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CHMP

Showing 15 posts of 110 posts found.

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CHMP issue positive opinion for Incyte and MorphoSys’ tafasitamab

June 29, 2021
Manufacturing and Production CHMP, EMA, EU, FDA, US

Incyte and MorphoSys have announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive …

News

Self-administered Crysvita receives positive CHMP opinion

May 10, 2021
Sales and Marketing CHMP, EMA

Kyowa Kirin’s drug for a rare metabolic bone disease, Crysvita, has received a positive opinion from the EMA’s Committee for …

News
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LEO Pharma receives positive CHMP opinion for dermatitis treatment

April 26, 2021
Sales and Marketing CHMP, EMA, EU, dermatitis

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion …

News

Janssen’s multiple sclerosis treatment recommended by EMA

March 29, 2021
Sales and Marketing CHMP, EMA, Janssen, Johnson & Johnson, PONVORY, multiple sclerosis

Janssen’s PONVORY therapy for the treatment of adults with relapsing forms of multiple sclerosis (MS) has been recommended by the …

News
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Pfizer and Merck KGaA secure CHMP recommendation for Bavencio in Europe for first-line maintenance of urothelial carcinoma

December 14, 2020
Sales and Marketing Bavencio, CHMP, EMA, Merck, Pfizer, pharma, urothelial carcinoma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given its recommendation for …

News
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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 …

News
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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 …

News
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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 …

News
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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
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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 …

News
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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 …

News
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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), …

News
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Genmab’s Darzalex secures CHMP recommendation in Europe for front-line multiple myeloma

December 13, 2019
Medical Communications, Sales and Marketing CHMP, Genmab, darzalex, pharma

The Committee for Medicinal Products for Human Use (CHMP), an advisory panel for the European Medicines Agency, has given its …

News
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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 …

News

Bayer’s Vitravki poised to become first tumour-agnostic therapy in EU following CHMP recommendation

July 30, 2019
Manufacturing and Production, Sales and Marketing Bayer, CHMP, Cancer, EU, Vitrakvi, pharma

Bayer’s oral TRK inhibitor Vitrakvi (larotrectinib) could be set to become the European Union’s first drug approved in a tumour-agnostic …

News
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