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RSS FeedPosted by Michael Wonder on 08 Sep 2021
Intelivation Technologies received FDA approval for the Advantage-C PEEK cervical interbody fusion device
8 September 2021 - Intelivation Technologies announced today that they have achieved FDA 510(k) Clearance of the Advantage-C PEEK cervical ...
Posted by Michael Wonder on 08 Sep 2021
Phathom Pharmaceuticals submits two NDAs to U.S. FDA for vonoprazan-based treatment regimens for the treatment of H. pylori infection
8 September 2021 - Phathom Pharmaceuticals announced today that it has submitted two new drug applications to the U.S. FDA for ...
Posted by Michael Wonder on 08 Sep 2021
FDA grants Madorra breakthrough device designation status for treatment of moderate to severe vulvovaginal atrophy
8 September 2021 - Clinical trials of Madorra therapy system show promising results for treatment of vulvovaginal atrophy. ...
Posted by Michael Wonder on 08 Sep 2021
HiberCell receives fast track designation from FDA for first in human studies of PERK inhibitor (PERKi) HC-5404-FU
8 September 2021 - C-5404-FU PERKi program is currently in a Phase 1a clinical trial for the treatment of solid ...
Posted by Michael Wonder on 07 Sep 2021
TGA approves new cancer medicine
7 September 2021 - Luspatercept (Reblozyl) is used to treat patients with certain transfusion-dependent anaemias. ...
Posted by Michael Wonder on 07 Sep 2021
U.S. FDA accepts for priority review supplemental new drug application for Oxbryta (voxelotor) for the treatment of sickle cell disease in children ages 4 to 11
7 September 2021 - New drug application for Oxbryta dispersible tablets also accepted for priority review. ...
Posted by Michael Wonder on 06 Sep 2021
EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty
6 September 2021 - EMA has started evaluating an application for the use of a booster dose of Comirnaty to be ...
Posted by Michael Wonder on 06 Sep 2021
Congress “concerned by apparent anomalies” around FDA’s approval of Aduhelm
6 September 2021 - Congress demands more information from the FDA on its controversial approval of Biogen’s Alzheimer’s drug and its ...
Posted by Michael Wonder on 06 Sep 2021
Statement on Moderna COVID-19 vaccine
6 September 2021 - Medicines Australia welcomes the TGA provisional approval for the COVID-19 vaccine, Spikevax (Moderna) for Australia. The ...
Posted by Michael Wonder on 05 Sep 2021
America desperately needs a much better FDA
2 September 2021 - In the early 1960s, an unflappable FDA scientist named Frances Kelsey spared the nation from the horrors ...
Posted by Michael Wonder on 05 Sep 2021
Moderna announces submission of data to European Medicines Agency for its COVID-19 vaccine booster
3 September 2021 - mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40 times against ...
Posted by Michael Wonder on 04 Sep 2021
GSK’s shingles vaccine Shingrix gains UK license
2 September 2021 - GlaxoSmithKline's Shingrix has been licensed in the UK for the prevention of shingles in adults aged ...
Posted by Michael Wonder on 04 Sep 2021
COVID-19 vaccine: Spikevax (elasomeran)
4 September 2021 - On 3 September 2021, the TGA granted provisional approval to Moderna Australia for the use of ...
Posted by Michael Wonder on 03 Sep 2021
Impel NeuroPharma announces U.S. FDA approval of Trudhesa (dihydroergotamine mesylate) nasal spray for the acute treatment of migraine
3 September 2021 - Commercial launch of Trudhesa is planned for early October 2021. ...
Posted by Michael Wonder on 03 Sep 2021
Ultomiris approved in the EU for children and adolescents with paroxysmal nocturnal haemoglobinuria
3 September 2021 - Approval based on interim results from Phase 3 trial demonstrating complete terminal complement inhibition with reduced ...