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EMA

Showing 15 posts of 400 posts found.

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EMA’s CHMP recommends conditional approval for Kite Pharma’s CAR T therapy for mantle cell lymphoma

October 20, 2020
Manufacturing and Production, Sales and Marketing CAR T, CAR-T, CHMP, EMA, kite pharma, lymphoma

Kite Pharma’s anti-CD19 chimeric antigen receptor (CAR) T cell therapy known as KTE-X19 has received positive recommendation from the EMA’s …

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Sanofi’s Dupixent chalks up CHMP recommendation for paediatric severe atopic dermatitis

October 19, 2020
Sales and Marketing Dupixent, EMA, Sanofi, atopic dermatitis

Sanofi’s interleukin-4 and -13 inhibitor Dupixent (dupilumab) has been given the recommendation of the European Medicines Agency’s Committee for Medicinal …

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CHMP recommendation for Janssen’s Tremfya in active psoriatic arthritis

October 19, 2020
Sales and Marketing CHMP, EMA, Janssen, Tremfya

Janssen’s interleukin (IL)-23 inhibitor Tremfya (guselkumab) has scored a recommendation from the EMA’s Committee for Medicinal Products for Human Use …

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EMA launches rolling regulatory review of Pfizer and BioNTech’s COVID-19 vaccine

October 7, 2020
Research and Development, Sales and Marketing BioNTech, COVID-19, EMA, Pfizer, Vaccine

European Medicines Agency has launched a “rolling review” of the promising COVID-19 vaccine candidate BNT162b2 currently in development from BioNTech …

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EMA expands label for UCB’s Cimzia in axial spondyloarthritis

August 5, 2020
Research and Development, Sales and Marketing Cimzia, EMA, Europe

The European Medicines Agency has expanded the existing approval of UCB’s Cimzia (certolizumab pegol) to cover the treatment of axial …

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Kyowa Kirin’s Crysvita secures CHMP support in rare X-linked hypophosphataemia

July 28, 2020
Manufacturing and Production, Sales and Marketing CHMP, EMA

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has given its backing to Kyowa Kirin’s …

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Two CHMP recommendations for AstraZeneca: Imfinzi in first-line lung cancer, Calquence in chronic lymphocytic leukaemia

July 27, 2020
Sales and Marketing AstraZeneca, CHMP, Calquence, EMA, Imfinzi

AstraZeneca has secured two new recommendations for approval of its products from the European Medicines Agency’s Committee for Medicinal Products …

News

EMA gives market authorisation application to epilepsy treatment from Arvelle Therapeutics

March 30, 2020
Sales and Marketing EMA, EMA approvals, approvals, epilepsy

The European Medicines Agency (EMA) has accepted a marketing authorisation application (MAA) for a cenobamate adjunctive treatment of focal-onset seizures …

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Ameluz approved by European Commission for treatment for actinic keratosis

March 11, 2020
Research and Development EC, EMA, Europe, Lesions

Biofrontera AG has announced the European Commission has approved the use of their drug Ameluz in combination with photodynamic therapy …

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Positive CHMP approval for Takeda’s Alunbrig in ALK+ advanced non-small lung cancer

March 4, 2020
Research and Development CHMP, EMA, Takeda, lung cancer, pharma

Takeda’s Alunbrig (brigatinib) has been recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human …

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Takeda’s subcutaneous vedolizumab nabs CHMP nod for maintenance of ulcerative colitis and Crohn’s

February 28, 2020
Medical Communications, Sales and Marketing CHMP, EMA, Takeda, vedolizumab

Takeda’s subcutaneous formulation of its gut-selective biologic vedolizumab has secured recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal …

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AbbVie’s Venclyxto pins down CHMP approval for treatment-naive chronic lymphocytic leukaemia

February 3, 2020
Sales and Marketing AbbVie, CHMP, EMA, Venclyxto, pharma

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has awarded recommendation to AbbVie’s Venclyxto (venetoclax), …

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Novartis’ Beovu scores CHMP recommendation after proving non-inferior to Eylea in wet age-related macular degeneration

December 13, 2019
Medical Communications, Sales and Marketing Beovu, EMA, Novartis, pharma

Novartis’ single-chain antibody fragment Beovu has secured recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use …

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Jazz Pharma sleep disorder drug secures CHMP backing for treatment of excessive daytime sleepiness in Europe

November 18, 2019
Research and Development, Sales and Marketing EMA, jazz pharma, narcolepsy, pharma, solriamfetol

Jazz Pharma’s solriamfetol has secured a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human …

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EMA’s CHMP recommends new dosing schedule for Opdivo in melanoma

September 25, 2019
Research and Development, Sales and Marketing BMS, Bristol-Myers Squibb, CHMP, EMA, melanoma, opdivo, pharma

Bristol-Myers Squibb has revealed that its blockbuster immunotherapy drug Opdivo (nivolumab) has secured recommendation from the EMA’s Committee for Medicinal …

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