Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 01 Sep 2020
Roche receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the fight against HIV/AIDS
1 September 2020 - Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management ...
Posted by Michael Wonder on 01 Sep 2020
Athenex announces FDA acceptance for filing of U.S. NDA for oral paclitaxel and encequidar in metastatic breast cancer with priority review
1 September 2020 - FDA grants priority review and sets PDUFA target action date of 28 February 2021. ...
Posted by Michael Wonder on 01 Sep 2020
Coronavirus vaccine before election unlikely — Dr. Gottlieb on FDA chief’s possible fast track
31 August 2020 - The former FDA commissioner said the more effective the vaccine is, and the more serious the U.S. ...
Posted by Michael Wonder on 01 Sep 2020
FDA approves first-of-its-kind automated insulin delivery and monitoring system for use in young paediatric patients
31 August 2020 - Today, the U.S. FDA approved the MiniMed 770G System, a hybrid closed loop diabetes management device that ...