U.S. FOOD AND DRUG ADMINISTRATION: FDA approves treatment for patients with rare bone marrow disorder
Today, the U.S. Food and Drug Administration approved Inrebic (fedratinib) capsules to treat adult patients with certain types of myelofibrosis.
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FDA sends enforcement letter to Aclaris Therapeutics over Eskata advertising
The Food and Drug Administration Office of Prescription Drug Promotion recently sent a letter to Aclaris due to false or misleading claims for its direct-to-consumer advertising for Eskata.
Conference on Tobacco and Nicotine Products Regulation set for Oct. 24-25
The Tobacco and Nicotine Products Regulation and Policy Conference will take place Oct. 24-25.
AbelsonTaylor clears a path for AI to take hold in health care
The pharmaceutical industry is looking at artificial intelligence (AI) to have a major impact on the future of medicine as relationships between pharma corporations and AI researchers are already flourishing in the hopes of one day providing a faster and more reliable digital health care service to patients around the nation.
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor
FDA also approves drug for second indication in a type of lung cancer
FDA Update: generic drug approvals
The U.S. Food and Drug Administration periodically provides information on the pace of generic drug approvals through its website.
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new drug for treatment-resistant forms of tuberculosis that affects the lungs
Approval marks the second drug approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs and signals FDA’s continued focus on facilitating development of new treatments to fight antimicrobial resistant infections
BINX HEALTH: Receives FDA 510(k) Clearance For Rapid Point Of Care Platform For Women's Health
binx io enables first-ever "test-and-treat" paradigm with sample to answer in 30 minutes for the two most tested-for sexually transmitted infections (STIs)
FDA approves proactive-HF pivotal trial for Cordella Sensor
The multi-center PROACTIVE-HF trial of the Cordella Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor) has been approved by the Food and Drug Administration (FDA). The point of the trial is to expedite pre-market approval (PMA) of the Cordella Sensor and provide evidence to the Centers for Medicare & Medicaid Services (CMS).
FDA clears tests for new indications of Lyme disease
Diagnosing Lyme disease is notoriously difficult, so the announcement from the Food and Drug Administration (FDA) that four cleared tests with new indications are now cleared for marketing brings hope to the many who suffer from the disease.
DYNACURE: Receives Orphan Drug Designation from the US FDA for DYN101, an Antisense Medicine to Treat Rare Disease 'Centronuclear Myopathies'
Company expects to initiate Phase 1 / 2 study 'Unite-CNM' in 2H2019
BAUSCH HEALTH: Ortho Dermatologics Announces U.S. FDA Filing Acceptance For IDP-123 Treatment For Acne Vulgaris In Lotion Form
Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for IDP-123 (tazarotene 0.045%) Lotion with a PDUFA action date of Dec. 22, 2019.
VESSELON: Acquires FDA-Approved Lipid Microsphere Drug Imagent® For Therapeutic Platform
Vesselon (www.vesselon.com), an oncology therapeutics company, announced the acquisition of an FDA-approved drug Imagent®. Vesselon will use Imagent to create novel therapeutic complexes in four classes of cancer drugs: cytokines, oncolytic viruses, monoclonal antibodies, and nucleic acid constructs.
FDA Update: July medical device recalls
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.
MCKESSON: TURALIO™ (pexidartinib), FDA Approved Treatment of TGCT, Available at Biologics by McKesson
Exclusive distribution agreement with Daiichi Sankyo, Inc. expands rare disease and complex therapeutic specialty pharmacy needs
BLUEPRINT MEDICINES: Announces FDA Acceptance of New Drug Application for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST
FDA grants priority review and sets PDUFA date for February 14, 2020
STOKE THERAPEUTICS: Granted FDA Orphan Drug Designation for STK-001, an Investigational New Treatment for Dravet Syndrome
Stoke Therapeutics, Inc., (Nasdaq: STOK), a biotechnology company pioneering a new way to treat the underlying cause of genetic diseases by precisely upregulating protein expression, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its lead product candidate, STK-001, an investigational new treatment for Dravet syndrome.
U.S. FOOD AND DRUG ADMINISTRATION: Statement on data accuracy issues with recently approved gene therapy
As a public health agency, we believe that it is critical to facilitate the development of innovative safe and effective medical products, like the cellular and gene therapy products that have shown enormous potential to treat previously untreatable diseases.
FOAMIX PHARMACEUTICALS: Foamix Submits New Drug Application to U.S. FDA for FMX103 for the Treatment of Moderate-to-Severe Papulopustular Rosacea
Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for FMX103 for the treatment of moderate-to-severe papulopustular rosacea in patients 18 years of age and older.