Blog
RSS FeedPosted by Michael Wonder on 01 Jun 2020
U.S. FDA approves new paediatric formulation of Sirturo (bedaquiline) as part of combination therapy to treat children with pulmonary multidrug-resistant tuberculosis
27 May 2020 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. FDA has granted ...
Posted by Michael Wonder on 01 Jun 2020
Orphazyme initiates rolling submission of new drug application for arimoclomol with US FDA in Niemann-Pick disease type C
29 May 2020 - EMA marketing authorisation application submission expected in H2 2020. ...
Posted by Michael Wonder on 01 Jun 2020
Menlo Therapeutics receives FDA approval of Zilxi (minocycline) 1.5 % topical foam, the first topical minocycline treatment for rosacea
29 May 2020 - Zilxi now approved for inflammatory lesions of rosacea in adults. ...
Posted by Michael Wonder on 31 May 2020
FDA approves Genentech’s Tecentriq in combination with Avastin for people with the most common form of liver cancer
29 May 2020 - Application approved under FDA’s Project Orbis initiative and Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 31 May 2020
FDA approves the first oral medication for the management of heavy menstrual bleeding due to uterine fibroids in pre-menopausal women
29 May 2020 - Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) is expected to be available in the U.S. ...
Posted by Michael Wonder on 31 May 2020
Lilly's Cyramza (ramucirumab) receives FDA approval as first-line treatment for metastatic EGFR mutated non-small cell lung cancer
29 May 2020 - Cyramza, in combination with erlotinib, now approved for the treatment of people with untreated metastatic non-small cell ...
Posted by Michael Wonder on 29 May 2020
FDA approves first drug to image tau pathology in patients being evaluated for Alzheimer’s disease
28 May 2020 - Today, the U.S. FDA approved Tauvid (flortaucipir F18) for intravenous injection, the first drug used to help ...
Posted by Michael Wonder on 29 May 2020
FDA accepts for review Fresenius Kabi’s first biosimilar regulatory submission for MSB11455, a biosimilar candidate of pegfilgrastim
27 May 2020 - Fresenius Kabi announced today that the U.S. FDA has accepted for review the company’s biologics license ...
Posted by Michael Wonder on 28 May 2020
Fauci warns about hydroxychloroquine
27 May 2020 - Top administration expert airs differences with Trump on pandemic response. ...
Posted by Michael Wonder on 28 May 2020
‘Vaccine nationalism’: a new dynamic in the race to quash coronavirus
27 May 2020 - International pursuit for a shot is shifting into a contest of which world power can immunise its ...
Posted by Michael Wonder on 28 May 2020
Nonparametric statistical analysis
26 May 2020 - Many statistical methods start with a statistical assumption that the distribution of measured values can be summarised ...
Posted by Michael Wonder on 28 May 2020
Modelling epidemics with compartmental models
27 May 2020 - During epidemics, there is a critical need to understand both the likely number of infections and their ...
Posted by Michael Wonder on 28 May 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases announce submission of biologics license application to U.S. FDA for pegunigalsidase alfa for the treatment of Fabry disease
28 May 2020 - Protalix BioTherapeutics together with its development and commercialisation partner Chiesi Global Rare Diseases, today announced the submission ...
Posted by Michael Wonder on 28 May 2020
Cardiff Oncology announces fast track designation granted by the FDA to onvansertib for second-line treatment of KRAS mutated colorectal cancer
28 May 2020 - Fast Track designation for onvansertib in KRAS mutated metastatic colorectal cancer underscores the urgent need for new ...
Posted by Michael Wonder on 28 May 2020
Technegas – US FDA new drug application – next milestone in approval process successfully achieved
27 May 2020 - Cyclopharm is pleased to announce that the Company, through its wholly owned subsidiary Cyclomedica Australia, has been ...