Medscape9d
EMA to Review New Safety Data on Alzheimer’s Drug Leqembi
The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.
Yahoo Finance5d
CHMP Gives Nod to Expanded Use of J&J's Rybrevant & AZN's Imfinzi
Johnson & Johnson JNJ announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion for the expanded use of the ...
Yahoo Finance6d
MRK Gets Positive CHMP Nod for 21-Valent Pneumococcal Jab Capvaxive
Merck MRK announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of its 21-valent pneumococcal conjugate vaccine ...
Medscape10d
EMA Expedites Adolescent Chikungunya Vaccine Recommendation
In its first meeting of 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave the green light for the first vaccine in the EU to protect adolescents ...
Pharmabiz5d
EMA committee recommends extension of marketing authorisation for Janssen-Cilag’s subcutaneous Rybrevant to treat advanced EGFR-mutated NSCLC
Janssen-Cilag International NV, a Johnson & Johnson company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an ...
Yahoo Finance17d
X4 Pharmaceuticals Announces EMA Validation of Marketing Authorization Application (MAA) for Mavorixafor for the Treatment of WHIM Syndrome
has been validated for review and is now under evaluation with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The EMA previously granted orphan ...
JD Supra3d
EU Biosimilar Regulatory and Launch Updates
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted ...
ots17d
X4 Pharmaceuticals Announces EMA Validation of Marketing Authorization Application (MAA) for Mavorixafor - licenced to Norgine for commerc
has been validated for review and is now under evaluation with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). In April 2024, mavorixafor received U.S.
Mena FN17d
X4 Pharmaceuticals Announces EMA Validation Of Marketing Authorization Application (MAA) For Mavorixafor For The Treatment Of WHIM Syndrome
has been validated for review and is now under evaluation with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The EMA previously granted orphan ...