USFDA

- 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.
- Read more about AbbVie receives FDA accelerated approval of venclexta™ (venetoclax) tablets
AbbVie announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Venclexta™ (venetoclax) tablets for patients diagnosed with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. The FDA approved this indication under accelerated approval based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial. The FDA approved Venclexta as a first-in-class, oral, once-daily medicine that selectively inhibits the BCL-2 protein. The BCL-2 protein blocks apoptosis (programmed cell death) of cells, including some cancer cells, and can be overexpressed in CLL cells.Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is marketed collaboratively by the companies in the U.S. and by AbbVie outside of the U.S.
- Read more about FDA approves first leadless pacemaker to treat heart rhythm disorders
The U.S. Food and Drug Administration approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart. While the Micra Transcatheter Pacing System works like other pacemakers to regulate heart rate, the self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart.
- Read more about FDA takes steps to withdraw approval of the swine drug carbadox due to safety concerns
U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) took the first step toward rescinding its approval of the use of carbadox to treat swine because the drug may leave trace amounts of a carcinogenic residue.