FDA backs generics onshoring push with ANDA priority scheme
Drug manufacturers who test and produce their generic medicines on US soil will now have access to priority review.
06 October 2025
06 October 2025
Drug manufacturers who test and produce their generic medicines on US soil will now have access to priority review.
Rocket has pulled an approval application to the FDA, with the biotech considering offloading the asset via external partnerships.
Trogenix’s platform uses an AAV packed with two payloads in a “Trojan horse” approach to cancer treatment.
The combination is now the first and only approved dual maintenance therapy for ES-SCLC.
The approval is supported by data from the Phase IIb VISION-DMD trial.
Discovered at McMaster, the newly identified antibiotic presents a potential new therapy for individuals living with Crohn's disease.
The deal means Pfizer has committed to pricing current and any new medicines in all state Medicaid programs to the same prices in other developed countries.
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