CELGENE CORPORATION: U.S. FDA Approves INREBIC® (Fedratinib) as First New Treatment in Nearly a Decade for Patients With Myelofibrosis
INREBIC provides new, once-daily oral option for patients affected by rare bone marrow cancer
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ZIMMER BIOMET HOLDINGS, INC.: Zimmer Biomet's Innovative Treatment for Young Patients with Scoliosis Receives FDA Approval
The Tether™ represents the first approval order for a humanitarian use device in spinal pediatrics within the last 15 years
CVRX, INC.: CVRx Receives FDA Approval for World's First Heart Failure Neuromodulation Device
BAROSTIM™ NEO provides significant clinical benefit to heart failure patients
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U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new device to improve symptoms in patients with advanced heart failure
The U.S. Food and Drug Administration approved the Barostim Neo System for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronization therapy.
U.S. FOOD AND DRUG ADMINISTRATION: FDA expands indication for several transcatheter heart valves to patients at low risk for death or major complications associated with open-heart surgery
The U.S. Food and Drug Administration approved an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis (a narrowing of the heart’s aortic valve that restricts blood flow to aorta, the body’s main artery) who are at low risk for death or major complications associated with open-heart surgery to replace the damaged valves.
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U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first of its kind device to treat pediatric patients with progressive idiopathic scoliosis
The U.S. Food and Drug Administration today approved the first spinal tether device intended to be used in children and adolescents to correct the most common form of scoliosis, called idiopathic scoliosis, that has not responded to conservative treatment options, such as external bracing.
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.
Jeff Berg Assumes Top Leadership Role at AbelsonTaylor With Appointment to President
Founder Dale Taylor Will Remain CEO and Chairman of the Board
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
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)
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.
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.