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FDA Acts to Remove Unproven, Potentially Harmful Treatment Used In 'Stem Cell' Centers americanpharmaceuticalreview
August 30, 2017
The U.S. Food and Drug Administration (FDA) took decisive action to prevent the use of a potentially dangerous and unproven treatment belonging to StemImmune in San Diego, California, and administered to patients at the California Stem Cell Treatment Cent
FDA OKs Bard’s Lutonix drug-coated balloon for renal disease complication fiercebiotech
August 29, 2017
The Lutonix drug-coated balloon is now FDA-approved to treat stenosis in the AV fistulae of renal disease patients, which can reduce the number of reinterventions they need to keep up their dialysis treatments.
FDA approves Tandem’s insulin pump with Dexcom CGM integration fiercebiotech
August 29, 2017
With the FDA approval, patients may now view their insulin delivery data and their Dexcom CGM data on one device—Tandem's t:slim X2 insulin pump.
DRL announces the launch of Cefixime in the US expressbpd
August 29, 2017
It is a therapeutic equivalent generic version of Suprax
Jubilant Life gets US FDA nod for anti-inflammatory drug expressbpd
August 29, 2017
Indomethacin capsules are used in the treatment of moderate to severe inflammation and reduce pain
Adamas scores orphan approval for tweaked generic Parkinson's med fiercepharma
August 28, 2017
Adamas' Gocovri is an extended-release formulation of generic amantadine.
After 7 years, EC grants approval for Merck KGaA’s MS drug pharmafile
August 28, 2017
Pharmacovigilance is a science of understanding drug safety through identification, assessment, and prevention of adverse drug reactions (ADRs).
FDA Grants Breakthrough Therapy Designation for Mogamulizumab americanpharmaceuticalreview
August 28, 2017
Kyowa Hakko Kirin announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to their investigational product, mogamulizumab which is being developed for the treatment of Mycosis Fungoides (MF) and Sézary Syn
FDA accepts Roche’s BLA for emicizumab to treat Haemophilia A expressbpd
August 28, 2017
The US Food and Drug Administration (FDA) has accepted Roche’s biologics licence application (BLA) and granted priority review for emicizumab prophylaxis (preventative) to treat patients with haemophilia A with factor VIII inhibitors.
FDA, EMA and EC sign new confidentiality commitment pharmatimes
August 25, 2017
The US Food and Drug Administration can now share non-public and commercially confidential information, including trade secrets relating to medicines inspections, with EU regulators after the parties signed a new commitment.

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