1 July 2022 - Hyloris Pharmaceuticals announces that it has today received a complete response letter from the US FDA on ...
30 June 2022 - Aura Biosciences today announced that the U.S. FDA has granted fast track designation for belzupacap sarotalocan (AU-011), ...
30 June 2022 - Final results from EPIC-HR study showed an 86% reduction in relative risk of hospitalisations or death from ...
29.June 2022 - Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit ...
29 June 2022 - This guidance (Guidance 3) is the third in a series of four methodological patient-focused drug development (PFDD) ...
22 June 2022 - Regulatory agencies have sought to speed up the review of new cancer medicines and reduce delays in ...
29 June 2022 - Novel GPRC5DxCD3 bispecific antibody receives breakthrough therapy designation based upon results from the Phase 1/2 MonumenTAL-1 study. ...
29 June 2022 - If approved, extended regimen would provide a longer treatment interval and additional dosing flexibility, alongside approved ...
29 June 2022 - Ipsen today announced that the U.S. FDA has accepted for priority review its resubmitted new drug ...
28 June 2022 - Additional Phase 2b data evaluating AD109 as potential treatment for obstructive sleep apnoea anticipated in Q3 ...
27 June 2022 - NDA Resubmission Addresses Issues Related to Vial Compatibility. ...
27 June 2022 - The U.S. FD has approved a supplemental indication for Qsymia (phentermine and topiramate extended-release capsules) for chronic ...
27 June 2022 - The U.S. FDA declined to approve Spero Therapeutics' oral antibiotic drug for the treatment of patients ...
27 June 2022 - Proposed rule is intended to increase options for the development of safe and effective non-prescription drugs. ...
27 June 2022 - The Biden administration wants to reach a narrow sectoral trade agreement with the Swiss pharmaceutical industry, ...