USFDA

- Read more about FDA Grants Advaxis Fast Track Designation for ADXS-HER2
Advaxis, Inc. announced that the Food and Drug Administration (FDA) has granted Fast Track Designation for the company’s immunotherapy product candidate ADXS-HER2 for patients with newly-diagnosed, non-metastatic, surgically-resectable osteosarcoma.
- Read more about FDA accepts resubmission of new drug application for RAYALDEE®
OPKO Health, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted OPKO's resubmission on April 22, 2016 of the New Drug Application (NDA) for RAYALDEE® (calcifediol) for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
- Read more about Aurobindo Pharma receives USFDA approval for famotidine tablets (OTC)
Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Famotidine Tablets USP, 10 mg and 20 mg (OTC). This product is expected to be launched in Q2 FY16-17.
- Read more about Collegium Receives FDA Approval for Xtampza™ ER
Collegium Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Xtampza™ ER (oxycodone) extended-release (ER) capsules CII, a twice-daily, oxycodone medication for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
- Read more about Intuity Medical receive US FDA nod to market POGO Automatic Blood Glucose Monitoring System
The US Food and Drug Administration (FDA) has granted marketing approval for Intuity Medical's POGO Automatic Blood Glucose Monitoring System.The POGO System is the first blood glucose meter and multi-test cartridge to provide automatic testing with lancing, blood collection and analysis in one easy step. By combining all of the necessary blood glucose testing supplies into a convenient, self-contained 10-test cartridge, POGO provides ease of use and discretion for millions of patients who need to regularly test their blood glucose in the management of their diabetes.

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- Read more about AM-Pharma receives FDA fast track designation for recAP in Acute Kidney Injury
AM‐Pharma B.V., a biopharmaceutical company focused on the development of recAP (recombinant human Alkaline Phosphatase) for inflammatory diseases, announces that it has received fast track designation from the U.S. Food and Drug Administration (FDA) for recAP to treat Acute Kidney Injury (AKI). Additionally, the Company reports that the interim analysis on the first stage of the adaptive Phase II trial in AKI has been successfully completed.
- Read more about Bevespi Aerosphere™ approved by the US FDA for patients with COPD
Astrazeneca announced that the US Food and Drug Administration has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
- Read more about U.S. FDA approved iron replacement product for treating Anemia
Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that the U.S. Food & Drug Administration (FDA) has approved the New Drug Application for Triferic Powder Packet for commercial sale as an iron replacement product to maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease. Triferic is the Company's innovative iron-replacement drug for the treatment of anemia in chronic kidney disease patients receiving hemodialysis.
- Read more about Emergent BioSolutions submits sBLA for FDA approval of large-scale manufacturing of BioThrax in building 55
Emergent BioSolutions Inc. announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of the manufacture of BioThrax® (Anthrax Vaccine Adsorbed) in Building 55, the company’s large-scale manufacturing facility. The sBLA is supported by data that demonstrate that BioThrax manufactured at large scale in Building 55 is comparable to BioThrax manufactured in the currently-licensed facility. This submission follows the company’s successful completion of the re-analysis of data from one of more than 30 comparability assays for BioThrax manufactured in the new facility as requested by FDA.
- Read more about U.S. FDA accepts for priority review Bristol-Myers Squibb’s sBLA for opdivo®
Bristol-Myers Squibb’s announced that the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA), which seeks to expand the use of Opdivo to patients with classical Hodgkin lymphoma (cHL) after prior therapies.