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RSS FeedPosted by Michael Wonder on 11 Jul 2018
FDA accepts biologics license application for subcutaneous formulation of Herceptin
11 July 2018 - Halozyme Therapeutics today announced that the US FDA has accepted a biologics license application from Genentech, a ...
Posted by Michael Wonder on 09 Jul 2018
Enzyvant announces initiation of RVT-802 rolling BLA submission for the treatment of complete DiGeorge anomaly
9 July 2018 - Completion of rolling BLA submission anticipated by end of 2018. ...
Posted by Michael Wonder on 05 Jul 2018
Theratechnologies submits novel single-vial formulation of Egrifta (tesamorelin for injection) for FDA approval
4 July 2018 - Theratechnologies today announced that it has filed a supplemental new drug application with the FDA for ...
Posted by Michael Wonder on 02 Jul 2018
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) in combination with chemotherapy as first-line treatment for metastatic squamous non-small cell lung cancer
2 July 2018 - Application based on data from pivotal Phase 3 KEYNOTE-407 trial. ...
Posted by Michael Wonder on 02 Jul 2018
Ocular Therapeutix announces NDA resubmission of Dextenza
29 June 2018 - Ocular Therapeutix has announced the resubmission of the Company’s new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 28 Jun 2018
Jazz Pharmaceuticals announces FDA acceptance of supplemental new drug application for Xyrem (sodium oxybate) to treat cataplexy and excessive daytime sleepiness in paediatric narcolepsy patients
27 June 2018 - Jazz Pharmaceuticals today announced that the U.S. FDA accepted for priority review its supplemental new drug application ...
Posted by Michael Wonder on 26 Jun 2018
FDA accepts supplemental biologics license application for Merck’s Keytruda (pembrolizumab) as adjuvant therapy in advanced melanoma
25 June 2018 - Application based on recurrence-free survival data from pivotal Phase 3 EORTC1325/KEYNOTE-054 trial. ...
Posted by Michael Wonder on 26 Jun 2018
Stemline Therapeutics announces completion of rolling BLA submission for Elzonris (tagraxofusp; SL-401) for the treatment of BPDCN
25 June 2018 - Stemline Therapeutics announced today that it has completed submission of a rolling biologics license application to the ...
Posted by Michael Wonder on 26 Jun 2018
Historic new drug application for the use of Scenesse in rare metabolic disorder EPP
25 June 2018 - Priority review requested to FDA. ...
Posted by Michael Wonder on 25 Jun 2018
Imbruvica (ibrutinib) supplemental new drug application accepted for review by U.S. FDA with potential to broaden treatment use as a combination treatment option with rituximab in Waldenström's macroglobulinemia, a rare form of blood cancer
25 June 2018 - The filing is based on data from the Phase 3 iNNOVATE study, which suggest that IMBRUVICA plus ...
Posted by Michael Wonder on 21 Jun 2018
U.S. FDA accepts application for Opdivo plus low-dose Yervoy for treatment of first-line non-small cell lung cancer in patients with tumour mutational burden ≥10 mut/Mb
21 June 2018 - First-ever application for an I-O/I-O combination in lung cancer to be accepted. ...
Posted by Michael Wonder on 20 Jun 2018
Alexion submits application for priority review and approval of ALXN1210 as a treatment for patients with paroxysmal nocturnal haemoglobinuria in the U.S.
19 June 2018 - Submission in the European Union on track for mid-year and in Japan for the second half of ...
Posted by Michael Wonder on 18 Jun 2018
Celltrion completes resubmission to FDA for proposed trastuzumab biosimilar
18 June 2018 - Celltrion made a resubmission for the U.S. FDA approval of CT-P6, a proposed biosimilar to Herceptin ...
Posted by Michael Wonder on 16 Jun 2018
Motif Bio submits NDA for iclaprim
14 June 2018 - Motif Bio today announced the completion of its rolling submission of a new drug application to ...
Posted by Michael Wonder on 14 Jun 2018
FDA grants priority review to Merck’s supplemental biologics license application for Gardasil 9 in women and men ages 27 to 45 for the prevention of certain HPV-related cancers and diseases
13 June 2018 - Merck today announced that the U.S. FDA has accepted for review a new supplemental biologics license application ...