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 ...

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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), ...

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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 ...

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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 ...

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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) ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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. ...

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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, ...

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