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US WORLDMEDS: FDA Approves US WorldMeds' MYOBLOC® (rimabotulinumtoxinB) Injection for Chronic Sialorrhea
MYOBLOC is the only approved botulinum toxin for chronic sialorrhea that provides significant results in as early as one week(1),(2)
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Eylea Injection Prefilled Syringe approved by FDA
The Eylea Injection Prefilled Syringe received the Chemistry, Manufacturing and Controls Prior-Approval Supplement by the Food and Drug Administration (FDA), according to a statement released by Regeneron Pharmaceuticals Inc.
Islaroxime receives FDA Fast Track Designation
The U.S. Food and Drug Administration (FDA) granted its Fast Track Designation to islaroxime, which is used for the treatment of acute heart failure. Islaroxime was developed by Windtree Therapeutics Inc., a biotechnology and medical device company.
SAREPTA THERAPEUTICS: Receives Complete Response Letter from the US Food and Drug Administration for Golodirsen New Drug Application
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) seeking accelerated approval of golodirsen injection for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping.
FDA Update: June facility inspection results
The U.S. Food and Drug Administration inspects numerous facilities around the nation to ensure that they comply with current rules governing FDA-regulated products.
CERECOR: Receives Fast Track Designation from FDA for CERC-802 for the Treatment of Mannose-Phosphate Isomerase Deficiency
Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases in pediatrics and neurology, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CERC-802, an ultra-pure, oral formulation of D-mannose currently in development for the treatment of Mannose-Phosphate Isomerase Deficiency, also known as MPI-CDG or CDG-1b.
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VERTEX PHARMACEUTICALS: FDA Accepts New Drug Application for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Combination Treatment
FDA Grants Priority Review of the application and sets a PDUFA target action date of March 19, 2020
MCKESSON: ROZLYTREK™ (entrectinib), FDA Approved for Hard-to-Treat NTRK Fusion-Positive Tumors, Available at Biologics by McKesson
Biologics by McKesson, an independent specialty pharmacy for oncology and other rare and complex therapeutic areas, was selected by Genentech as a specialty pharmacy provider for ROZLYTREK™ (entrectinib) for the treatment of hard-to-treat and rare NTRK fusion-positive tumor
ASTELLAS PHARMA, INC.: U.S. FDA Grants XTANDI® (enzalutamide) Application Priority Review for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer
XTANDI Supplemental New Drug Application (sNDA) Seeks to Add an Indication for Men with Prostate Cancer that Has Spread but Is Sensitive to Hormone Therapy
EIGER BIOPHARMACEUTICALS, INC.: Announces FDA Breakthrough Therapy Designation for Peginterferon Lambda for Treatment of Hepatitis Delta Virus Infection
Fourth Eiger Program Granted Breakthrough Therapy Designation
CASSIOPEA: Announces FDA Submission of New Drug Application for Clascoterone Cream 1%, the First New Mechanism of Action for Acne in Nearly 40 Years
Cassiopea SpA (SIX: SKIN), a specialty pharmaceutical company developing and commercializing prescription drugs with novel mechanisms of action (MOA) to address long-standing and essential dermatological conditions, announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for clascoterone cream 1% for the treatment of acne.
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new antibiotic to treat community-acquired bacterial pneumonia
The U.S. Food and Drug Administration today approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.
NABRIA THERAPEUTICS: Receives U.S. FDA Approval of Xenleta™ (lefamulin) to Treat Community-Acquired Bacteria Pneumonia (CABP)
Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that the U.S. Food and Drug Administration (FDA) has approved Nabriva’s new drug applications for the oral and intravenous (IV) formulations of Xenleta™ (lefamulin) for the treatment of community-acquired bacterial pneumonia (CABP) in adults.
MODERNA: Receives FDA Fast Track Designation for Zika Vaccine mRNA-1893
Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational Zika vaccine (mRNA-1893) currently being evaluated in a Phase 1 study for the prevention of Zika virus infection in healthy adults.
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
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
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.