This is a pivotal time in the field of gene therapy as the FDA continues its efforts to support innovators developing new medical products for Americans and others around the world.
U.S. FDA: Statement on the Salinas-linked romaine lettuce E. coli O157:H7 outbreak and status update on investigation
Outbreaks declared over, investigation advances, root cause analysis continues
SEATTLE GENETICS: Announces Submission of Tucatinib New Drug Application to the U.S. FDA for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
Submission Based on Positive Pivotal HER2CLIMB Trial Results Recently Presented at the 2019 San Antonio Breast Cancer Symposium and Published in the New England Journal of Medicine
BIOMARIN: Submits Biologics License Application to U.S. Food and Drug Administration for Valoctocogene Roxaparvovec to Treat Hemophilia A
1st Marketing Application Submission in U.S. for Gene Therapy Directed at Any Type of Hemophilia
EVOFEM BIOSCIENCES, INC.: U.S. FDA Acknowledges Receipt of Evofem Biosciences' New Drug Application Resubmission for Amphora® for the Prevention of Pregnancy
Assigns PDUFA Goal Date of May 25, 2020
U.S. FDA: FDA takes efforts to improve quality of compounded drugs from outsourcing facilities through collaboration and education as part of new Center of Excellence
Compounded drugs can serve an important role in meeting patients’ medical needs that cannot be met by an FDA-approved drug.
U.S. FDA: FDA clears first fully disposable duodenoscope, eliminating the potential for infections caused by ineffective reprocessing
The U.S. Food and Drug Administration cleared for marketing in the U.S. the first fully disposable duodenoscope.
In Phase 2b development for the treatment of life-threatening fungal infections
3D SYSTEMS: Expands its Industry-Leading Portfolio of Dental Materials with Newly FDA-Cleared NextDent® Denture 3D+
Dental labs and clinics can produce dentures 75% faster with 90% lower cost using 3D Systems' Digital Denture Workflow
GENETECH: FDA Accepts Genentech’s Biologics License Application for Satralizumab for Neuromyelitis Optica Spectrum Disorder
Satralizumab represents a potential new approach to treating neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating disease often misdiagnosed as multiple sclerosis (MS)
Fulfilling its pledge to remove millions of opioid pills from the medicine cabinets of American homes, DisposeRx recently donated over 150,000 packets of its non-toxic, safe solution for the disposal of unused or expired medications to 140 community partners in 43 states through its community outreach program.
HERON THERAPEUTICS: Announces FDA Acceptance of New Drug Application Resubmission for HTX-011 for Management of Postoperative Pain
FDA Sets Prescription Drug User Fee Act (PDUFA) Goal Date of March 26, 2020
BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, today announces that the U.S. Food and Drug Administration (FDA) has approved Fast Track Designation for bemcentinib for the treatment of elderly patients with acute myeloid leukaemia (AML) whose disease has relapsed.
AMERICAN GENE TECHNOLOGIES: IND Application Submission To FDA For Phase 1 Trial Of Genetically Modified Autologous Cell Therapy For HIV Announced by American Gene Technologies
Progress Toward the Goal of Achieving a Functional Cure for HIV Disease
Hackensack Meridian Health has invested $1 million in a comprehensive strategy to curb the vaping epidemic through its "Take Vape Away" campaign.
BOEHRINGER INGELHEIM: FDA Grants Ofev® Breakthrough Therapy Designation for Chronic Fibrosing ILDs with a Progressive Phenotype
The designation was supported by results from the Phase III INBUILD® study that met its primary endpoint and was recently published in the New England Journal of Medicine
EICOSIS: Announces FDA Acceptance of IND Application for EC5026, the First Soluble Epoxide Hydrolase Inhibitor to Treat Pain
EicOsis LLC, a pharmaceutical startup developing a new class of oral non-narcotic analgesics, announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate Phase 1 clinical trials for their drug candidate, EC5026, for the treatment of pain.