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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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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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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Monkeypox: EMA starts review for Imvanex

28 June 2022 - The EMA’s CHMP has started a review of data to extend the use of the smallpox ...

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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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Curium announces the submission of its marketing authorisation application for [18F]-DCFPyL to the EMA

27 June 2022 - Submission follows the completion of Phase III PYTHON clinical trial of [18F]-DCFPyL for recurrent prostate cancer in ...

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Trastuzumab deruxtecan supplemental new drug application submitted in Japan for patients with HER2 low metastatic breast cancer

27 June 2022 - Submission based on DESTINY-Breast04 results that showed trastuzumab deruxtecan demonstrated superior progression-free survival and overall survival ...

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Emergent BioSolutions announces FDA acceptance of biologics license application for AV7909 anthrax vaccine candidate

24 June 2022 - Emergent BioSolutions announced today that the U.S. FDA accepted for review the biologics license application for AV7909 ...

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Astellas submits fezolinetant new drug application to U.S. FDA

24 June 2022 - Application targets treatment of moderate to severe vasomotor symptoms associated with menopause ...

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Menarini Group and Radius Health submit new drug application to the U.S. FDA for elacestrant

22 June 2022 - Priority review requested; if accepted, anticipate an 8 month FDA review. ...

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Krystal Biotech submits biologics license application to U.S. FDA seeking approval of B-VEC for the treatment of patients with dystrophic epidermolysis bullosa

22 June 2022 - Krystal Biotech announced today the submission of a biologics license application to the U.S. FDA seeking ...

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Ikena Oncology receives FDA fast track designation for novel TEAD inhibitor IK-930 to treat unresectable NF2 deficient mesothelioma

22 June 2022 - Ikena Oncology today announced that the U.S. FDA has granted fast track designation for IK-930, the Company’s ...

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Trastuzumab deruxtecan type II variation application validated by EMA for patients with HER2 low metastatic breast cancer with HR positive and HR negative disease

22 June 2022 - Application based on DESTINY-Breast04 results that showed Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan demonstrated superior progression-free and ...

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