Update on FDA Priority Review of LEQEMBI® IQLIK™ (Lecanemab-Irmb) Subcutaneous Injection as a Starting Dose for Early Alzheimer's Disease

Eisai, Biogen face delay to subcutaneous Leqembi

Eisai and Biogen are facing a delay in the FDA review of injectable Leqembi for initial dosing in Alzheimer's, viewed as a key growth driver.

FDA to reevaluate spurned cell therapy; Under-the-skin Leqembi review extended

Pierre Fabre claims to now be “aligned” with U.S. regulators on the path forward for a twice-rejected treatment. Elsewhere, Argenx swapped CEOs and Blackstone made a $250 million biotech investment.

Biogen says FDA extends review of Leqembi alzheimer’s injection (BIIB:NASDAQ)

FDA extends review of Biogen & Eisai’s LEQEMBI IQLIK for early Alzheimer’s; new PDUFA date is Aug 24, 2026.

Update on FDA Priority Review of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection as a Starting Dose for Early Alzheimer's Disease

TOKYO and CAMBRIDGE, Mass., May 8, 2026

FDA delays Leqembi decision; Artiva raises $300M on RA data; Pharvaris prices offering

🗓️ FDA delays subcutaneous Leqembi decision: Originally slated for later this month, the decision date now falls on August 24, Biogen and Eisai said. The agency asked for more information from ...

FDA delays review of weekly Alzheimer’s shot Leqembi Iqlik

FDA sought extra information it deemed a major amendment, adding three months to review. BioArctic says no approvability concerns have been raised.