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RSS FeedPosted by Michael Wonder on 09 Sep 2020
Statement on AstraZeneca Oxford SARS-CoV-2 vaccine, AZD1222, COVID-19 vaccine trials temporary pause
9 September 2020 - As part of the ongoing randomised, controlled clinical trials of the AstraZeneca Oxford coronavirus vaccine, AZD1222, ...
Posted by Michael Wonder on 08 Sep 2020
BeyondSpring receives breakthrough therapy designations from both U.S. FDA and China NMPA for plinabulin in chemotherapy-induced neutropenia indication
8 September 2020 - Among the first three innovative drugs to receive breakthrough therapy designations in China. ...
Posted by Michael Wonder on 08 Sep 2020
Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients
8 September 2020 - New breakthrough device test expands Roche molecular test menu for transplant patients, enabling simultaneous testing of BK ...
Posted by Michael Wonder on 08 Sep 2020
Liminal BioSciences announces resubmission of biologics license application to U.S. FDA for Ryplazim (plasminogen)
8 September 2020 - Results from pivotal Phase 2/3 study met co-primary endpoints for improvement in trough plasminogen activity levels and ...
Posted by Michael Wonder on 08 Sep 2020
U.S. FDA approves Athena Bioscience's new drug application for Qdolo (tramadol hydrochloride) oral solution
8 September 2020 - FDA approved Qdolo (tramadol hydrochloride), an oral liquid, accommodates dosing flexibility, precise titration. ...
Posted by Michael Wonder on 08 Sep 2020
FDA approves first NGS-based companion diagnostic for RET fusion positive non-small cell lung cancer
8 September 2020 - CDx approval expands clinical utility of Oncomine Dx Target Test to identify candidates for Gavreto. ...
Posted by Michael Wonder on 08 Sep 2020
FDA sets up vaccine safeguards to counter pressure from Trump
8 September 2020 - Guidelines for emergency approval designed to insulate reviewers from influence. ...
Posted by Michael Wonder on 08 Sep 2020
Biopharma leaders unite to stand with science
8 September 2020 - Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the ...
Posted by Michael Wonder on 08 Sep 2020
RadioMedix and Curium announce FDA approval of Detectnet (copper Cu 64 dotatate injection) in the U.S.
7 September 2020 - RadioMedix and its commercial partner Curium announced today that Detectnet (copper Cu 64 dotatate injection) was approved ...
Posted by Michael Wonder on 07 Sep 2020
Leader of U.S. vaccine push says he‘ll quit if politics trumps science
3 September 2020 - Moncef Slaoui, the scientific head of Operation Warp Speed, spent 29 years making vaccines at GlaxoSmithKline. ...
Posted by Michael Wonder on 06 Sep 2020
Here's how Trump could bigfoot the FDA and get a vaccine out ahead of the science
5 September 2020 - In 1905, the agency that would later become part of the US FDA approved its first ...
Posted by Michael Wonder on 05 Sep 2020
Biocon, Mylan launch Semglee and seek biosimilar, interchangeable status
31 August 2020 - For all intents and purposes, Semglee is a biosimilar insulin, but official biosimilar status is needed to ...
Posted by Michael Wonder on 05 Sep 2020
Seniors suffer the most from antiquated FDA approval process
4 September 2020 - Americans have been heartbroken as report after report shines a light on the COVID-19 pandemic sweeping ...
Posted by Michael Wonder on 05 Sep 2020
Genentech announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion positive non-small cell lung cancer
4 September 2020 - Gavreto is a once-daily, oral precision therapy that selectively inhibits RET-altered cancers. ...
Posted by Michael Wonder on 05 Sep 2020
Ascendis Pharma announces U.S. FDA accepts biologics license application for TransCon hGH for paediatric growth hormone deficiency
4 September 2020 - Prescription Drug User Fee Act target action date of 25 June 2021. ...