Zacks.com on MSN1d
FDA Clears Allogene's IND for CAR T Therapy in Autoimmune Diseases
Allogene Therapeutics, Inc. ALLO announced that the FDA has cleared its investigational new drug (IND) application to begin ...
Eagle-Tribune1d
Gameto Announces FDA IND Clearance for Fertilo, the First iPSC-Based Therapy to Enter U.S. Phase 3 Clinical Trials
Gameto, a clinical-stage biotech company developing iPSC-based therapies for women’s health, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug ...
Allogene announces FDA cleared IND application for study of ALLO-329
Allogene Therapeutics (ALLO) announced that the U.S. Food and Drug Administration, FDA, has cleared its Investigational New Drug, IND, ...
The Bakersfield Californian4d
Ocugen, Inc. Announces Investigational New Drug Application in Effect After Review by FDA to ...
has reviewed the Company’s Investigational New Drug (IND) application and it is in effect. This is a critical step toward the initiation of the Phase 1 clinical trial for OCU500—an inhaled ...
Morningstar9d
Atara's New Drug Applications Placed on Hold by FDA
Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on ...
Business Wire13d
Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...
BioSpace2d
Atara to Cut Half Its Workforce Following FDA-Related Setbacks
Atara Biotherapeutics’ layoffs could leave the biotech with around 80 employees. The cuts follow news that the FDA rejected ...
Enveric Biosciences Receives Notice of Allowance for Lead Drug Candidate EB-003 from United States Patent and Trademark Office
Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of ...
New Atlas13d
Got milk? Startup develops milk-based targeted drug-delivery technology
A couple of University of Nebraska professors have launched a startup company with the goal of bringing to market an ...
SEED receives FDA Rare Pediatric Disease, Orphan Drug designations for ST-01156
SEED Therapeutics announced that the U.S. Food and Drug Administration has granted Rare Pediatric Disease and Orphan Drug designations to ...
Managed Healthcare Executive7d
FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines ...
Atara's New Drug Applications Placed on Hold by FDA
Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on its ...