Tag: Committee for Medicinal Products for Human Use

January 15, 2019

European Medicines Agency validates Oasmia Pharmaceutical AB’s application to add efficacy data to the approved Apealea

Oasmia Pharmaceutical AB (NASDAQ:OASM) AB today announce that the European Medicines Agency (EMA) has validated a type II variation application...
October 19, 2018

Shire: CHMP Recommends EU Marketing Authorisation of lanadelumab for the Prevention of HAE Attacks

Shire (LSE:SHP, NASDAQ:SHPG), the leading global biotechnology company focused on rare diseases, announced today that the European Medicines Agency’s (EMA)...
June 29, 2018

European CHMP Adopts Positive Opinion for Yescarta (axicabtagene ciloleucel)

Kite, a Gilead Company (Nasdaq:GILD), announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)...
June 29, 2018

Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab)

Bristol-Myers Squibb (NYSE:BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has...
June 29, 2018

Puma Biotechnology Receives Positive CHMP Opinion Recommending Approval of NERLYNX

Puma Biotechnology (Nasdaq:PBYI) announced that on June 28, 2018 the Committee for Medicinal Products for Human Use (CHMP) adopted a...
June 26, 2018

Puma Biotech Receives Positive CHMP Opinion, Spikes Share Price

Puma Biotech released it now has a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of...