BioNTech and Pfizer Initiate Rolling Submission to European Medicines Agency for SARS-CoV-2 Vaccine Candidate BNT162b2
October 06, 2020 05:01 ET
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BioNTech SE
Rolling review accepted by the EMA based on available preclinical and clinical data for BNT162b2 to dateBioNTech and Pfizer will continue regular and open dialogue with the EMA providing results from...
Corbus Pharmaceuticals Reports Last Subject Visit in Phase 2b Study of Lenabasum for Treatment of Cystic Fibrosis
June 22, 2020 08:05 ET
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Corbus Pharmaceuticals Holdings, Inc.
Topline data on schedule for Q3 2020Reduction in pulmonary exacerbations (PEx) as primary endpoint Study enrolled 426 participants regardless of CFTR mutation or background CFTR-targeting...
BeiGene Announces European Medicines Agency Acceptance of its Marketing Authorization Application for BRUKINSA® (Zanubrutinib) for the Treatment of Patients with Waldenström’s Macroglobulinemia
June 18, 2020 07:30 ET
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BeiGene, LTD.
CAMBRIDGE, Mass. and BEIJING, China, June 18, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing...
Även europeiska läkemedelsmyndigheten positiv till Corlines planerade fas 2-studie
April 08, 2020 07:13 ET
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Corline Biomedical AB
Den 11 mars 2020 var Corline inbjudet till rådgivningsmöte (Protocol Assistance) med den europeiska läkemedelsmyndigheten EMA för att diskutera bolagets planerade fas 2-studie för Renaparin®. Bolaget...
SUNSTOCK, INC. ANNOUNCES FULL SETTLEMENT OF ALL OUTSTANDING CONVERTIBLE DEBTS
February 18, 2020 09:00 ET
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Sunstock, Inc.
SACRAMENTO, CA, Feb. 18, 2020 (GLOBE NEWSWIRE) -- Sunstock, Inc. (“Sunstock” or the “Company”) (OTC Pink: SSOK) announces the full settlement of all corporate outstanding convertible debts. Thus,...
L'agence européenne du médicament accepte le dossier de demande d'enregistrement réglementaire de Lumoxiti dans la leucémie à tricholeucocytes en rechute ou réfractaire
January 02, 2020 01:00 ET
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INNATE PHARMA
Innate Pharma SA (Euronext Paris : IPH – ISIN : FR0010331421 ; Nasdaq : IPHA) (« Innate » ou la « Société ») annonce aujourd’hui que l’Agence Européenne du Médicament (EMA) a accepté le dossier de...
The European Medicines Agency accepts the regulatory submission for Lumoxiti in relapsed or refractory hairy cell leukemia
January 02, 2020 01:00 ET
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INNATE PHARMA
Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization...
The European Medicines Agency Accepts the Regulatory Submission for Lumoxiti in Relapsed or Refractory Hairy Cell Leukemia
January 02, 2020 01:00 ET
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INNATE PHARMA
MARSEILLE, France, Jan. 02, 2020 (GLOBE NEWSWIRE) -- Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the European Medicines...
Auris Medical Receives FDA and EMA Guidance for Keyzilen® Late-Stage Clinical Development Program
September 13, 2019 09:00 ET
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Auris Medical AG
Hamilton, Bermuda, Sept. 13, 2019 (GLOBE NEWSWIRE) -- Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical...
European Medicines Agency Grants PRIME Access to ProQR’s Sepofarsen for Leber’s Congenital Amaurosis 10
July 29, 2019 07:00 ET
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ProQR Therapeutics N.V.
Access based on positive interim analysis of clinical data as well as preclinical data to date PRIME designation provides a pathway for frequent and early interactions with the EMA aimed at...