ONTOZRY™ (cenobamate) receives positive CHMP opinion for the adjunctive treatment of uncontrolled focal onset seizures in adults*
29 janv. 2021 12h20 HE
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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
21 déc. 2020 09h18 HE
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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
21 déc. 2020 09h18 HE
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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
19 févr. 2020 05h45 HE
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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
03 févr. 2020 05h45 HE
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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
19 oct. 2018 08h00 HE
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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®
15 sept. 2017 07h45 HE
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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®
27 févr. 2017 02h00 HE
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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...