President Donald Trump is planning to fire FDA Commissioner Marty Makary, the Wall Street Journal reported on Friday. The plans haven’t been finalized and could

Daiichi Sankyo is scrapping plans to build antibody-drug conjugate manufacturing capacity and recorded an “extraordinary loss” of 149.4 billion Japanese yen ($950 million) after overpromising

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

Capricor has filed a lawsuit seeking to split from its commercial partner for Duchenne muscular dystrophy therapy, deramiocel, in the US.

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.