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 Physicians Committee for Responsible Medicine (PCRM) has filed a petition with the U.S. Food and Drug Administration (FDA) that would require a warning label on all dairy cheese products warning about the potential increased risks of developing breast cancer.
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.
Treatment approved for approximately 90% of patients with cystic fibrosis, many of whom had no approved therapeutic options
Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, today announced that following an End of Phase 2/ Pre-Phase 3 meeting with the United States Food and Drug Administration (FDA), there is agreement regarding the design of a single Phase 3 clinical trial to evaluate the potential of topsalysin as a targeted focal therapy to treat patients with intermediate risk localized prostate cancer.
In the Phase 3 pivotal trial, more than 40 percent of patients receiving STELARA subcutaneous (SC) injections every 8 weeks were in clinical remission at one year and not taking corticosteroids
Neuren Pharmaceuticals (ASX: NEU) announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Neuren’s NNZ-2591 for the treatment of Angelman syndrome, Phelan-McDermid syndrome and Pitt Hopkins syndrome.
Single-dose Xofluza is the first and only antiviral medicine indicated specifically for patients at high risk of developing serious complications from influenza (flu)