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RSS FeedPosted by Michael Wonder on 07 Aug 2017
Drugs cleared through the FDA’s expedited review offer greater gains than drugs approved by conventional process
7 August 2017 - Chambers et al. investigated whether drugs approved by the FDA through expedited review have offered larger ...
Posted by Michael Wonder on 07 Aug 2017
Teva announces FDA approval of Qvar RediHaler (beclomethasone dipropionate HFA) inhalation aerosol
7 August 2017 - Maintenance treatment option designed to eliminate the need for hand-breath co-ordination during inhalation. ...
Posted by Michael Wonder on 07 Aug 2017
Take the generic, patients are told. Until they are not.
6 August 2017 - It’s standard advice for consumers: if you are prescribed a medicine, always ask if there is ...
Posted by Michael Wonder on 06 Aug 2017
FDA’S generic drug labelling rule delayed again
4 August 2017 - The FDA won’t be issuing a controversial final rule on label changes concerning generic drug safety ...
Posted by Michael Wonder on 04 Aug 2017
Dynavax provides U.S. regulatory update on Heplisav following FDA Advisory Committee meeting
3 August 2017 - Dynavax Technologies Corporation today announced that the U.S. FDA has requested more detailed information about the company's ...
Posted by Michael Wonder on 04 Aug 2017
Portola Pharmaceuticals announces resubmission of biologics license application for AndexXa (andexanet alfa)
3 August 2017 - Portola Pharmaceuticals today announced that on August 3, 2017 it resubmitted its Biologics License Application (BLA) ...
Posted by Michael Wonder on 04 Aug 2017
FDA grants Genentech’s Alecensa priority review for initial treatment of people with ALK positive lung cancer
4 August 2017 - Genentech announced today that the U.S. FDA has accepted the company’s supplemental new drug application and granted ...
Posted by Michael Wonder on 04 Aug 2017
Senate passes F.D.A. funding and ‘right to try’ drug bills
3 August 2017 - The Senate on Thursday gave final approval to legislation to finance the Food and Drug Administration, ...
Posted by Michael Wonder on 03 Aug 2017
A rush for immunotherapy cancer drugs means new bedfellows
3 August 2017 - Fierce rivals in pharma are co-operating. ...
Posted by Michael Wonder on 03 Aug 2017
Addressing antimicrobial resistance and stewardship: the Priority Antimicrobial Value and Entry (PAVE) award
3 August 2017 - Antimicrobial-resistant infections affect more than 2 million people annually in the United States alone, accounting for an ...
Posted by Michael Wonder on 03 Aug 2017
FDA approves Mavyret for Hepatitis C
3 August 2017 - The U.S. FDA today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus ...
Posted by Michael Wonder on 03 Aug 2017
FDA approves first treatment for certain types of poor-prognosis acute myeloid leukaemia
3 August 2017 - The U.S. FDA today approved Vyxeos for the treatment of adults with two types of acute myeloid ...
Posted by Michael Wonder on 03 Aug 2017
U.S. FDA approves expanded labeling for Epclusa (sofosbuvir/velpatasvir) for the treatment of chronic hepatitis C in patients co-infected with HIV
1 August 2017 - New data for first approved pan-genotypic once-daily single tablet regimen for chronic hepatitis C virus infection. ...
Posted by Michael Wonder on 03 Aug 2017
US FDA accepts regulatory submission for acalabrutinib and grants priority review
2 August 2017 - AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the ...
Posted by Michael Wonder on 02 Aug 2017
Evidence for health decision making — beyond randomised, controlled trials
2 August 2017 - A core principle of good public health practice is to base all policy decisions on the highest-quality ...