A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...

Europe's medicines watchdog on Thursday partially approved a marketing request for a long-awaited new treatment for Alzheimer ...

(RTTNews) - Janssen-Cilag International NV, a Johnson & Johnson company (JNJ), Monday said that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended ...

The European Union health agency on Monday warned that Europe was set to miss goals on reducing the use of antibiotics, ...

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and (Nasdaq: BIIB, Corporate headquarters: Cambridge, ...

The European Medicines Agency said Thursday that its committee evaluating medical products has recommended partial approval ...

A European Medicines Agency committee had said in July that the medicine, called Leqembi, should be rejected, citing the modest benefits seen in trials and the potentially dangerous side effects ...

CuraTeQ Biologics' EMA GMP certification marks a key milestone in Aurobindo Pharma's expansion into biosimilars, with three ...

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 Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced a positive opinion has been received from the Committee for Medicinal ...

Shares in European vaccine makers tumbled after President-elect Donald Trump picked vaccine sceptic Robert F. Kennedy Jr. to ...

If approved by the EC, Tagrisso will be the first targeted therapy for European patients with unresectable EGFR-mutated cancer.