Blog
RSS FeedPosted 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
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
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 ...
Posted by Michael Wonder on 02 Sep 2020
Mirum Pharmaceuticals initiates rolling submission of a new drug application for maralixibat for the treatment of cholestatic pruritus in patients with Alagille syndrome and launches expanded access program
1 September 2020 - Maralixibat would be the first treatment available for use in Alagille syndrome, if approved. ...
Posted by Michael Wonder on 01 Sep 2020
FDA approves weekly therapy for adult growth hormone deficiency
1 September 2020 - On 28 August 2020, the U.S. FDA approved Sogroya (somapacitan) for adults with growth hormone deficiency. ...
Posted by Michael Wonder on 01 Sep 2020
FDA approves Onureg (azacitidine tablets) for acute myeloid leukaemia
1 September 2020 - Today, the FDA approved azacitidine tablets (Onureg, Celgene) for continued treatment of patients with acute myeloid ...
Posted by Michael Wonder on 01 Sep 2020
FDA accepts Vertex’s supplemental new drug applications for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) for additional CFTR mutations
1 September 2020 - More than 600 people with certain rare cystic fibrosis mutations could become newly eligible for Trikafta, Symdeko ...