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 ...
DPA International on MSN1d
EU regulator reverses decision to block Alzheimer's drug lecanemab
The European Union's drugs regulator reversed its decision to block the Alzheimer's drug lecanemab, a treatment aimed at ...
Hosted on MSN1d
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 ...
FiercePharma16h
EU regulators endorse meds from BMS, J&J, Eisai and more—plus a clutch of biosims
Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.
InflaRx Gets EMA Nod for COVID-19 Treatment
InflaRx (IFRX) has released an update. InflaRx has received a positive opinion from the European Medicines Agency’s CHMP for GOHIBIC, a ...
Bristol Myers gets positive EMA opinion for repotrectinib
Bristol Myers Squibb (BMY) has received a recommendation for approval from an expert panel of the European Medicines Agency ...
Nippon1d
European Agency Switches to Recommending New Alzheimer's Drug
If the European Commission decides to grant sales of the medicine, it will be the first Alzheimer's medicine available in the ...
STAT1d
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 ...
Eisai receives positive CHMP opinion for Lecanemab in early Alzheimer’s disease
Eisai (ESAIY) and Biogen (BIIB) announced that a positive opinion has been received from the Committee for Medicinal Products for Human Use of ...
ndtvprofit3d
Aurobindo Pharma Subsidiary Receives GMP From European Medicines Agency For Biosimilars Facility
CuraTeQ Biologics' EMA GMP certification marks a key milestone in Aurobindo Pharma's expansion into biosimilars, with three ...
EU approves life changing 'important' Alzheimer's drug which can drastically slow onset
Lecanemab is the first treatment for Alzheimer’s disease licensed for use in Great Britain that shows some evidence of ...
BioPharma Dive1d
Eisai wins over European regulators on Alzheimer’s drug Leqembi
A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.