Blog
RSS FeedPosted by Michael Wonder on 12 Mar 2020
Acacia Pharma announces brief extension of FDA review period for NDA for Byfavo, an ultra-short acting and reversible anesthetic for procedural sedation
12 March 2020 - Acacia Pharma announces that the US FDA has extended the review period for the new drug ...
Posted by Michael Wonder on 09 Mar 2020
Athenex announces FDA acceptance for filing of U.S. NDA for tirbanibulin ointment in actinic keratosis
9 March 2020 - PDUFA date of 30 December 2020. ...
Posted by Michael Wonder on 09 Mar 2020
U.S. FDA accepts biologics license application for Mylan and Biocon's proposed biosimilar bevacizumab for review
9 March 2020 - Biocon and Mylan today announced that the U.S. FDA has accepted Mylan’s biologics license application for ...
Posted by Michael Wonder on 05 Mar 2020
Urovant Sciences announces U.S. FDA acceptance of new drug application for vibegron for the treatment of overactive bladder
5 March 2020 - Urovant Sciences today announced that the U.S. FDA has accepted for review the company’s new drug ...
Posted by Michael Wonder on 04 Mar 2020
Zosano Pharma announces FDA acceptance of 505(b)(2) new drug application for Qtrypta for the acute treatment of migraine
4 March 2020 - Zosano Pharma today announced that the U.S. FDA has accepted the company’s new drug application for ...
Posted by Michael Wonder on 03 Mar 2020
Mallinckrodt initiates rolling submission of new drug application to the U.S. FDA for terlipressin for the treatment of patients with hepatorenal syndrome type 1
2 March 2020 - Terlipressin would be the first FDA-approved treatment option in the United States for patients with HRS-1 if ...
Posted by Michael Wonder on 03 Mar 2020
KemPharm submits KP415 NDA to the FDA for the treatment of ADHD
2 March 2020 - If approved, KemPharm believes that KP415 may address several unmet needs, including earlier onset of action ...
Posted by Michael Wonder on 02 Mar 2020
FDA accepts MorphoSys' biologics license application and grants priority review for tafasitamab and lenalidomide for the treatment of relapsed/refractory DLBCL
2 March 2020 - MorphoSys announced today that the U.S. FDA accepted filing of MorphoSys' biologics license application and granted priority ...
Posted by Michael Wonder on 02 Mar 2020
U.S. FDA accepts regulatory submission for tanezumab, a potential first-in-class treatment for patients with chronic pain due to moderate-to-severe osteoarthritis
2 February 2020 - Pfizer and Eli Lilly today announced that the U.S. FDA accepted for review a Biologics License Application ...
Posted by Michael Wonder on 27 Feb 2020
Ultragenyx and Kyowa Kirin announce FDA acceptance and priority review designation of supplemental biologics license application for Crysvita (burosumab) for tumour-induced osteomalacia
27 February 2020 - Ultragenyx Pharmaceutical and Kyowa Kirin Co today announced that the U.S. FDA has accepted for review the ...
Posted by Michael Wonder on 27 Feb 2020
Zogenix announces FDA extension of review period for Fintepla in Dravet syndrome
27 February 2020 - Zogenix today announced that the U.S. FDA has extended the review period for the new drug application ...
Posted by Michael Wonder on 25 Feb 2020
FDA accepts Genentech’s biologics license application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer
24 February 2020 - Fixed-dose combination is administered under the skin in just minutes, compared to hours with intravenous administration, significantly ...
Posted by Michael Wonder on 24 Feb 2020
U.S. FDA accepts GSK’s application for Zejula (niraparib) for first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer
24 February 2020 - Submission based on data from the Phase III PRIMA clinical study that demonstrated clinically-meaningful outcomes of niraparib ...
Posted by Michael Wonder on 24 Feb 2020
Takeda announces U.S. FDA grants priority review for supplemental new drug application for Alunbrig (brigatinib) as a first-line treatment for ALK+ metastatic non-small cell lung cancer
25 February 2020 - Prescription Drug User Fee Act target action date set for 23 June 2020. ...
Posted by Michael Wonder on 24 Feb 2020
Novartis announces FDA and EMA filing acceptance of ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis
24 February 2020 - Filings are supported by Phase III ASCLEPIOS I and II studies, where ofatumumab showed highly significant and ...