, 2015
 · 
3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
AbbVie, Genentech Leukemia Drug Wins Breakthrough Status Tag
May 7, 2015
 · 
3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Business
AcelRx Crashes as the FDA Rejects Request for Meeting on Pain Drug Device
May 4, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
GlaxoSmithKline Slips as FDA Approves Asthma Drug for Adults, Not Younger Patients
May 1, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Amgen’s T-Vec Cancer Therapy Gets FDA Panel OK
April 30, 2015
 · 
3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Kythera Grabs FDA Approval for Chin Fat-Busting Drug
April 30, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Analysts Cheer As Amgen Nabs Long-Awaited FDA Approval of Heart Failure Drug Corlanor
April 16, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Gilead’s Next-Gen HIV Drug Heads to the FDA, Stock Soars
April 8, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
Clovis Oncology Shares Leap as FDA Deems Ovarian Cancer Drug a Breakthrough, Company Preps for ARIEL3
April 7, 2015
 · 
2 min read
FDA
Berry Genomics NextSeq CN500 Instrument And Non-Invasive Prenatal Testing Reagent Kit Receives Chinese FDA Premarket Clearance
March 31, 2015
 · 
2 min read
Load More
PRESS RELEASES
Press Releases
Beren Therapeutics Announces FDA Acceptance of its New Drug Application for Adrabetadex in Infantile-Onset Niemann-Pick Disease Type C
February 23, 2026
 · 
5 min read
Press Releases
Ultragenyx Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application (BLA) for DTX401 AAV Gene Therapy for Glycogen Storage Disease Type Ia (GSDIa)
February 23, 2026
 · 
7 min read
Press Releases
Adial Pharmaceuticals Highlights FDA Policy Direction That May Reduce Pivotal Trial Burden from Two Studies to One
February 23, 2026
 · 
6 min read
Press Releases
Daré Bioscience Announces FDA Clearance of IND for Phase 2 Clinical Study of DARE-HPV, a Potential Treatment for Persistent High-Risk HPV Infection, the Most Common Cause of Cervical Cancer
February 23, 2026
 · 
11 min read
Press Releases
Artios Receives U.S. FDA Fast Track Designation for DNA Polymerase Theta (Polθ) Inhibitor ART6043 for Treatment of gBRCA-mutated HER2-Negative Breast Cancer
February 23, 2026
 · 
4 min read
Press Releases
U.S. FDA Grants Reunion Neuroscience’s Luvesilocin (RE104) Breakthrough Therapy Designation Status
February 23, 2026
 · 
3 min read
Press Releases
Labcorp Expands Collaboration with PathAI to Deploy FDA-Cleared Digital Pathology Platform Nationwide
February 23, 2026
 · 
4 min read
Press Releases
FDA Approves VUEWAY® (gadopiclenol) Solution for Injection, Intravenous Use, for Use in Neonates and Infants
February 23, 2026
 · 
11 min read
Press Releases
Tessera Therapeutics Receives U.S. FDA Fast Track and Orphan Drug Designations for its Lead In Vivo Gene Editing Program TSRA-196 for the Treatment of Adults with AATD
February 23, 2026
 · 
4 min read
Press Releases
Opterion Health AG Announces First Patient enrolled in Phase 1 SPARC Trial Following CTA Approval for OPT101
February 23, 2026
 · 
2 min read
Press Releases
CStone Announces MHRA Approval in UK for Sugemalimab in Stage III NSCLC
February 22, 2026
 · 
6 min read
Press Releases
Savara Announces the U.S. Food and Drug Administration (FDA) Filed the MOLBREEVI* Biologics License Application (BLA) in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
February 22, 2026
 · 
5 min read
Press Releases
Vanda Pharmaceuticals Announces FDA Approval of BYSANTI™ (milsaperidone) for the treatment of Bipolar I Disorder and Schizophrenia - A New Chemical Entity Opening New Horizons in Psychiatric Innovation
February 22, 2026
 · 
11 min read
Press Releases
FDA Clears FluoGuide’s IND for FG001 in High-Grade Glioma; U.S. Clinical Trial Remains on Track
February 22, 2026
 · 
3 min read
Press Releases
U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in Adults
February 22, 2026
 · 
9 min read
Press Releases
Dr. Reddy’s Announces USFDA Acceptance to Review Its Biologics License Application (BLA) for Proposed Interchangeable Biosimilar, Abatacept
February 22, 2026
 · 
5 min read
Press Releases
FDA Approves Genentech’s Venclexta® Plus Acalabrutinib Combination Regimen for Previously Untreated Chronic Lymphocytic Leukemia
February 20, 2026
 · 
17 min read
Press Releases
FDA Accepts New Drug Application for Genentech’s Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer
February 20, 2026
 · 
8 min read
Press Releases
U.S. Food and Drug Administration (FDA) Approves Combination Treatment of VENCLEXTA® (venetoclax) and Acalabrutinib for Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL)
February 20, 2026
 · 
13 min read
Press Releases
FDA accepts New Drug Application for Roche’s giredestrant in ESR1-mutated, ER-positive advanced breast cancer
February 20, 2026
 · 
13 min read
Load More