FDA

Akcea Therapeutics genetic disease treatment gets FDA approval

Akcea Therapeutics genetic disease treatment gets FDA approval

Published 05/10/2018

(Reuters) - Akcea Therapeutics Inc said on Friday its treatment, developed along with Ionis Pharmaceuticals , which targets a rare genetic disease was approved by [more…]

Antares Pharma’s testosterone drug gets FDA approval

Antares Pharma’s testosterone drug gets FDA approval

Published 01/10/2018

(Reuters) - The U.S. Food and Drug Administration on Monday approved Antares Pharma Inc’s injectable drug to treat low testosterone levels in men, the company [more…]

Insmed’s treatment-resistant lung disease drug gets FDA approval

Insmed’s treatment-resistant lung disease drug gets FDA approval

Published 28/09/2018

(Reuters) - The U.S. Food and Drug Administration on Friday approved Insmed Inc’s lead drug to treat a rare, chronic lung disease, making it the [more…]

Sanofi, Regeneron skin cancer drug gets FDA nod

Sanofi, Regeneron skin cancer drug gets FDA nod

Published 28/09/2018

(Reuters) - Sanofi SA said on Friday its skin cancer drug, made in partnership with Regeneron Pharmaceuticals Inc, was approved by the U.S. Food and [more…]

Endo puts Vasostrict case against U.S. FDA on hold

Endo puts Vasostrict case against U.S. FDA on hold

Published 24/09/2018

(Reuters) - Endo International Plc on Monday said it would stay its lawsuit against the U.S. Food And Drug Administration until the end of the [more…]

Boston Scientific’s drug-coated stent gets FDA approval

Boston Scientific’s drug-coated stent gets FDA approval

Published 24/09/2018

(Reuters) - The U.S. Food and Drug Administration on Monday approved Boston Scientific Corp’s drug-coated stent Eluvia to treat narrowed arteries in the leg. The [more…]

FDA approves Teva’s generic of Mylan’s EpiPen

FDA approves Teva’s generic of Mylan’s EpiPen

Published 18/08/2018

(Reuters) - The U.S. Food and Drug Administration on Thursday approved Teva Pharmaceutical Industries Ltd’s generic version of Mylan NV’s life-saving allergy injection, EpiPen, at [more…]

Japan’s Eisai sets price tag of about $17,000 on liver cancer drug…

Japan’s Eisai sets price tag of about $17,000 on liver cancer drug…

Published 17/08/2018

(This version of the August 16th story corrects to change drug price in headline, first bullet, paragraphs 1 and 3 after company corrects it to [more…]

FDA declines to approve Insys Therapeutic’s opioid painkiller

FDA declines to approve Insys Therapeutic’s opioid painkiller

Published 27/07/2018

(Reuters) - Insys Therapeutics Inc said on Friday the U.S. Food and Drug Administration declined to approve its opioid painkiller, citing potential safety concerns. Insys [more…]

FDA staff raises efficacy doubts on GSK’s lung disease treatment

FDA staff raises efficacy doubts on GSK’s lung disease treatment

Published 23/07/2018

(Reuters) - U.S. Food and Drug Administration staff reviewers have raised doubts over the effectiveness of GlaxoSmithKline Plc’s drug Nucala in treating a disease that [more…]