Replimune to resubmit twice-rejected drug for approval after FDA shakeup

Replimune was among the drugmakers that had criticized the FDA for what they called inconsistent guidance around trials and approvals.

US FDA approves AbbVie's rare blood cancer drug

(Corrects to clarify the total number of patients in the study in paragraph 10) May 27 (Reuters) - The U.S. Food and Drug ...
GlobalData on MSN

FDA grants priority review for Sanofi’s venglustat NDA

The decision is anticipated by 25 November 2026.
Stocktwits on MSN

ABBV stock gains on winning FDA approval for rare blood cancer drug

The drug is specifically approved to treat blastic plasmacytoid dendritic cell neoplasm (an ultra-rare and aggressive type of ...
Fierce Biotech

FDA delays ruling on AstraZeneca’s breast cancer drug after negative adcomm vote

The FDA has delayed a decision on the approval of AstraZeneca’s camizestrant, deferring its ruling to review analyses filed ...
Fierce Pharma

Outlook moves toward potential US nod for thrice-snubbed eye drug with FDA appeal win

Outlook Therapeutics has notched a win in its uphill battle to commercialize an ophthalmic version of Roche’s Avastin ...

Replimune Gets Third Try at FDA Approval After Makary Departure

Experimental melanoma drug was rejected twice because the Food and Drug Administration questioned its study design.

FDA blocked melanoma drug as confusion reigned under Makary

The FDA’s recent decision to withhold approval of a new skin cancer treatment fell like a hammer on doctors who treat ...

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.

Director of FDA drug program removed

A Food and Drug Administration official involved in scrutinizing the safety of antidepressants, COVID-19 vaccines and other ...