Yahoo Finance26d
European Medicines Agency's Panel Supports Approval Of Novartis' Kisqali In Patients With Early-Breast Cancer
On Friday, Novartis AG (NYSE:NVS) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Kisqali (ribociclib).
Benzinga.com26d
European Medicines Agency's Panel Supports Approval Of Novartis' Kisqali In Patients With Early-Breast Cancer
The CHMP recommended approval granting marketing authorization ... with generally low-grade symptomatic adverse events. The European Commission (EC) will decide in approximately two months.
European Medicines Agency Confirms Acceptance of Marketing Authorization Application for AVT05, a Proposed Biosimilar to Simponi® (golimumab)
About AVT23 AVT23 is a monoclonal antibody and proposed biosimilar to Xolair ® (omalizumab). AVT23 is an investigational compound and has not received regulatory approval in any country. Biosimilarity ...
pharmaphorum3d
When measuring European regulatory approval, the timestamp matters
specifically in comparing approval regulatory cycles for the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Last year we wrote a three-part series, "Life in the Fast ...
Anavex Life Sciences: Weighing The Pros And Cons Of A Possible EU Approval Scenario
Anavex Life Sciences' (AVXL) stock surged on new Alzheimer's trial data, but data's inconsistency raises concerns, making the ...
FierceBiotech28d
FDA puts Novavax's phase 3 plan for pair of vaccine programs on hold over nerve disease case
Ahead of this, the biotech had already offloaded half of the commercialization duties for its European Medicines Agency-approved COVID-19 subunit vaccine Nuvaxovid to Sanofi in exchange for $500 ...
Reuters21d
UK approves Lilly's Alzheimer's drug, but deemed 'too expensive' for wide use
signalling that patients are unlikely to get access following approval by the country's medicines regulator. While Lilly did not provide details on pricing in the UK, the drug costs about $32,000 ...
MercoPress8d
Japanese vaccine against dengue approved for use in Argentina
According to a statement from the Argentine Health Ministry, the National Administration of Medicines ... The regulatory agency approved the drug for people aged 4 and over, regardless of whether ...
Pharmaceutical Technology21d
J&J’s Darzalex combination gains expanded label for multiple myeloma in Europe
The label expansion for the anti-CD38 antibody was supported by data from the ongoing Phase III PERSEUS trial that was submitted to to the European Medicines Agency in March 2024. Darzalex initially ...
precisionmedicineonline15d
Novartis Sees Steady Q3 Pluvicto Sales Growth as it Readies to Triple Eligible Population in 2025
Scemblix (asciminib), a STAMP inhibitor that Novartis ... to succeed in the long run." The European Medicines Agency's ...
gh.bmj24d
The WHO Global Benchmarking Tool: a game changer for strengthening national regulatory capacity
This process can be slow, burdensome and ineffective in poorly functioning NRAs and often becomes a superficial ‘rubber stamp’ or a barrier to ... Mexico and the USA), European Medicines Agency and ...