US suitability petition submissions see an uptick against the backdrop of GDUFA III new goals for the FDA's response to such petitions. The Pink Sheet tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.

Sponsors return with US suitability petition submissions against the backdrop of GDUFA III new goals for the FDA's response to such petitions. Scrip tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.

US suitability petition submissions see an uptick against the backdrop of GDUFA III new goals for the FDA's response to such petitions. The Pink Sheet tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.

The damage at one of Pfizer’s largest injectables facilities could lead to gains for a few Indian companies, analysts feel. However, regulatory risks, litigation pay-outs and other challenges will slow growth for domestic firms and Indian units of multinationals like Abbott and Pfizer in FY24, says rating agency ICRA as Q1 results begin coming in