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.
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).
Back in June, the U.S. Food and Drug Administration (FDA) released a draft guidance for overhauling the opioid approval process, which one member of the audience said was woefully inadequate.
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.
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).
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.
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.
Eli Lilly and Co. was recently accepted into the U.S. Food and Drug Administration’s (FDA) Complex Innovative Trial Designs (CID) Pilot Meeting Program.
Omega Laboratories Limited, a Canadian-based subsidiary of Nichi-Iko Pharmaceutical Co., Ltd., and Sagent Pharmaceuticals, Inc., recently passed its initial Food and Drug Administration (FDA) Establishment Inspection Report and will now be allowed to manufacture FDA-approved products.
The treatment involves taking Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, which is called SSc-ILD.
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).
The Center for Responsible Science (CRS) said it is shocking that the Federal Drug Administration (FDA) granted fast-track approval for a nasal spary based on a two-day study of 30 trial participants because it was fast-acting and later declined to label the drug fast-acting on approval.
First approval for Xeris is based on positive efficacy and safety results from multiple clinical studies
Filing includes data from two Phase 3 trials which evaluated the safety and efficacy of Abicipar quarterly dosing regimen
Once daily Aczone® 7.5% Gel is proven to treat acne vulgaris in 12 week clinical studies