FDA

News

Medical vials and Syringe, Isolated on Blue background

Lilly to ship COVID-19 drug straight away after FDA green li...

Eli Lilly has said it will start shipping supplies of its COVID-19 drug bamlanivimab immediately, after claiming emergency-use authorisation (EUA) for the antibody.

News

FDA panel unimpressed with data for Alzheimer’s drug aducanu...

The FDA may have been minded to approve Biogen and Eisai’s Alzheimer’s candidate aducanumab, but its clinical advisors have little doubt that the evidence for the drug is lacking.<

News

Could an FDA inspection scupper CVR deadline for BMS’ liso-c...

Bristol-Myers Squibb posted a solid set of financial results for the third quarter, but shares slid on investor fears that a payout tied new product approvals was in jeopardy.

News

Trials and tribulations in Biogen's Alzheimer’s drug reviews

Regulatory reviews of Biogen’s Alzheimer’s drug aducanumab are now ongoing on both sides of the Atlantic, but debate is still ongoing about whether the data behind the drug is strong enough

News

FDA sets April verdict for Pfizer’s “underestimated” atopic ...

Pfizer could be just a few months away from getting FDA approval for its JAK1 inhibitor abrocitinib in atopic dermatitis, a drug that CEO Albert Bourla believes hasn’t been given the credit

News