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February 07, 2023
Clinicians, pediatric patients, regulators, and more are being considered to further strengthen focus on unmet medical needs.
February 02, 2023
A Congressional probe of FDA’s approval of Alzheimer’s treatment targets the agency’s interactions with drug manufacturers.
January 23, 2023
In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.
January 16, 2023
The guidance provides examples of required and recommended information in the Dosage and Administration section.
January 02, 2023
Does the new regulatory framework have the potential to incentivise R&D investment in rare diseases?
December 21, 2022
Bylvay has minimal systemic exposure and acts locally in the small intestine as a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi).
December 03, 2022
Overall industry growth conceals growing numbers of smaller, faster-paced, adaptable corporate structures.
November 02, 2022
FDA keeps its user fees but fails to gain important reforms.
New medications show exciting outcomes for weight loss.
October 26, 2022
AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.