European committee takes a second look at Alzheimer's drug and now says it should be approved
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
European watchdog partially approves new Alzheimer's drug
Europe's medicines watchdog on Thursday partially approved a marketing request for a long-awaited new treatment for Alzheimer ...
STAT2h
Changing course, European regulators now say Alzheimer’s treatment Leqembi should be approved
Reversing an earlier decision, European regulators recommended that an Alzheimer’s therapy from Eisai and Biogen should be ...
Yahoo Finance27d
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.com27d
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.
pharmaphorum4d
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 ...
precisionmedicineonline3h
EMA's CHMP Now Recommends Approval for Eisai, Biogen's Alzheimer's Drug Leqembi in Europe
The agency had previously recommended against marketing authorization for the Alzheimer's disease but reconsidered after a review.
FierceBiotech29d
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 ...
Reuters22d
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 ...
MercoPress9d
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 Technology22d
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 ...
gh.bmj25d
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 ...