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RSS FeedPosted by Michael Wonder on 04 Mar 2021
EMA starts rolling review of the Sputnik V COVID-19 vaccine
4 March 2021 - EMA’s CHMP has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia’s ...
Posted by Michael Wonder on 03 Mar 2021
Strongbridge Biopharma announces submission of new drug application for Recorlev (levoketoconazole) for the treatment of endogenous Cushing’s syndrome to the U.S. FDA
2 March 2021 - Recorlev (levoketoconazole) new drug application is supported by previously reported positive and statistically significant results from the ...
Posted by Michael Wonder on 03 Mar 2021
On Target Laboratories announces U.S. FDA acceptance and priority review of new drug application for pafolacianine sodium injection for identification of ovarian cancer during surgery
3 March 2021 - On Target Laboratories today announced that the U.S. FDA has accepted its new drug application for priority ...
Posted by Michael Wonder on 03 Mar 2021
Oblato announces fast track designation of OKN-007 for diffuse intrinsic pontine glioma from the FDA
3 March 2021 - Oblato announces that the FDA granted fast track designation of OKN-007, the proprietary drug for diffuse intrinsic ...
Posted by Michael Wonder on 03 Mar 2021
Oyster Point Pharma announces FDA acceptance for filing new drug application for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease
2 March 2021 - Prescription Drug User Fee Act target action date is 17 October 2021. ...
Posted by Michael Wonder on 03 Mar 2021
KemPharm announces FDA approval of Azstarys (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), a new once daily treatment for ADHD
2 March 2021 - KemPharm today announced that the U.S. FDA has approved the new drug application for Azstarys (formerly referred ...
Posted by Michael Wonder on 03 Mar 2021
FDA grants de novo to ML-based, real-time indicator of patient deterioration
2 March 2021 - Fifth Eye's non-invasive tool is the first to provide continuous monitoring of haemodynamic status using a single ...
Posted by Michael Wonder on 03 Mar 2021
Health Canada approves Brukinsa (zanubrutinib) for the treatment of Waldenström’s macroglobulinaemia
2 March 2021 - Approval is based on the Phase 3 ASPEN trial of Brukinsa compared to ibrutinib. ...
Posted by Michael Wonder on 03 Mar 2021
Relivion wearable brain neuromodulation technology cleared by FDA for the treatment of migraine
2 March 2021 - Relivion is the only non-invasive multi-channel neuromodulation technology for the treatment of acute migraine. ...
Posted by Michael Wonder on 02 Mar 2021
Cook Medical receives FDA breakthrough device designation for Zenith fenestrated+ endovascular graft
1 March 2021 - Cook Medical’s Zenith fenestrated+ endovascular graft product has received breakthrough device designation from the US FDA. ...
Posted by Michael Wonder on 02 Mar 2021
Drug industry pushes FDA to solve growing inspection backlog
2 March 2021 - Inspections are a vital tool to ensure the safety of new drugs as well as medicines already ...
Posted by Michael Wonder on 02 Mar 2021
Anuncia receives FDA breakthrough device designation for ReFlow System Mini
2 March 2021 - Anuncia received U.S. FDA breakthrough device designation for its ReFlow System Mini intended for the treatment of ...
Posted by Michael Wonder on 02 Mar 2021
Eyenovia announces FDA acceptance of the MydCombi new drug application
2 March 2021 - Eyenovia today announced that the U.S. FDA has accepted the Company’s new drug application for MydCombi, ...
Posted by Michael Wonder on 02 Mar 2021
Merck provides update on Keytruda (pembrolizumab) indication in metastatic small cell lung cancer in the US
1 March 2021 - Merck today announced the company is voluntarily withdrawing the US indication for Keytruda (pembrolizumab) for the treatment ...
Posted by Michael Wonder on 02 Mar 2021
EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine
2 March 2021 - Openness and transparency are key to building confidence in COVID-19 vaccines. Today, EMA and Health Canada ...