FDA

U.S. approves first marijuana plant-derived drug for epilepsy

U.S. approves first marijuana plant-derived drug for epilepsy

Published 26/06/2018

(Reuters) - The U.S. health regulator approved GW Pharmaceuticals Plc’s epilepsy treatment on Monday, making it the first cannabis-based drug to win approval in the [more…]

FDA wants to shorten new drug monopolies to cut costs

FDA wants to shorten new drug monopolies to cut costs

Published 03/06/2018

CHICAGO (Reuters) - In an effort to increase competition and bring down prescription drug prices, FDA Commissioner Dr. Scott Gottlieb wants to speed approval times [more…]

FDA chief outlines new ways to speed cancer drug approvals

FDA chief outlines new ways to speed cancer drug approvals

Published 02/06/2018

CHICAGO (Reuters) - The U.S. Food and Drug Administration is taking steps to streamline the approval process for cancer drugs, reviewing clinical trial data up [more…]

FDA approves Novartis combo therapy for aggressive type of thyroid…

FDA approves Novartis combo therapy for aggressive type of thyroid…

Published 04/05/2018

(Reuters) - The U.S. Food and Drug Administration on Friday approved Novartis AG’s combination therapy to treat an aggressive type of thyroid cancer. The therapy, [more…]

Apricus mulls options- to sell U.S. rights to Vitaros

Apricus mulls options- to sell U.S. rights to Vitaros

Published 16/04/2018

(Reuters) - Apricus Biosciences Inc said on Monday it was considering options for the company and looking to sell the U.S. rights to its erectile [more…]

U.S. FDA restricts sale of Bayer’s Essure birth control device

U.S. FDA restricts sale of Bayer’s Essure birth control device

Published 09/04/2018

(Reuters) - The U.S. Food and Drug Administration (FDA) on Monday slapped restrictions on the sale of Bayer AG’s implanted birth control device Essure, two [more…]

GSK wins new reprieve as Hikma’s generic Advair delayed again

GSK wins new reprieve as Hikma’s generic Advair delayed again

Published 12/03/2018

(Reuters) - GlaxoSmithKline has won a further reprieve for its blockbuster Advair lung drug after U.S. regulators insisted Hikma Pharmaceuticals conduct a further clinical study [more…]

KemPharm’s opioid painkiller gets FDA approval, shares soar

KemPharm’s opioid painkiller gets FDA approval, shares soar

Published 23/02/2018

(Reuters) - KemPharm Inc said on Friday the U.S. Food and Drug Administration approved its opioid painkiller Apadaz for the short-term management of acute pain, [more…]

AstraZeneca’s immunotherapy drug wins key lung cancer approval

AstraZeneca’s immunotherapy drug wins key lung cancer approval

Published 17/02/2018

FILE PHOTO: A sign is seen at an AstraZeneca site in Macclesfield, central England May 19, 2014. REUTERS/Phil Noble/File PhotoLONDON (Reuters) - AstraZeneca’s immunotherapy drug [more…]

Shares of Apricus tank after FDA declines to OK erectile…

Shares of Apricus tank after FDA declines to OK erectile…

Published 16/02/2018

FILE PHOTO: - A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo(Reuters) - [more…]