ONTOZRY™ (cenobamate) receives positive CHMP opinion for the adjunctive treatment of uncontrolled focal onset seizures in adults*
January 29, 2021 12:20 ET
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Arvelle Therapeutics
Positive CHMP opinion is an important milestone for Arvelle Therapeutics and cenobamate When approved, cenobamate will provide new hope in helping adult patients with uncontrolled focal epilepsy move...
Pfizer und BioNTech erhalten positive CHMP-Empfehlung für ihren COVID-19-Impfstoff
December 21, 2020 09:18 ET
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BioNTech SE
Entscheidung der Europäischen Kommission zur bedingten Marktzulassung wird in Kürze erwartetPositive Beurteilung des CHMP folgt auf Erteilung mehrerer Notfallzulassungen auf der ganzen Welt; das...
Pfizer and BioNTech Receive CHMP Positive Opinion for their COVID-19 Vaccine
December 21, 2020 09:18 ET
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BioNTech SE
European Commission decision on conditional marketing authorization expected imminentlyPositive CHMP opinion follows several emergency use authorizations worldwide; committee reviewed totality of...
Biofrontera provides clinical development updates
February 19, 2020 05:45 ET
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Biofrontera AG
Leverkusen, Germany, Feb. 19, 2020 (GLOBE NEWSWIRE) -- Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the “Company”), an international biopharmaceutical company, today provides an...
European Medicines Agency recommends indication expansion of Ameluz® for treatment of actinic keratoses on the extremities and trunk/neck
February 03, 2020 05:45 ET
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Biofrontera AG
Leverkusen, Germany, Feb. 03, 2020 (GLOBE NEWSWIRE) -- Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the “Company”), an international biopharmaceutical company, announced today that...
Shire plc: CHMP Recommends EU Marketing Authorisation of lanadelumab for the Prevention of HAE Attacks
October 19, 2018 08:00 ET
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Shire plc
CHMP Recommends EU Marketing Authorisation of lanadelumab for the Prevention of HAE Attacks - If approved, lanadelumab would be the first monoclonal antibody for the preventive treatment of...
TESARO Receives Positive CHMP Opinion for ZEJULA®
September 15, 2017 07:45 ET
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TESARO, Inc.
ZUG, Switzerland, Sept. 15, 2017 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the European Medicines Agency’s (EMA) Committee...
TESARO Receives Positive CHMP Opinion for VARUBY®
February 27, 2017 02:00 ET
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TESARO, Inc.
WALTHAM, Mass., Feb. 27, 2017 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the European Medicines Agency’s (EMA) Committee for...