Capricor Therapeutics Granted Orphan Drug and ATMP Status for Deramiocel by European Medicines Agency
Recently, Capricor announced that it had initiated its rolling Biologics License Application (BLA) submission process with the U.S. FDA seeking full approval of deramiocel to treat all patients ...
STAT5d
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 ...
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 ...
Pharmabiz1d
European Union recommends approval of AstraZeneca’s Tagrisso for patients with unresectable EGFR-mutated lung cancer
European Union recommends approval of AstraZeneca’s Tagrisso for patients with unresectable EGFR-mutated lung cancer ...
ジャパンタイムズ5d
European agency switches to recommending new Alzheimer's drug
The European Medicines Agency said Thursday that its committee evaluating medical products has recommended partial approval ...
European regulators green light new Alzheimer's drug after first rejecting it
European regulators initially said in July that the drug's benefits did not outweigh its risks. View on euronews ...
NurExone Biologic Secures EMA Orphan Status for ExoPTEN in Spinal Cord Injury, Accelerating Pathway to European Markets
NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (Germany: J90) (" NurExone " or the " Company "), a biopharmaceutical company developing exosome-based regenerative therapies, is pleased to announce ...
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.
Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and (Nasdaq: BIIB, Corporate headquarters: Cambridge, ...
Soligenix Announces Formation of European Medical Advisory Board for Cutaneous T-Cell Lymphoma
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet ...