FDA to speed reviews for drugs supporting ‘national interests’

A new pilot program announced by FDA Commissioner Martin Makary would award vouchers that could cut drug reviews to one or two months — but only for products that meet a special criteria.

FDA to miss approval deadline for Kalvista drug due to ‘resource constraints’

A “heavy workload” and “limited resources” have left the agency unable to meet a June 17 deadline to approve a therapy Kalvista has been developing for hereditary angioedema. 

Inside oncology’s research boom

Moderna wins FDA OK to widen use of RSV vaccine

The agency’s decision to clear Moderna’s shot for use in certain younger adults is a much-needed win for a company that’s been significantly impacted by the recent changes in FDA and HHS leadership.

Pharma’s wins and losses in the budget bill

Key pharma reforms are up in the air as Republicans battle over their mammoth legislation that includes significant healthcare spending cuts.

Could the FDA take an indirect approach to regulate lab developed tests?

Attorneys said many questions remain about test regulation after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.

FDA clears CSL’s swelling disease drug; Regeneron loses 23andMe auction

The agency cleared CSL’s hereditary angioedema drug days after “resource constraints” delayed a rival medicine. Elsewhere, Intellia revealed new data and Lilly beefed up an online service offering access to Zepbound.