CHMP
CHMP issue positive opinion for Incyte and MorphoSys’ tafasitamab
June 29, 2021Manufacturing 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 …
Self-administered Crysvita receives positive CHMP opinion
May 10, 2021Sales 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 …
LEO Pharma receives positive CHMP opinion for dermatitis treatment
April 26, 2021Sales 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 …
Janssen’s multiple sclerosis treatment recommended by EMA
March 29, 2021Sales 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 …
Pfizer and Merck KGaA secure CHMP recommendation for Bavencio in Europe for first-line maintenance of urothelial carcinoma
December 14, 2020Sales 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 …
EMA’s CHMP recommends conditional approval for Kite Pharma’s CAR T therapy for mantle cell lymphoma
October 20, 2020Manufacturing 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 …
CHMP recommendation for Janssen’s Tremfya in active psoriatic arthritis
October 19, 2020Sales 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 …
Kyowa Kirin’s Crysvita secures CHMP support in rare X-linked hypophosphataemia
July 28, 2020Manufacturing 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 …
Two CHMP recommendations for AstraZeneca: Imfinzi in first-line lung cancer, Calquence in chronic lymphocytic leukaemia
July 27, 2020Sales 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 …
Positive CHMP approval for Takeda’s Alunbrig in ALK+ advanced non-small lung cancer
March 4, 2020Research 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 …
Takeda’s subcutaneous vedolizumab nabs CHMP nod for maintenance of ulcerative colitis and Crohn’s
February 28, 2020Medical 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 …
AbbVie’s Venclyxto pins down CHMP approval for treatment-naive chronic lymphocytic leukaemia
February 3, 2020Sales 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), …
Genmab’s Darzalex secures CHMP recommendation in Europe for front-line multiple myeloma
December 13, 2019Medical 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 …
EMA’s CHMP recommends new dosing schedule for Opdivo in melanoma
September 25, 2019Research 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 …
Bayer’s Vitravki poised to become first tumour-agnostic therapy in EU following CHMP recommendation
July 30, 2019Manufacturing 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 …
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