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RSS FeedPosted by Michael Wonder on 12 Oct 2017
FDA clears first 7T magnetic resonance imaging device
12 October 2017 - Today, the U.S. FDA cleared the first seven tesla (7T) magnetic resonance imaging device, more than ...
Posted by Michael Wonder on 12 Oct 2017
U.S. FDA approves Lyrica CR (pregabalin) extended-release tablets
12 October 2017 - New formulation may offer convenience to patients. ...
Posted by Michael Wonder on 10 Oct 2017
US FDA issues complete response letter for proposed biosimilar pegfilgrastim
10 October 2017 - The U.S. FDA has issued a complete response letter for Mylan´s biologics license application for MYL-1401H, ...
Posted by Michael Wonder on 08 Oct 2017
Athersys to present at 2017 Cell & Gene Meeting on the Mesa and announces regenerative medicine advanced therapy designation from FDA
5 October 2017 - Athersys announced today that Robert W. Mays, Ph.D., Vice President, Regenerative Medicine and Head of Neuroscience ...
Posted by Michael Wonder on 07 Oct 2017
Neurocrine announces FDA approval of 80 mg Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia
5 October 2017 - First and only tardive dyskinesia therapy taken as one capsule, once per day; new 80 mg capsule ...
Posted by Michael Wonder on 07 Oct 2017
Flexion Therapeutics announces FDA approval of Zilretta (triamcinolone acetonide extended-release injectable suspension) for osteoarthritis knee pain
6 October 2017 - Product label also includes positive data from type 2 diabetes study. ...
Posted by Michael Wonder on 07 Oct 2017
FDA approves implantable device to treat moderate to severe central sleep apnea
6 October 2017 - The U.S. FDA today approved a new treatment option for patients who have been diagnosed with ...
Posted by Michael Wonder on 04 Oct 2017
Takeda announces FDA approval of Alunbrig (brigatinib) 180 mg tablets
3 October 2017 - New dosing option will reduce pill burden for patients living with ALK positive non-small-cell lung cancer. ...
Posted by Michael Wonder on 04 Oct 2017
Mylan announces U.S. FDA approval of first generic for Copaxone 40 mg/mL 3-times-a-week and may be eligible for 180-day exclusivity
3 October 2017 - Mylan also receives U.S. FDA approval of generic for Copaxone 20 mg/mL once daily. ...
Posted by Michael Wonder on 04 Oct 2017
FDA approves Botox Cosmetic (OnabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults
3 October 2017 - Botox Cosmetic is the only treatment of its kind approved by the FDA for forehead lines, ...
Posted by Michael Wonder on 30 Sep 2017
Novo Nordisk's new fast-acting mealtime insulin Fiasp approved in the US
29 September 2017 - Novo Nordisk today announced that the US FDA has approved Fiasp (fast-acting insulin aspart), a new ...
Posted by Michael Wonder on 29 Sep 2017
FDA improves access to reports of adverse drug reactions
28 September 2017 - New online tool makes it easier for users to search the FDA Adverse Event Reporting System. ...
Posted by Michael Wonder on 28 Sep 2017
FDA approves new treatment for certain advanced or metastatic breast cancers
28 September 2017 - The U.S. FDA today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human ...
Posted by Michael Wonder on 28 Sep 2017
Intarcia provides corporate update
27 September 2017 - Intarcia receives complete response letter from the FDA for ITCA 650. ...
Posted by Michael Wonder on 28 Sep 2017
Lannett receives FDA approval for oxycodone and acetaminophen tablets, 5 mg/325 mg and 10 mg/325 mg
27 September 2017 - Lannett today announced that it received approval from the U.S. FDA of its abbreviated new drug ...