Tag: CHMP
Bristol Myers: positive CHMP opinion for Reblozyl
(CercleFinance.com) – Bristol Myers Squibb has received a positive CHMP opinion for Reblozyl (luspatercept) in adult patients with anemia-associated non-transfusion-dependent beta-thalassemia (ATN). The recommendation will now be considered by the…
Sanofi: CHMP recommends EU approval of Dupixent for treatment of eosinophilic esophagitis
By Jean-Noel Legalland Published on 12/16/2022 at 1:48 p.m. Photo credit © Sanofi Corporate …
Moderna: CHMP recommends the use of a vaccine
(CercleFinance.com) – The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends the use of Moderna’s bivalent Spikevax Original/Omicron Covid-19 targeted BA.1 booster vaccine…
Sanofi: positive opinion from the CHMP in esophagitis – 12/16/2022 at 1:43 p.m.
(CercleFinance.com) – Sanofi announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of its Dupixent in the EU for the…
Roche: Positive opinion from the CHMP for the anti-influenza drug Xofluza
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Bayer: positive CHMP opinion on Eylea
(CercleFinance.com) – Bayer announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for an extension of indication…
Pfizer: CHMP recommends Comirnaty in pediatric recall
(CercleFinance.com) – The Committee for Medicinal Products for Human Use (CHMP) on Thursday recommended Pfizer and BionTech’s Covid-19 vaccine as a booster for coronavirus immunization in children aged five to…
ADC Therapeutics and Sobi Announce ZYNLONTA® (loncastuximab tesirine) Receives Positive CHMP Opinion in Europe for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
ADC Therapeutics SA (NYSE: ADCT) and Swedish Orphan Biovitrum AB (Sobi®) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted…
AstraZeneca: CHMP recommends several drugs
(CercleFinance.com) – AstraZeneca announced on Monday that the Committee for Medicinal Products for Human Use (CHMP), an offshoot of the European Medicines Agency, had recommended the marketing of several of…
Roche: Favorable CHMP opinion for Vabysmo
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AstraZeneca: a new positive opinion from the CHMP for Lynparza
(CercleFinance.com) – The European Medicines Agency announced on Friday that its Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion on a new indication for Lynparza,…
Eli Lilly: CHMP recommends migraine medication Rayvow
(CercleFinance.com) – Eli Lilly shares rose more than 3% on Wall Street on Friday after the European CHMP’s favorable recommendation for Rayvow, its migraine medication. The title is currently gaining…