Blog
RSS FeedPosted by Michael Wonder on 24 Nov 2020
Success for a third—and perhaps most important—COVID-19 vaccine
23 November 2020 - The AstraZeneca-Oxford jab is likely to be widely used around the world. ...
Posted by Michael Wonder on 24 Nov 2020
Merck submits applications for licensure of V114, the company’s investigational 15 valent pneumococcal conjugate vaccine, for use in adults to the US FDA and EMA
23 November 2020 - Merck today announced the company has submitted applications to the US FDA and EMA for licensure of ...
Posted by Michael Wonder on 24 Nov 2020
FDA approves first drug to treat rare metabolic disorder
23 November 2020 - Today, the U.S. FDA approved Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria type 1, a ...
Posted by Michael Wonder on 23 Nov 2020
COVID-19 shots could reach first Americans by mid-December, top health official says
23 November 2020 - U.S. health care workers and others recommended for the nation’s first COVID-19 inoculations could start getting shots ...
Posted by Michael Wonder on 23 Nov 2020
Theralase granted FDA fast track designation for NMIBC Phase 2 clinical study
23 November 2020 - Theralase Technologies announced today that the U.S. FDA has granted Theralase fast track designation for its ...
Posted by Michael Wonder on 23 Nov 2020
AB201 development as a potential treatment for COVID-19 receives U.S. FDA fast track designation
23 November 2020 - AB201 is the only novel compound being developed for COVID associated coagulopathy. ...
Posted by Michael Wonder on 23 Nov 2020
Kiniksa announces U.S. FDA acceptance of sBLA and priority review for rilonacept in recurrent pericarditis
23 November 2020 - Filing based on positive data from RHAPSODY, which achieved its primary and all major secondary endpoints. ...
Posted by Michael Wonder on 23 Nov 2020
Catalent signs commercial supply agreement with Blueprint Medicines following FDA approval of Gavreto (pralsetinib)
23 November 2020 - Catalent today announced that it had entered into a commercial supply agreement with Blueprint Medicines following FDA ...
Posted by Michael Wonder on 23 Nov 2020
FDA expands approval of influenza treatment to post-exposure prevention
23 November 2020 - Today, the U.S. FDA expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of ...
Posted by Michael Wonder on 23 Nov 2020
Politics, science and the remarkable race for a coronavirus vaccine
21 November 2020 - The furious race to develop a coronavirus vaccine played out against a presidential election, between a pharmaceutical ...
Posted by Michael Wonder on 21 Nov 2020
FDA approves first treatment for Hutchinson-Gilford progeria syndrome and some progeroid laminopathies
20 November 2020 - Today, the U.S. FDA approved Zokinvy (lonafarnib) capsules to reduce the risk of death due to Hutchinson-Gilford ...
Posted by Michael Wonder on 21 Nov 2020
ADC Therapeutics announces FDA accepts biologics license application and grants priority review for loncastuximab tesirine for treatment of relapsed or refractory diffuse large B-cell lymphoma
20 November 2020 - Prescription Drug User Fee Act target action date of 21 May 2021. ...
Posted by Michael Wonder on 21 Nov 2020
Pfizer and BioNTech to submit emergency use authorisation request today to the U.S. FDA for COVID-19 vaccine
20 November 2020 - In addition to today’s submission to the FDA, the companies have already initiated rolling submissions across the ...
Posted by Michael Wonder on 20 Nov 2020
Imfinzi approved in the US for less-frequent, fixed-dose use
20 November 2020 - Four-week dosing now approved in all Imfinzi indications, reducing medical visits and improving patient convenience ...
Posted by Michael Wonder on 20 Nov 2020
FDA grants breakthrough designation to 4D Path for novel cancer diagnostic solution
18 November 2020 - 4D Path today announced that the U.S. FDA has granted the company breakthrough device designation for ...