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BIOMED: Impella® SmartAssist Platform Launches at ESC, Designed to Further Improve Patient Outcomes

Abiomed (NASDAQ: ABMD) announces that the Impella CP® with SmartAssist technology, which is designed to improve patient outcomes with advanced algorithms and simplified patient management, will be commercially available in Europe beginning at the European Society of Cardiology (ESC) Congress 2019 through a controlled roll out process at select sites.

CARSGEN THERAPEUTICS: Receives US FDA Orphan Drug Designation For Fully Human Anti-BCMA (B Cell Maturation Antigen) Autologous Chimeric Antigen Receptor (CAR) T Cells For The Treatment Of Multiple Myeloma

CARsgen Therapeutics Inc., a clinical-stage biopharmaceutical company today announced the United States Food and Drug Administration (FDA) has granted orphan drug designation to its investigational CAR-T cell therapy fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cells (ct053) for the treatment of multiple myeloma.

U.S. FOOD AND DRUG ADMINISTRATION: FDA recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce risk of patient infection

In continued efforts to protect patient safety, FDA orders new postmarket studies for manufacturers, requests real-world contamination rates in duodenoscope labeling and warns about certain test strips illegally marketed to assess duodenoscope cleanliness

EMALEX BIOSCIENCES: Receives FDA Fast Track Designation for Ecopipam for the Treatment of Patients with Tourette Syndrome

Emalex Biosciences, Inc. (Emalex), a biopharmaceutical company developing innovative therapies for patients with neurological and psychiatric conditions, announced today that it has received Fast Track designation for its investigational product, ecopipam, from the U.S. Food and Drug Administration (FDA) for the treatment of patients with Tourette Syndrome (TS).

ELI LILLY & COMPANY: Lilly Receives U.S. FDA Approval for Taltz® (ixekizumab) for the Treatment of Active Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)

Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA).

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.

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

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.

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

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.

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.

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.

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.

FDA Health News