INVOKANA® is the only diabetes medicine indicated to slow the progression of diabetic nephropathy (also known as DKD) and reduce the risk of hospitalization for heart failure in patients with T2D and DKD
Rituxan is the first and only FDA-approved treatment for pediatric patients 2 years of age and older living with granulomatosis with polyangiitis or microscopic polyangiitis
The U.S. Food and Drug Administration today approved Rituxan (rituximab) injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2 years of age and older in combination with glucocorticoids (steroid hormones).
Approval represents first and only FDA-approved biologic indicated for newly diagnosed patients who are eligible for a stem cell transplant
The U.S. Food and Drug Administration today expanded the approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve).
MC2 Therapeutics, a late clinical-stage pharmaceutical company focused on novel PAD™ Technology-based topical therapies for chronic inflammatory conditions, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for Wynzora™ Cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) for the treatment of plaque psoriasis.
Abiomed’s (NASDAQ: ABMD) newest heart pump, the Impella 5.5 with SmartAssist, has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days.
Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) headquartered in Hunt Valley, Maryland, is pleased to announce the commercial supply of Fulvestrant Injection 250mg/5ml drug product, which was recently approved by the FDA.
Phoenix Molecular Designs (PhoenixMD), a clinical stage biotechnology company developing precise cancer therapeutics targeting essential kinases, received clearance from the Food and Drug Administration (FDA) for PhoenixMD's Investigational New Drug (IND) application for its proprietary PMD-026.
At the U.S. Food and Drug Administration we are committed to keeping patients, their families and caregivers at the center of our work and to deepening their involvement in how we review medical device applications.
Over the past few years we’ve witnessed new medical breakthroughs that are altering how diseases are treated in ways that seemed unimaginable just a decade ago.
Reneo Pharmaceuticals, a clinical stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to the company's lead drug candidate, REN001, for the treatment of fatty acid oxidation disorders (FAOD).
The U.S. Food and Drug Administration today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise.
Elysium Health, Inc.,™ a life sciences company developing clinically validated health products based on aging research, today announced the acceptance of an Investigational New Drug ("IND") application by the Food and Drug Administration (FDA) to evaluate the efficacy of BASIS™ for the prevention of acute kidney injury (AKI) in surgical cardiac patients.
Sound Pharmaceuticals is pleased to announce that the FDA's Division of Neurology Products has granted its request for Fast Track Designation (FTD) involving SPI-1005 in the treatment of Meniere's Disease (MD).
The Food and Drug Administration (FDA) has awarded Perspectum Inc $250,000 to qualify its proprietary biomarkers for NASH in collaboration with Dr. Naim Alkhouri at the Texas Liver Institute.
Merck Continues to Expand Investigational Supply to Support International Ebola Outbreak Response
Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation (FDA) for the RheOxTM Bronchial RheoplastyTM system.
DreaMed Diabetes achieves unprecedented validation of Advisor Pro, its AI-based insulin recommendations technology
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking first-in-class approval of TREMFYA® (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA).