AbbVie received a Complete Response Letter (CRL) from the FDA for its Biologics License Application (BLA) for ...

The FDA has granted Compass Pathways with a rolling review for a New Drug Application (NDA) for its investigational ...

In today’s Pharmaceutical Executive Daily, the FDA issues a complete response letter to AbbVie for a biologics license ...

Regeneron reached an agreement with the U.S. government to link current and future drug prices to those in other developed ...

FDA is formalizing RWD as core evidence, enabling “single pivotal trial plus confirmatory evidence” approaches that may ...

Cell and gene therapies (CGT) continue to advance in the pharmaceutical industry. Despite continued investment in R&D, the ...

This episode of The Ron Lanton Report explores how geography, policy, and capital are converging to redefine where innovation ...

Eligibility now includes ages 1–7 years with stage 2 T1D, defined by multiple diabetes autoantibodies plus dysglycemia ...

Pediatric approval leveraged CupidKids pharmacokinetic bridging and safety assessments, with adverse events consistent across ...

The deal secures Lilly an in vivo gene therapy platform that could make CAR-T cell therapies accessible to a far broader ...

A U.S. center of excellence for small-volume parenteral manufacturing is planned to supply sterile injectables domestically ...

Cell and gene therapies (CGT) continue to advance in the pharmaceutical industry. Despite continued investment in R&D, the ...