SANOFI: FDA approves Fluzone® High-Dose Quadrivalent (Influenza Vaccine) for adults 65 years of age and older
Will be available in fall 2020, in time for the 2020-2021 flu season
Latest News
U.S. FDA: Statement on new testing results, including low levels of impurities in ranitidine drugs
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.
SURMODICS: The Surmodics Sundance™ Sirolimus-Coated Balloon Catheter Earns FDA Breakthrough Device Status
Sundance™ Sirolimus-Coated Balloon will receive prioritization throughout the FDA submission and review process to provide patients and physicians timely access to medical devices
HEARTVISTA: Receives FDA 510(k) Clearance for One Click™ Cardiac MRI Package, the First AI-assisted Cardiac MRI Scan Solution
The future of imaging is here—and FDA cleared.
GENETECH: FDA Accepts Genentech’s Biologics License Application for Satralizumab for Neuromyelitis Optica Spectrum Disorder
Satralizumab represents a potential new approach to treating neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating disease often misdiagnosed as multiple sclerosis (MS)
IMPULSE DYNAMICS: Announces U.S. FDA Supplemental-PMA Approval of its Next Generation Optimizer® Smart System
Commercial-Ready Device to Deliver Improved Outcomes to Heart Failure Patients
FDA plans 24 public meetings in November
The U.S. Food and Drug Administration (FDA) has scheduled 24 public meetings, conferences and workshops for November, the agency reported.
DisposeRx helps to eradicate millions of opioid pills
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.
ALKERMES: Biogen and Alkermes Announce FDA Approval of VUMERITY™ (diroximel fumarate) for Multiple Sclerosis
VUMERITY, a New Oral Treatment Option for Relapsing Forms of MS, Offers a Combination of Well-Characterized Efficacy, Safety and Tolerability
Mylan recalls anxiety medication Alprazolam
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.
IMPLANET: Announces FDA 510(k) Clearance for the MADISON Total Knee Prosthesis
Global recognition of the MADISON’s clinical value
HERON THERAPEUTICS: Announces FDA Acceptance of New Drug Application Resubmission for HTX-011 for Management of Postoperative Pain
FDA Sets Prescription Drug User Fee Act (PDUFA) Goal Date of March 26, 2020
ASTELLAS PHARMA: U.S. FDA Grants Fast Track Designation to Astellas for the Development of ASP1128 for Patients at Risk for Acute Kidney Injury
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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MEDICINE360: FDA Approves Medicines360's LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Six Years, the Longest Approved Duration of Use of Any Hormonal IUDs
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.
ALLERGAN PLC: FDA Approves BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Lower Limb Spasticity, Excluding Spasticity Caused by Cerebral Palsy
Approval Marks 11th BOTOX® Therapeutic Indication and Comes 30 Years After the First Indications Were Approved
BLUEWILLOW: Receives FDA Clearance to Begin Phase 1 Study of its Intranasal Anthrax Vaccine
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.
WOLFE EYE CLINIC: U.S. Food & Drug Administration Approves New Wet Age-Related Macular Degeneration Treatment
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
FDA approves first topical minocycline for acne treatment
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.
ALZHEIMER'S ASSOCIATION: Statement Biogen to Submit Aducanumab Results in Early Alzheimer's to U.S. FDA
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: FDA approves Fiasp® for use in insulin infusion pumps for adults with type 1 or type 2 diabetes
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.