In today’s ACT Brief, we examine how the FDA’s CNPV Program is reshaping operational planning and accelerated submission ...

FDA lowers surveillance requirement to 50 patients from 300 patients in original HDE approval based on assessment of first 21 SAVE Surveillance ...

Moderna recently faced pressure after the U.S. Food and Drug Administration announced plans to require more rigorous safety ...

Analysts at Guggenheim Partners expect Voyxact to see “broad commercial uptake” given its relatively broad label compared ...

In this Q&A, John Kirk, principal regulatory specialist at Veristat, explains how the FDA’s Commissioner’s National Priority ...

FDA moves reshaping drug policy include fast-track programs, updated biosimilar guidance, and new rare disease approval pathways.

Detailed price information for Arrowhead Pharma (ARWR-Q) from The Globe and Mail including charting and trades.

The FDA has cleared Neurosense to begin its pivotal Phase 3 clinical trial of PrimeC for the treatment of amyotrophic lateral ...

Arrowhead Pharmaceuticals Inc (ARWR) achieves a milestone with FDA approval of Redemplo and secures a lucrative partnership ...

Through the FDA’s priority voucher program, Novo Nordisk said Nov. 26 it has filed an application seeking approval of its Wegovy 7.2 milligram injection.  Wegovy (semaglutide) is currently approved in ...

Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for ...