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RSS FeedPosted by Michael Wonder on 13 Mar 2019
Janssen submits application to U.S. FDA seeking approval of Darzalex (daratumumab) combination therapy for patients with newly diagnosed multiple myeloma who are transplant ineligible
12 March 2019 - Application supported by the Phase 3 MAIA study being reviewed under the FDA Real-Time Oncology Review pilot ...
Posted by Michael Wonder on 13 Mar 2019
Aerie Pharmaceuticals announces U.S. FDA approval of Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% for the reduction of intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension
12 March 2019 - Aerie Pharmaceuticals today announced that the U.S. FDA has approved Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% ...
Posted by Michael Wonder on 12 Mar 2019
FDA approves a new generic valsartan
12 March 2019 - Today, the U.S. FDA approved a new generic of Diovan (valsartan). ...
Posted by Michael Wonder on 12 Mar 2019
Cancer Institute's Sharpless tapped as acting chief of FDA
12 March 2019 - Ned Sharpless, the director of the National Cancer Institute, will be named temporary chief of the ...
Posted by Michael Wonder on 12 Mar 2019
U.S. FDA approves Pfizer's oncology biosimilar Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin
11 March 2019 - Pfizer today announced the United States FDA has approved Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin (trastuzumab), ...
Posted 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. ...