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RSS FeedPosted by Michael Wonder on 28 Apr 2021
FDA begins review of GC Pharma’s blood product for marketing authorisation
27 April 2021 - The U.S. FDA has entered a full review of GC Pharma’s intravenous immunoglobulin therapy GC5107 for ...
Posted by Michael Wonder on 28 Apr 2021
Takeda announces U.S. FDA grants priority review for new drug application for mobocertinib (TAK-788) as a treatment for EGFR exon 20 insertion positive metastatic non-small cell lung cancer
28 April 2021 - Prescription Drug User Fee Act target action date set for 26 October 2021. ...
Posted by Michael Wonder on 27 Apr 2021
Medtronic receives FDA breakthrough designation for the Emprint ablation catheter kit
27 April 2021 - Minimally invasive option has potential to provide long-term management of lung malignancies while protecting lung function. ...
Posted by Michael Wonder on 27 Apr 2021
Sol-Gel Technologies provides update on FDA review of Epsolay
27 April 2021 - Sol-Gel Technologies today announced an update regarding the U.S. FDA approval process for Epsolay (benzoyl peroxide) ...
Posted by Michael Wonder on 27 Apr 2021
Enzyvant resubmits biologics licence application to FDA for RVT-802 for paediatric congenital athymia
27 April 2021 - Enzyvant today announced the resubmission of the biologics licence application to the U.S. FDA for RVT-802, ...
Posted by Michael Wonder on 27 Apr 2021
Fractyl announces FDA breakthrough device designation for Revita DMR in insulin treated type 2 diabetes
27 April 2021 - REVITA-T2Di trial is underway to evaluate the effectiveness of Revita DMR in improving glucose control while reducing ...
Posted by Michael Wonder on 27 Apr 2021
FDA guidance says sponsors should provide 'convincing' proof of concept data to support INDs for individualised medicine
26 April 2021 - Recent draft guidance from the US FDA addresses the non-clinical safety data to support investigational new ...
Posted by Michael Wonder on 27 Apr 2021
Reata announces FDA accepted for filing the NDA for bardoxolone for the treatment of patients with chronic kidney disease caused by Alport syndrome
26 April 2021 - Application assigned a PDUFA date of 25 February 2022. ...
Posted by Michael Wonder on 26 Apr 2021
Axsome Therapeutics announces FDA acceptance and priority review of new drug application for AXS-05 for treatment of major depressive disorder
26 April 2021 - FDA grants priority review and sets PDUFA action goal date of 22 August 2021. ...
Posted by Michael Wonder on 26 Apr 2021
FDA to scrutinise unproven cancer drugs after 10 year gap
26 April 2021 - U.S. regulators are convening a meeting to consider clawing back approvals from several cancer drugs that have ...
Posted by Michael Wonder on 24 Apr 2021
FDA and CDC lift recommended pause on Johnson & Johnson (Janssen) COVID-19 vaccine use following thorough safety review
23 April 2021 - Agencies underscore confidence in vaccine’s safety and effectiveness following data assessment; available data suggest potential blood clots ...
Posted by Michael Wonder on 23 Apr 2021
FDA authorises marketing of device to facilitate muscle rehabilitation in stroke patients
23 April 2021 - Today, the U.S. FDA authorised marketing of a new device indicated for use in patients 18 and ...
Posted by Michael Wonder on 23 Apr 2021
FDA grants accelerated approval to loncastuximab tesirine-lpyl for large B-cell lymphoma
23 April 2021 - Today the FDA granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics), a CD19-directed antibody and alkylating ...
Posted by Michael Wonder on 23 Apr 2021
Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy
23 April 2021 - VENTANA MMR RxDx Panel is the first immunohistochemistry predictive test in endometrial cancer for treatment with the ...
Posted by Michael Wonder on 22 Apr 2021
FDA approves immunotherapy for endometrial cancer with specific biomarker
22 April 2021 - Today, the U.S. FDA granted accelerated approval to Jemperli (dostarlimab) for treating patients with recurrent or advanced ...