Lupin receives positive CHMP opinion for biosimilar Ranibizumab
Lupin has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has…
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Browsing Tag
CHMP
Dr. Reddy’s receives positive CHMP opinion from EMA for AVT03
Dr. Reddy’s Laboratories announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use…
Biocon Biologics’ Ustekinumab Biosimilar receives positive CHMP opinion
YESINTEK recommended for approval to treat psoriasis, psoriatic arthritis, and Crohn’s disease in adults and children
Biocon Biologics gets positive CHMP opinion for YESAFILI, biosimilar Aflibercept
YESAFILI is intended for the treatment of neovascular age-related macular degeneration, visual impairment due to macular oedema…
EMA recommends marketing authorisation for Scemblix by Novartis
While many patients will benefit from available TKI therapies, a significant proportion may experience intolerance or resistance…
EU regulator asks for more COVID vaccine data from Valneva
Valneva said the EMA Committee for Medicinal Products for Human Use (CHMP) had a fresh list of questions, including requests for…
CHMP recommends EU approval of Roche’s Polivy combination for people with previously untreated…
The recommendation is based on pivotal data from the phase-III Polarix study
France’s Valneva expects recommendation on COVID-19 vaccine by end-March
Valneva has received a list of questions on its VLA2001 vaccine from the Committee for Medicinal Products for Human Use (CHMP) and…
European Commission approves Actemra/RoActemra by Roche to treat severe COVID-19
Approval based on results from four phase-III studies in motre than 5,500 patients
CHMP recommends EU approval of Actemra/RoActemra to treat patients with severe COVID-19
Actemra/RoActemra reduced the risk of death in patients with severe COVID-19, as evidenced by a review of four phase-III studies.…