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US FDA approves Emflaza tablets to treat patients with DMD pharmaceutical-technology
February 14, 2017
The US Food and Drug Administration (FDA) has approved Emflaza (deflazacort) tablets and oral suspension to treat patients with Duchenne muscular dystrophy (DMD).
FDA Approves Drug to Treat Duchenne Muscular Dystrophy americanpharmaceuticalreview
February 13, 2017
The U.S. Food and Drug Administration has approved Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 years and older with Duchenne muscular dystrophy (DMD),
US FDA approves Amgen’s Parsabiv to treat HPT in adult patients pharmaceutical-technology
February 10, 2017
Amgen research and development executive vice-president Sean Harper said: "We are excited about today's approval of Parsabiv in the US and the opportunity to provide patients and health care providers with a novel option to help treat a complex disease th
FDA Grants Fast Track Designation To Angionetics’ Generx Product Candidate, A One-Time Gene Therapy firstwordpharma
February 08, 2017
Angionetics Inc. reported that the FDA has granted Fast Track designation for the Phase 3 clinical investigation of Generx [Ad5FGF-4] cardiovascular angiogenic gene therapy...
FDA Grants Abbott the First Commercial Authorization for a Molecular Test to Detect Zika Virus Using americanpharmaceuticalreview
February 06, 2017
Abbott has announced that the U.S. Food and Drug Administration (FDA) has authorized its molecular test, the Abbott RealTime ZIKA test, to detect Zika virus in whole blood (when collected alongside a patient-matched serum or plasma sample) for emergency u
FDA confirms elevated levels of belladonna in certain homeopathic teething products FDA
January 27, 2017
The U.S. Food and Drug Administration announced today that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label.
NARCAN (naloxone HCl) Nasal Spray 2mg Approved by U.S. Food and Drug Administration (FDA) firstwordpharma
January 26, 2017
Adapt Pharma to provide 2mg as an additional dosing option for naloxone nasal spray
Working Together to Reduce the Devastating Effects of Opioid Misuse FDA
January 25, 2017
The public health crisis of opioid misuse, addiction and overdose is one of the most challenging issues the U.S. Food and Drug Administration has faced during my time as FDA commissioner. Solving this issue is critical to our future.
J&J's Imbruvica scores fifth FDA lymphoma approval pharmafile
January 23, 2017
Johnson & Johnson’s Imbruvica (ibrutinib) has scored its fifth indication approval in the US for the treatment of Marginal Zone Lymphoma (MZL), this time in patients who require systemic therapy and have received at least one prior anti-CD20-based therapy
FDA Approves IMBRUVICA® as First Treatment Specifically Indicated for Relapsed/Refractory Marginal Z americanpharmaceuticalreview
January 20, 2017
AbbVie has announced that the U.S. Food and Drug Administration (FDA) approved IMBRUVICA® (ibrutinib) for the treatment of patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who require systemic therapy and have received at least one pri

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