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.
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).
A treatment for peanut allergies took another step toward becoming a reality as the Allergenic Products Committee voted to advise the U.S. Food and Drug Administration (FDA) this month during the approval process.
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.
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.
British American Tobacco CEO Kingsley Wheaton recently released a statement addressing the U.S. Food and Drug Administration’s work to prevent minors from vaping.
The U.S. Food and Drug Administration (FDA) recently awarded a second Breakthrough Device Designation for V-Wave Ltd.’s interatrial shunt for pulmonary arterial hypertension (PAH).
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.
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.
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.
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.
The recall of medications manufactured by Torrent Pharmaceuticals Ltd. to treat high blood pressure conditions has been expanded, the U.S. Food and Drug Administration reported.
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).
Torrent Pharmaceuticals recently announced it was expanding its recall for Losartan potassium tablets and Losartan potassium/hydrochlorothiazide tablets.
Back in June, the U.S. Food and Drug Administration (FDA) released a draft guidance for overhauling the opioid approval process, which one member of the audience said was woefully inadequate.
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 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).
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
More than 70 percent of 200 patients with mild to moderate sleep apnea participating in a Qualtrics Survey conducted September 4 though September 11 selected the FDA-approved Bongo Rx as their preferred choice over a traditional CPAP.
Xarelto has proved to reduce the risk of recurrent venous thromboembolism (VTE), blood clots, in patients who are also suffering from morbid obesity.