AbbVie received a Complete Response Letter (CRL) from the FDA for its Biologics License Application (BLA) for ...
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 ...
This episode of The Ron Lanton Report explores how geography, policy, and capital are converging to redefine where innovation ...
Cell and gene therapies (CGT) continue to advance in the pharmaceutical industry. Despite continued investment in R&D, the ...
EVERSANA’s president discusses the evolving role of the Asembia conference, emerging commercialization trends, and what’s top of mind for pharma leaders this year.
In today’s Pharmaceutical Executive Daily, the FDA expands the use of Tzield to young children to delay the onset of stage 3 ...
A U.S. center of excellence for small-volume parenteral manufacturing is planned to supply sterile injectables domestically ...
FDA Expands Approval for Dupixent for Young Children with Uncontrolled Chronic Spontaneous Urticaria
Pediatric approval leveraged CupidKids pharmacokinetic bridging and safety assessments, with adverse events consistent across ...
Cell and gene therapies (CGT) continue to advance in the pharmaceutical industry. Despite continued investment in R&D, the ...
Eligibility now includes ages 1–7 years with stage 2 T1D, defined by multiple diabetes autoantibodies plus dysglycemia ...
Each April, thousands of leaders across the pharmaceutical and life sciences industry converge in Las Vegas for the Asembia ...
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