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 ...
AbbVie received a Complete Response Letter (CRL) from the FDA for its Biologics License Application (BLA) for ...
With a backdrop of mounting industry disruption and transition, Pharm Exec’s latest listing of the top global biopharma sales producers, its 25th, points to the importance of organizations doubling ...
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 ...
FDA is formalizing RWD as core evidence, enabling “single pivotal trial plus confirmatory evidence” approaches that may ...
Eligibility now includes ages 1–7 years with stage 2 T1D, defined by multiple diabetes autoantibodies plus dysglycemia ...
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 ...
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