FDA

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…]

Apricus says FDA declines to approve erectile dysfunction cream

Apricus says FDA declines to approve erectile dysfunction cream

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…]

U.S. FDA looks to pave way for earlier-stage Alzheimer’s drugs

U.S. FDA looks to pave way for earlier-stage Alzheimer’s drugs

Published 15/02/2018

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…]

FDA clears radioactive drug for cancer that killed Steve Jobs

FDA clears radioactive drug for cancer that killed Steve Jobs

Published 26/01/2018

(Reuters) - The U.S. Food and Drug Administration on Thursday approved a radioactive drug to treat the ultra-rare type of digestive tract cancer that killed [more…]

Valeant says Bausch & Lomb’s over-the-counter eye drop gets FDA nod

Valeant says Bausch & Lomb’s over-the-counter eye drop gets FDA nod

Published 22/12/2017

A sign for the headquarters of Valeant Pharmaceuticals International Inc is seen in Laval, Quebec June 14, 2016. REUTERS/Christinne Muschi/File Photo(Reuters) - Canadian drugmaker Valeant [more…]