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RSS FeedPosted by Michael Wonder on 21 Oct 2019
Farxiga approved in the US to reduce the risk of hospitalisation for heart failure in patients with type-2 diabetes
21 October 2019 - AstraZeneca today announced that the US FDA has approved Farxiga (dapagliflozin) to reduce the risk of ...
Posted by Michael Wonder on 19 Oct 2019
Criticism won’t slow targeted cancer drug reviews: FDA official
18 October 2019 - FDA’s accelerated approval pathway has faced criticism it’s not really helping patients. ...
Posted by Michael Wonder on 19 Oct 2019
Alexion receives FDA approval for Ultomiris (ravulizumab-cwvz) for atypical haemolytic uremic syndrome
18 October 2019 - At 26 weeks, 54% of adults and 71% of children treated with Ultomiris demonstrated complete thrombotic microangiopathy ...
Posted by Michael Wonder on 19 Oct 2019
Foamix receives FDA approval of Amzeeq topical minocycline treatment for millions of moderate to severe acne sufferers
18 October 2019 - Amzeeq is the first ever FDA approved topical form of minocycline. ...
Posted by Michael Wonder on 18 Oct 2019
Nplate (romiplostim) now approved for earlier use in adults with immune thrombocytopenia
18 October 2019 - Amgen today announced that the U.S. FDA approved Amgen's supplemental biologics license application for Nplate (romiplostim) to ...
Posted by Michael Wonder on 17 Oct 2019
Complexity in assessing the benefit versus risk of vaccines: experience with rotavirus and dengue virus vaccines
17 October 2019 - The remarkable contribution of immunisation programs to public health is recognised by most people, including those who ...
Posted by Michael Wonder on 17 Oct 2019
Have FDA actions to ease generic drug shortages taken effect yet?
16 October 2019 - On Wednesday, the FDA said fiscal year 2018 saw a record number of generic drug approvals. ...
Posted by Michael Wonder on 17 Oct 2019
Foamix announces FDA acceptance of its new drug application for FMX103 minocycline foam for the treatment of moderate-to-severe papulopustular rosacea
17 October 2019 - PDUFA target action date of 2 June 2020 ...
Posted by Michael Wonder on 17 Oct 2019
Genentech announces FDA approval of Xofluza (baloxavir marboxil) for people at high risk of developing influenza-related complications
17 October 2019 - Single-dose Xofluza is the first and only antiviral medicine indicated specifically for patients at high risk of ...
Posted by Michael Wonder on 17 Oct 2019
Pelosi’s drug pricing plan puts medical innovation at risk
17 October 2019 - The future of medical innovation in America is at a crossroads. ...
Posted by Michael Wonder on 17 Oct 2019
Trastuzumab deruxtecan (DS-8201) granted FDA priority review for treatment of patients with HER2 positive metastatic breast cancer
17 October 2019 - Daiichi Sankyo and AstraZeneca today announced that the U.S. FDA has accepted for review the biologics ...
Posted by Michael Wonder on 16 Oct 2019
Statement on continued progress enhancing patient access to high-quality, low-cost generic drugs
16 October 2019 - FDA generic drug approvals reach record high in fiscal year 2019. ...
Posted by Michael Wonder on 16 Oct 2019
ViiV Healthcare submits supplemental new drug application to US FDA for use of Dovato in virologically suppressed adults with HIV-1
16 October 2019 - ViiV Healthcare announced the submission of a supplemental New Drug Application to the US FDA for ...
Posted by Michael Wonder on 16 Oct 2019
RWE to supplement RCTs: FDA projects continue
15 October 2019 - The US FDA has been working with several different data and research companies to further its ...
Posted by Michael Wonder on 16 Oct 2019
ProQR receives rare paediatric disease designation from FDA for sepofarsen for the treatment of LCA10
15 October 2019 - ProQR Therapeutics today announced that it received rare paediatric disease designation from the U.S. FDA for ...