Blog
RSS FeedPosted by Michael Wonder on 12 Mar 2019
FDA approves Dupixent (dupilumab) for moderate-to-severe atopic dermatitis in adolescents
11 March 2019 - Only therapy that targets the IL-4/IL-13 pathway, a key driver of the allergic or type 2 inflammation ...
Posted by Michael Wonder on 12 Mar 2019
FDA allows first use of a novel cancer drug
4 September 2014 - The FDA on Thursday approved the first of an eagerly awaited new class of cancer drugs ...
Posted by Michael Wonder on 11 Mar 2019
Eisai and Imbrium Therapeutics announce U.S. FDA filing acceptance of new drug application for lemborexant for the treatment of insomnia
11 March 2019 - Eisai Co and Imbrium Therapeutics today announced that the U.S. FDA has accepted for review the ...
Posted by Michael Wonder on 11 Mar 2019
Allergan announces FDA acceptance of new drug application for ubrogepant for the acute treatment of migraine
11 March 2019 - Ubrogepant seeks to be the first oral calcitonin gene-related peptide receptor antagonist for the acute treatment of ...
Posted by Michael Wonder on 11 Mar 2019
TB medicine pretomanid enters regulatory review process in the United States
8 March 2019 - TB Alliance’s new drug application for the novel tuberculosis drug candidate pretomanid has been accepted for ...
Posted by Michael Wonder on 09 Mar 2019
Foamix announces FDA acceptance of new drug application for FMX101 minocycline foam for the treatment of moderate-to-severe acne
7 March 2019 - PDUFA target action date of 20 October 2019. ...
Posted by Michael Wonder on 09 Mar 2019
Marginal effects—quantifying the effect of changes in risk factors in logistic regression models
8 March 2019 - Marginal effects can be used to express how the predicted probability of a binary outcome changes ...
Posted by Michael Wonder on 08 Mar 2019
FDA to undertake priority review of Dupixent (dupilumab) for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps
8 March 2019 - The U.S. FDA has accepted for priority review the supplemental biologics license application for Dupixent (dupilumab) as ...
Posted by Michael Wonder on 08 Mar 2019
FDA grants Genentech’s Tecentriq in combination with Abraxane accelerated approval for people with PD-L1-positive, metastatic triple-negative breast cancer
8 March 2019 - This Tecentriq combination is the first cancer immunotherapy regimen approved for breast cancer. ...
Posted by Michael Wonder on 08 Mar 2019
FDA accepts supplemental biologics license applications for Botox (onabotulinumtoxinA) for paediatric patients with upper and lower limb spasticity
7 March 2019 - Applications seek to extend use of Botox for patients 2 to 17 years old. ...
Posted by Michael Wonder on 07 Mar 2019
Genentech submits supplemental new drug application to FDA for Venclexta plus Gazyva for previously untreated chronic lymphocytic leukaemia with co-existing medical conditions
7 March 2019 - Combination was granted breakthrough therapy designation, the fifth for Venclexta. ...
Posted by Michael Wonder on 07 Mar 2019
FDA accepts Genentech’s supplemental new drug application for Xofluza (baloxavir marboxil) for the treatment of influenza in people at high risk of complications
5 March 2019 - Xofluza would be the first antiviral medicine approved specifically for the high-risk population. ...
Posted by Michael Wonder on 07 Mar 2019
Gottlieb: drug rebates not benefiting sicker patients
6 March 2019 - Food and Drug Administration (FDA) Commissioner Scott Gottlieb said Wednesday that drug discounts known as rebates ...
Posted by Michael Wonder on 07 Mar 2019
Many local governments shrug off FDA warning about Canadian drug imports
7 March 2019 - Cities and local governments in several states said they will continue to use a Canadian company ...
Posted by Michael Wonder on 07 Mar 2019
Statement from FDA Commissioner on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these products
7 March 2019 - We’re at a critical point for the future of biosimilars in the U.S. Millions of American ...