Americans deserve to have confidence in the quality of drugs the U.S. Food and Drug Administration regulates – from the prescription medicines they take to the over-the-counter (OTC) products they use in their daily lives.
Sundance™ Sirolimus-Coated Balloon will receive prioritization throughout the FDA submission and review process to provide patients and physicians timely access to medical devices
The future of imaging is here—and FDA cleared.
Satralizumab represents a potential new approach to treating neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating disease often misdiagnosed as multiple sclerosis (MS)
Commercial-Ready Device to Deliver Improved Outcomes to Heart Failure Patients
Fulfilling its pledge to remove millions of opioid pills from the medicine cabinets of American homes, DisposeRx recently donated over 150,000 packets of its non-toxic, safe solution for the disposal of unused or expired medications to 140 community partners in 43 states through its community outreach program.
VUMERITY, a New Oral Treatment Option for Relapsing Forms of MS, Offers a Combination of Well-Characterized Efficacy, Safety and Tolerability
Mylan Pharmaceuticals Inc. is carrying out a voluntary nationwide recall of one lot of Alprazolam Tablets, USP C-IV 0.5 mg, due to the potential presence of a foreign substance.
Global recognition of the MADISON’s clinical value
FDA Sets Prescription Drug User Fee Act (PDUFA) Goal Date of March 26, 2020
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of ASP1128 for patients at increased risk of developing moderate to severe acute kidney injury (AKI) after coronary artery bypass and/or valve (CABG/V) surgery.
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Medicines360, a global nonprofit organization with a mission to expand women's access to quality medicines, and Allergan plc (NYSE: AGN), a leading global pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved Medicines360's Supplemental New Drug Application (sNDA) to extend the duration of use of LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to six years.
Approval Marks 11th BOTOX® Therapeutic Indication and Comes 30 Years After the First Indications Were Approved
BlueWillow Biologics®, a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for BW-1010, the company's next-generation anthrax vaccine candidate.
The highly anticipated approval of Beovu® (brolucizumab) may reduce the frequency of intravitreal injections for wet age-related macular degeneration patients following clinical trials at Wolfe Eye Clinic
The U.S. Food and Drug Administration (FDA) has approved AMZEEQTM (minocycline) topical foam, 4 percent. Manufactured by Foamix Pharmaceuticals Ltd., AMZEEQ, formerly known as FMX101, is the first topical minocycline to be approved by the FDA for any condition.
On behalf of the more than 5 million Americans living with Alzheimer's and their family members, the Alzheimer's Association is encouraged to learn that Biogen will pursue regulatory approval from the FDA for the investigational drug aducanumab based on Phase 3 clinical trial results from the EMERGE and ENGAGE studies, and other related data, after finding a reduction of cognitive and functional decline in people taking the high dose.
Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has expanded the label for Fiasp® (insulin aspart injection) 100 u/mL to include use in insulin infusion pumps for the improvement of glycemic control in adults with type 1 or type 2 diabetes.1 Fiasp®, a rapid-acting insulin, was approved by the FDA in 2017 for use by intravenous infusion under supervision by a healthcare professional or by subcutaneous multiple daily injection (MDI) in adults with diabetes.
The U.S. Food and Drug Administration's (FDA) National Center for Toxicological Research (NCTR) awarded a multi-year contract to Xybion, a software and consulting firm that will aid in expediting research of new products and medicines.
BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, today announces that the U.S. Food and Drug Administration (FDA) has approved Fast Track Designation for bemcentinib for the treatment of elderly patients with acute myeloid leukaemia (AML) whose disease has relapsed.