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Aurinia Announces Positive CHMP Opinion for LUPKYNIS® (voclosporin) for the Treatment of Adults with Active Lupus Nephritis in Europe

July 22, 2022

Press release content from Business Wire. The AP news staff was not involved in its creation.

United States United Kingdom Peter Greenleaf Sue Evans Dana Lynch European Union

Source: apnews.com

Gilead Sciences, Inc.: CHMP Adopts Positive Opinion Recommending Veklury (Remdesivir) Receive Full Marketing Authorization for the Treatment of Patients With COVID-19

July 22, 2022

-- If Granted by the European Commission, Veklury will Become the Only Direct-Acting Antiviral with Full Marketing Authorization in the EU -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that

Foster City United States Jacquie Ross Nicole Rodriguez Merdad Parsey Gilead Sciences

Source: finanznachrichten.de

Investegate |Bavarian Nordic A/S Announcements | Bavarian Nordic A/S: Bavarian Nordic Receives Positive CHMP Opinion on the Extension of Vaccine Label to Include Monkeypox

July 22, 2022

Investegate announcements from Bavarian Nordic A/S, Bavarian Nordic Receives Positive CHMP Opinion on the Extension of Vaccine Label to Include Monkeypox

United States Paul Chaplin Graham Morrell European Commission European Health Emergency Preparedness Janssen Pharmaceutical Companies Of Johnson

Source: investegate.co.uk

Bavarian Nordic Imvanex vaccine gets EMA panel backing for use in monkeypox

July 22, 2022

A committee of the European Medicines Agency (EMA) recommended the expanded approval of Bavarian Nordic's (BVNKF) (BVNRY) smallpox vaccine Imvanex for use in preventing.The...

Paul Chaplin Tonix Pharmaceuticals Emergency Task European Medicines Agency European Commission European Health Emergency Preparedness

Source: seekingalpha.com

KITE'S CAR T-CELL THERAPY TECARTUS® (BREXUCABTAGENE AUTOLEUCEL) RECEIVES POSITIVE CHMP OPINION IN RELAPSED OR REFRACTORY ACUTE LYMPHOBLASTIC LEUKAEMIA (r/r ALL)

July 22, 2022

KITE&rsquo;S&nbsp; CAR&nbsp; T-CELL&nbsp; THERAPY&nbsp; TECARTUS&reg;&nbsp; (BREXUCABTAGENE&nbsp; AUTOLEUCEL)&nbsp; RECEIVES&nbsp; POSITIVE&nbsp; CHMP&nbsp; OPINION&nbsp; IN&nbsp; RELAPSED&nbsp; OR&nbsp; REFRACTORY&nbsp; ACUTE&nbsp; LYMPHOBLASTIC&nbsp; LEUKAEMIA&nbsp; (r/r ALL)&nbsp;&ndash;&nbsp; Tecartus&reg; (Brex...

United States Santa Monica United Kingdom Foster City Christi Shaw Brexucabtagene Autoleucel

Source: pharmiweb.com

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Janssen Receives Positive CHMP Opinion for Novel Bispecific Antibody TECVAYLI (teclistamab) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma (RRMM)

July 22, 2022

Teclistamab is the first T-cell redirecting bispecific antibody to receive a positive CHMP opinion for adults with RRMM and highlights Janssen's commitment to innovation in multiple myeloma The

United States Jenni Mildon Edmond Chan Mbch Peter Lebowitz None Of The Janssen Pharmaceutical Companies American Society Of Clinical Oncology

Source: finanznachrichten.de

Aurinia Pharmaceuticals Inc.: Aurinia Announces Positive CHMP Opinion for LUPKYNIS (voclosporin) for the Treatment of Adults with Active Lupus Nephritis in Europe

July 22, 2022

Positive CHMP opinion is based on a comprehensive submission including data from the pivotal AURORA 1 efficacy study and the AURORA 2 continuation study, demonstrating voclosporin to be safe and well

United States United Kingdom Peter Greenleaf Sue Evans Dana Lynch Aurinia Pharmaceuticals Inc

Source: finanznachrichten.de

Investegate |F. Hoffmann-La Roche Ltd Announcements | F. Hoffmann-La Roche Ltd: CHMP recommends EU approval of Roche's Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss

July 22, 2022

Investegate announcements from F. Hoffmann-La Roche Ltd, CHMP recommends EU approval of Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss

United States United Kingdom Levi Garraway Loren Kalm Roche Vabysmo Nathalie Altermatt

Source: investegate.co.uk

DGAP-News: Moderna, Inc.: EMA Committee for Medicinal Products for Human Use (CHMP) Recommends Use of the Moderna COVID-19 Booster in Adolescents (12-17 Years) in the European Union

July 22, 2022

DGAP-News: Moderna, Inc. / Key word(s): Miscellaneous EMA Committee for Medicinal Products for Human Use (CHMP) Recommends Use of the Moderna COVID-19 Booster in Adolescents (12-17 Years)

United Kingdom Lavina Talukdar Luke Mircea Willats European Commission Distribution Services Exchange Commission

Source: finanznachrichten.de