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RSS FeedPosted by Michael Wonder on 20 Dec 2018
ADMA Biologics provides regulatory update on Bivigam PAS submissions
19 December 2018 - FDA issues complete response letter for drug substance, approves supplement for drug product. ...
Posted by Michael Wonder on 20 Dec 2018
DBV Technologies provides update on Viaskin Peanut for children four to 11 years of age
19 December 2018 - Application withdrawn following discussions with FDA regarding insufficient data on manufacturing procedures and quality controls. ...
Posted by Michael Wonder on 18 Dec 2018
UroGen Pharma initiates rolling submission of new drug application for UGN-101 for the treatment of low-grade upper tract urothelial cancer
17 December 2018 - Company expects to complete submission by mid-2019, with potential approval in 2019. ...
Posted by Michael Wonder on 18 Dec 2018
Alkermes and Biogen announce submission of a new drug application to U.S. FDA for diroximel fumarate in multiple sclerosis
17 December 2018 - Alkermes and Biogen today announced that Alkermes has submitted a new drug application to the U.S. ...
Posted by Michael Wonder on 17 Dec 2018
Amgen submits biologics license application for ABP 710 (biosimilar infliximab) to US Food And Drug Administration
17 December 2018 - Filing for ABP 710, a biosimilar candidate to infliximab, supported by Phase 3 study in patients with ...
Posted by Michael Wonder on 11 Dec 2018
Intra-Cellular Therapies announces FDA acceptance of new drug application for lumateperone for the treatment of schizophrenia
11 December 2018 - Intra-Cellular Therapies today announced that the U.S. FDA has accepted for review its new drug application for ...
Posted by Michael Wonder on 10 Dec 2018
Pfenex submits new drug application to U.S. FDA seeking approval of PF708 for the treatment of osteoporosis
10 December 2018 - Submitted as a 505(b)(2) NDA with an expected ten month review. ...
Posted by Michael Wonder on 10 Dec 2018
Blue Earth Diagnostics announces U.S. FDA filing acceptance of supplemental new drug application for 18F-fluciclovine PET Imaging in Glioma
10 December 2018 - The application seeks to expand Axumin (fluciclovine F 18) label for use in detection and continuing ...
Posted by Michael Wonder on 04 Dec 2018
Shield Therapeutics announces the new drug application for Feraccru has been accepted for filing and review by the FDA
3 December 2018 - Shield Therapeutics today announces that the US FDA has accepted for review the new drug application ...
Posted by Michael Wonder on 03 Dec 2018
Novartis announces FDA filing acceptance and priority review of AVXS-101, a one-time treatment designed to address the genetic root cause of SMA Type 1
3 December 2018 - The AVXS-101, now known as Zolgensma (onasemnogene abeparvovec-xxxx), filing is supported by data from the START trial ...
Posted by Michael Wonder on 01 Dec 2018
FDA accepts filing of new oestrogen-free oral contraceptive developed by Exeltis
29 November 2018 - This new method of contraception could offer an improved bleeding profile and greater flexibility for female population. ...
Posted by Michael Wonder on 27 Nov 2018
Biohaven announces FDA acceptance of 505(B)(2) NDA filing for BHV-0223, a novel sublingual form of riluzole for the treatment of amyotrophic lateral sclerosis
26 November 2018 - If approved, BHV-0223 would become the only formulation of riluzole that does not require swallowing tablets or ...
Posted by Michael Wonder on 26 Nov 2018
SK Biopharmaceuticals submits epilepsy drug candidate for approval to US FDA
26 November 2018 - SK Biopharmaceuticals, the new drug development unit of South Korea’s telecom-to-energy conglomerate SK Group, said Monday ...
Posted by Michael Wonder on 22 Nov 2018
Allergan announces FDA acceptance of supplemental new drug application for Avycaz (ceftazidime and avibactam)
20 November 2018 - Application seeks to expand the Avycaz label to include treatment of cUTI and cIAI in paediatric ...
Posted by Michael Wonder on 21 Nov 2018
IntelGenx announces FDA’s acceptance of resubmission of new drug application for Rizaport
20 November 2018 - PDUFA goal date of 1 April 2019. ...