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RSS FeedPosted by Michael Wonder on 25 Oct 2022
IntelGenx receives FDA GDUFA date for Xiromed partnered development candidate, buprenorphine buccal film
25 October 2022 - IntelGenx today announced that its previously undisclosed development candidate, buprenorphine buccal film, for which an abbreviated ...
Posted by Michael Wonder on 25 Oct 2022
Hugel Aesthetics receives FDA acceptance of BLA resubmission for letibotulinumtoxinA for injection for glabellar lines
25 October 2022 - PDUFA goal date set for 6 April 2023. ...
Posted by Michael Wonder on 24 Oct 2022
Invivoscribe files sPMA with the FDA for use of the LeukoStrat CDx FLT3 mutation assay to select patients with newly diagnosed FLT3-ITD positive AML
24 October 2022 - Invivoscribe is pleased to announce that they have filed a supplemental pre-market approval submission with the ...
Posted by Michael Wonder on 24 Oct 2022
Novaliq announces FDA acceptance of the new drug application for CyclASol for the treatment of dry eye disease
25 October 2022 - PDUFA target action date is 8 June 2023. ...
Posted by Michael Wonder on 21 Oct 2022
Silverback Therapeutics announces the FDA’s acceptance of ARS Pharmaceuticals’ NDA for neffy (epinephrine nasal spray) for the treatment of allergic reactions (type I) including anaphylaxis
21 October 2022 - neffy has potential to be the first non-injectable medicine indicated to treat allergic reactions (type I) including ...
Posted by Michael Wonder on 21 Oct 2022
US FDA accepts supplemental new drug application for Camzyos (mavacamten) in symptomatic obstructive hypertrophic cardiomyopathy to reduce the need for septal reduction therapy
21 October 2022 - Application based on results from the Phase 3 VALOR-HCM study. ...
Posted by Michael Wonder on 21 Oct 2022
Revance submits supplemental biologics license application for Daxxify (daxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia
20 October 2022 - Supplemental biologics license application filing based on the pivotal ASPEN Phase 3 program demonstrating Daxxify's median ...
Posted by Michael Wonder on 17 Oct 2022
Minerva Neurosciences receives refusal to file letter from FDA for its new drug application for roluperidone for the treatment of negative symptoms in schizophrenia
17 October 2022 - Minerva Neurosciences today announced that the company has received a refusal to file letter from the ...
Posted by Michael Wonder on 17 Oct 2022
Biogen announces FDA’s 3 month extension of review period for the new drug application for tofersen
17 October 2022 - The new Prescription Drug User Fee Act action date set by the FDA is 25 April ...
Posted by Michael Wonder on 13 Oct 2022
FDA accepts BioMarin's biologics license application for valoctocogene roxaparvovec AAV gene therapy for adults with severe haemophilia A
12 October 2022 - PDUFA target action date is 31 March 2023 ...
Posted by Michael Wonder on 12 Oct 2022
Eylea (aflibercept) injection sBLA for treatment of retinopathy of prematurity accepted for FDA priority review
12 October 2022 - Regeneron Pharmaceuticals today announced the US FDA has accepted for priority review the supplemental biologics license application ...
Posted by Michael Wonder on 11 Oct 2022
U.S. FDA accepts for priority review the supplemental biologics license application for Gilead’s Trodelvy for pre-treated HR+/HER2- metastatic breast cancer
11 October 2022 - Supplemental biologics license application based on statistically significant and clinically meaningful overall survival and progression-free survival results ...
Posted by Michael Wonder on 10 Oct 2022
Supernus provides regulatory update on SPN-830
10 October 2022 - Supernus Pharmaceuticals today announced that the US FDA has issued a complete response letter for the SPN-830 ...
Posted by Michael Wonder on 07 Oct 2022
Hugel resubmits BLA for its botulinum toxin, Botulax to the US FDA
7 October 2022 - Hugel received CRL from the US FDA last March and completely supplemented documents and data. ...
Posted by Michael Wonder on 06 Oct 2022
US FDA accepts Takeda’s supplemental biologics license application for use of Takzyro (lanadelumab-flyo) to prevent hereditary angioedema attacks in children 2 years of age and older
5 October 2022 - Filing is based on data from Phase 3 SPRING study in paediatric patients 2 to <12 years ...