FDA

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Pharma

Regulatory tracker: GSK wins pediatric nod for lupus autoinjector

Here, we're tracking the regulatory progress of in-market products, including expansions into key geographies and new indications.
FDA

FDA's acting CDER head heads for the exit: report

Jun 23, 2025 1:48pm
Clock in front of the subway
Favicon Fierce Biotech

FDA 'on track' to meet all PDUFA dates, Marty Makary says

Jun 18, 2025 4:00am
FDA

Swedish contract manufacturer hit with FDA warning letter

Jun 9, 2025 9:09am
Marty Makary FDA Commissioner

Four states ask FDA to lift restrictions on mifepristone

Jun 6, 2025 8:21am
Moderna

Moderna's next-gen COVID shot gets FDA backing

Jun 2, 2025 9:01am