Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 05 Sep 2020
Kite submits supplemental biologics license application to U.S. FDA for Yescarta in relapsed or refractory indolent non-Hodgkin's lymphomas
4 September 2020 - If approved, Yescarta would be the first CAR T therapy for patients with relapsed or refractory ...
Posted by Michael Wonder on 04 Sep 2020
Vaccine makers plan public stance to counter pressure on FDA
5 September 2020 - Companies involved include Pfizer, Moderna, Sanofi and others. ...
Posted by Michael Wonder on 04 Sep 2020
PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids
4 September 2020 - A review by EMA’s safety committee has confirmed that 5 mg ulipristal acetate (Esmya and generic ...
Posted by Michael Wonder on 04 Sep 2020
HHS Secretary Azar says 1 November coronavirus vaccine deadline has ‘nothing to do with elections’
3 September 2020 - Azar said the deadline was made by Dr. Nancy Messonnier, director of the CDC’s National Center for ...
Posted by Michael Wonder on 04 Sep 2020
Fast tracking a vaccine: How comfortable are Americans?
4 September 2020 - Fast tracking vaccines to fight COVID-19, something the federal government has promised, may not be viewed ...
Posted by Michael Wonder on 03 Sep 2020
Health Department moving TGA to new $60 million Canberra Airport campus
4 September 2020 - The Health Department will leave its ageing Symonston facility in 2022 for a new $60 million purpose ...
Posted by Michael Wonder on 03 Sep 2020
TGA says it is already in discussions with pharmaceutical companies developing COVID vaccines
4 September 2020 - Australia's medicines regulator isn't considering approving any treatments for COVID-19 at the moment, but it's spending ...
Posted by Michael Wonder on 03 Sep 2020
FDA approves additional doses of Trulicity (dulaglutide) for the treatment of type 2 diabetes mellitus
3 September 2020 - AWARD-11 showed 3.0 mg and 4.5 mg doses led to additional blood sugar control; as a secondary ...
Posted by Michael Wonder on 03 Sep 2020
C.D.C. tells states how to prepare for COVID-19 vaccine by early November
2 September 2020 - As President Trump pushes the possibility of a vaccine this year, the C.D.C. has outlined technical scenarios ...
Posted by Michael Wonder on 03 Sep 2020
Debate rages over whether FDA should use emergency powers to clear a coronavirus vaccine early
3 September 2020 - Speeding the process could save lives, but some say it might also make it easier for the ...
Posted by Michael Wonder on 03 Sep 2020
Second Trump appointee out at FDA amid credibility concerns
2 September 2020 - A second Trump administration appointee has been ousted at the Food and Drug Administration after the agency’s ...
Posted by Michael Wonder on 03 Sep 2020
California may be the first state to develop its own generic drugs
1 September 2020 - California is poised to become the first state to develop its own line of generic drugs, ...
Posted by Michael Wonder on 02 Sep 2020
23 attorneys general urge FDA to ensure affordable access to insulin
3 September 2020 - Michigan Attorney General Dana Nessel has joined a bipartisan coalition of 23 attorneys general in signing ...
Posted by Michael Wonder on 02 Sep 2020
WHO touts steroids as effective treatment to combat COVID-19
2 September 2020 - An analysis of seven international trials has found that treating critically-ill COVID-19 patients with steroids can ...