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RSS FeedPosted by Michael Wonder on 19 Jan 2021
Global regulators highlight key role of health care professionals in fostering confidence in COVID-19 vaccines
19 January 2021 - EMA has endorsed a joint statement published today by the International Coalition of Medicines Regulatory Authorities ...
Posted by Michael Wonder on 19 Jan 2021
Occlutech's atrial flow regulator receives U.S. FDA breakthrough device designation for heart failure
19 January 2021 - Occlutech announced today that the U.S FDA has granted the Company a breakthrough revice designation for its ...
Posted by Michael Wonder on 19 Jan 2021
Metacrine announces FDA fast track designation for MET642 as a treatment of NASH
19 January 2021 - Metacrine today announced that the U.S. FDA has granted fast track designation to MET642, the company’s second ...
Posted by Michael Wonder on 19 Jan 2021
The European Medicines Agency's EU conditional marketing authorisations for COVID-19 vaccines
13 January 2021 - Few medicines are awaited as eagerly as COVID-19 vaccines. ...
Posted by Michael Wonder on 19 Jan 2021
Tessa Therapeutics receives PRIME designation from European Medicines Agency for CD30 CAR-T therapy
18 January 2021 - Tessa Therapeutics today announced that the EMA has granted PRiority MEdicines (PRIME) designation to the company's lead ...
Posted by Michael Wonder on 18 Jan 2021
Norway finds no direct link between elderly deaths and vaccine
19 January 2021 - Health authorities in Norway say there's no evidence of a direct link between the recent string ...
Posted by Michael Wonder on 18 Jan 2021
FDA sped progress for most of 2020's novel drugs
14 January 2021 - Most novel drugs approved by the US FDA in 2020 made their way through the approvals process ...
Posted by Michael Wonder on 18 Jan 2021
Norwegian investigation of COVID-19 vaccination risks for elderly, very frail patients
17 January 2021 - In recent days the TGA has received reports of about 30 deaths in over 40,000 elderly individuals ...
Posted by Michael Wonder on 16 Jan 2021
FDA grants accelerated approval to Darzalex Faspro for newly diagnosed light chain amyloidosis
15 January 2021 - Today, the FDA granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech) in combination ...
Posted by Michael Wonder on 16 Jan 2021
FDA approves fam-trastuzumab deruxtecan-nxki for HER2 positive gastric adenocarcinomas
15 January 2021 - Today, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or ...
Posted by Michael Wonder on 15 Jan 2021
FDA grants fast track designation to padeliporfin ImPACT for Steba biotech
15 January 2021 - Ambitious development program for multiple solid tumours with high unmet need, starting with low grade upper tract ...
Posted by Michael Wonder on 15 Jan 2021
Regulation of software based medical devices
15 January 2021 - The TGA has updated its guidance on the regulation of software as a medical device. ...
Posted by Michael Wonder on 15 Jan 2021
Pfizer's Xalkori (crizotinib) approved by FDA for ALK positive anaplastic large cell lymphoma in children and young adults
14 January 2021 - Xalkori is the first biomarker driven therapy for relapsed or refractory ALCL in young people. ...
Posted by Michael Wonder on 15 Jan 2021
Imfinzi approved in the EU for less frequent, fixed dose use in unresectable non-small cell lung cancer
15 January 2021 - New option extends dosing from two to four weeks, reducing medical visits and improving patient convenience ...
Posted by Michael Wonder on 15 Jan 2021
Funding of pharmaceutical innovation during and after the COVID-19 pandemic
14 January 2021 - The COVID-19 pandemic has highlighted the available mechanisms for funding research, development, manufacturing, and distribution in the ...