The CHMP renders a positive opinion recommending approval for BIIB and Eisai's Leqembi for treating early Alzheimer's disease ...

Reversing an earlier decision, European regulators recommended that the Alzheimer’s therapy Leqembi should be approved ...

Why one trial participant's healthy birth after her CAR-T treatment for lupus is catching resesarchers' attention: ...

The agency's new guidelines require drugmakers to provide viewers with a clearer picture of medications' risks and side effects. Congress also is looking at giving the FDA authority to regulate drug ...

Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.

AstraZeneca and Amgen announced that a Phase 3 trial of Tezspire (tezepelumab) showed a statistically significant and ...

Biogen's newer products include Spinraza (SMA, with partner Ionis), Leqembi (Alzheimers, with partner Eisai), Skyclarys ...

Eisai Europe Ltd. and Biogen Inc. announced today that a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) ...

TOKYO, Nov 15, 2024 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Japan Ltd announced today that a TV commercial will be ...

Azurity Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved Danziten™, the first and only nilotinib with no mealtime restrictions indicated for adult patients ...

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

If the European Commission decides to grant sales of the medicine, it will be the first Alzheimer's medicine available in the ...