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June 08, 2023
The complaint alleges that Medicaid price controls implemented in the Inflation Reduction Act will negatively impact biopharmaceutical innovation.
The document builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies.
June 05, 2023
Reimbursement for Alzheimer's medicines still will occur only with the completion of studies to support full FDA approval.
FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products.
June 02, 2023
The future is set to be a running theme for this year’s CPHI event, which will take place in-person at the Fira Barcelona Gran Via in Spain between 24–26 October 2023.
May 30, 2023
The guidance describes FDA’s current recommendations regarding adjusting for covariates in statistical analysis of randomized clinical trials.
The next Cannabis Science Conference Fall meeting is soliciting a call for abstracts.
May 26, 2023
Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change.
May 25, 2023
FDA has approved the first topical gene therapy product for treating wounds in patients with dystrophic epidermolysis bullosa.
FDA has approved AbbVie’s EPKINLY (epcoritamab-bysp), a bispecific antibody for treating relapsed or refractory diffuse large B-cell lymphoma.