BMY Gets Positive CHMP Opinion for Opdivo, Yervoy Combo and Breyanzi
The CHMP recommends approval of Bristol Myers' Opdivo plus Yervoy for the first-line treatment of hepatocellular carcinoma ...
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MRK Gets Positive CHMP Nod for 21-Valent Pneumococcal Jab Capvaxive
The Committee for Medicinal Products for Human Use recommends approval for Merck's pneumococcal 21-valent conjugate vaccine, ...
AstraZeneca’s Imfinzi recommended for approval in EU by CHMP
Imfinzi has been recommended for approval in the European Union, EU, as monotherapy for the treatment of adults with ...
Halozyme Says CHMP Recommends Approval Of Subcutaneous Rybrevant Developed With ENHANZE In NSCLC
Janssen-Cilag International NV, a Johnson & Johnson company, received European Medicines Agency's Committee for Medicinal Products ...
PMLiVE3d
BMS receives CHMP recommendation for Breyanzi in follicular lymphoma
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the CD19-directed CAR T cell therapy, which is already approved in the EU for certain lymphomas, be authorised to treat ...
ophthalmologytimes6d
CHMP of the European Medicines Agency issues positive opinion on 2 aflibercept biosimilars
The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...
PharmiWeb6d
CHMP recommends subcutaneous RYBREVANT® (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an ...
PMLiVE6d
J&J’s subcutaneous Rybrevant receives positive CHMP opinion for advanced lung cancer
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the subcutaneous (SC) formulation be approved ...
J&J gets positive EU opinion for subcutaneous Rybrevant
EU regulators have issued a positive opinion for the extension of the market authorization for subcutaneous formulation of ...
JD Supra2d
EU Biosimilar Regulatory and Launch Updates
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee ...
Pharmabiz5d
EMA committee recommends extension of marketing authorisation for Janssen-Cilag’s subcutaneous Rybrevant to treat advanced EGFR-mutated NSCLC
EMA committee recommends extension of marketing authorisation for Janssen-Cilag’s subcutaneous Rybrevant to treat advanced EGFR-mutated NSCLC: Beerse, Belgium Tuesday, February ...