Blog
RSS FeedPosted by Michael Wonder on 01 Jul 2022
US FDA seeks more information on Maxigesic IV application
1 July 2022 - Hyloris Pharmaceuticals announces that it has today received a complete response letter from the US FDA on ...
Posted by Michael Wonder on 30 Jun 2022
Aura Biosciences receives FDA fast track designation for belzupacap sarotalocan (AU-011) for the treatment of non-muscle invasive bladder cancer
30 June 2022 - Aura Biosciences today announced that the U.S. FDA has granted fast track designation for belzupacap sarotalocan (AU-011), ...
Posted by Michael Wonder on 30 Jun 2022
Pfizer announces submission of new drug application to the U.S. FDA for Paxlovid
30 June 2022 - Final results from EPIC-HR study showed an 86% reduction in relative risk of hospitalisations or death from ...
Posted by Michael Wonder on 30 Jun 2022
From FDA to MHRA: are drug regulators for hire?
29.June 2022 - Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit ...
Posted by Michael Wonder on 29 Jun 2022
Patient focused drug development: selecting, developing, or modifying fit for purpose clinical outcome assessments
29 June 2022 - This guidance (Guidance 3) is the third in a series of four methodological patient-focused drug development (PFDD) ...
Posted by Michael Wonder on 29 Jun 2022
Clinical benefit and expedited approval of cancer drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia
22 June 2022 - Regulatory agencies have sought to speed up the review of new cancer medicines and reduce delays in ...
Posted by Michael Wonder on 29 Jun 2022
Janssen announces U.S. FDA breakthrough therapy designation granted for talquetamab for the treatment of relapsed or refractory multiple myeloma
29 June 2022 - Novel GPRC5DxCD3 bispecific antibody receives breakthrough therapy designation based upon results from the Phase 1/2 MonumenTAL-1 study. ...
Posted by Michael Wonder on 29 Jun 2022
Eylea (aflibercept) injection sBLA for every 16 week dosing regimen in patients with diabetic retinopathy accepted for FDA review
29 June 2022 - If approved, extended regimen would provide a longer treatment interval and additional dosing flexibility, alongside approved ...
Posted by Michael Wonder on 29 Jun 2022
Ipsen announces U.S. FDA priority review for palovarotene new drug application in patients with fibrodysplasia ossificans progressiva following resubmission
29 June 2022 - Ipsen today announced that the U.S. FDA has accepted for priority review its resubmitted new drug ...
Posted by Michael Wonder on 28 Jun 2022
Apnimed granted FDA fast track designation for AD109, a novel first in class oral pharmacologic combination for the treatment of obstructive sleep apnoea
28 June 2022 - Additional Phase 2b data evaluating AD109 as potential treatment for obstructive sleep apnoea anticipated in Q3 ...
Posted by Michael Wonder on 28 Jun 2022
Gilead resubmits new drug application to U.S. FDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor
27 June 2022 - NDA Resubmission Addresses Issues Related to Vial Compatibility. ...
Posted by Michael Wonder on 27 Jun 2022
FDA approves treatment for chronic weight management in certain paediatric patients aged 12 years and older
27 June 2022 - The U.S. FD has approved a supplemental indication for Qsymia (phentermine and topiramate extended-release capsules) for chronic ...
Posted by Michael Wonder on 27 Jun 2022
U.S. FDA declines to approve Spero's urinary tract infection drug
27 June 2022 - The U.S. FDA declined to approve Spero Therapeutics' oral antibiotic drug for the treatment of patients ...
Posted by Michael Wonder on 27 Jun 2022
FDA introduces innovative proposal to advance consumer access to non-prescription drugs
27 June 2022 - Proposed rule is intended to increase options for the development of safe and effective non-prescription drugs. ...
Posted by Michael Wonder on 26 Jun 2022
US seeks pharmaceutical deal with Switzerland to fast-track FDA approvals
27 June 2022 - The Biden administration wants to reach a narrow sectoral trade agreement with the Swiss pharmaceutical industry, ...