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RSS FeedPosted by Michael Wonder on 15 Mar 2021
Calliditas announces submission of new drug application to U.S. FDA for Nefecon in patients with primary IgA nephropathy
15 March 2021 - Calliditas Therapeutics today announced the submission of a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 13 Mar 2021
Marius Pharmaceuticals receives PDUFA date for Kyzatrex NDA for treatment of hypogonadism
11 March 2021 - Marius Pharmaceuticals announced today that the U.S. FDA has assigned a Prescription Drug User Fee Act goal ...
Posted by Michael Wonder on 11 Mar 2021
Kadmon announces U.S. FDA has extended the review period for belumosudil in chronic graft versus host disease
10 March 2021 - Kadmon today announced that the U.S. FDA has extended the review period for the new drug application ...
Posted by Michael Wonder on 10 Mar 2021
FDA accepts the new drug application for review of Idorsia’s daridorexant for the treatment of adult patients with insomnia
10 March 2021 - The application includes robust data from the Phase 3 registration program, which demonstrated efficacy of daridorexant on ...
Posted by Michael Wonder on 10 Mar 2021
U.S. FDA accepts UVision360 submission for novel Luminelle DTx system biopsy sheath
9 March 2021 - UVision360 announces today that the U.S. FDA has accepted the Company's submission to expand the Luminelle DTx ...
Posted by Michael Wonder on 09 Mar 2021
Acadia Pharmaceuticals provides regulatory update on supplemental new drug application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis
8 March 2021 - Acadia Pharmaceuticals today announced that the Company received a notification from the U.S. FDA on 3 March ...
Posted by Michael Wonder on 08 Mar 2021
Cara Therapeutics and Vifor Pharma announce U.S. FDA acceptance and priority review of NDA for Korsuva injection in haemodialysis patients with moderate to severe pruritus
8 March 2021 - FDA has set Prescription Drug User Fee Act target action date of 23 August 2021. ...
Posted by Michael Wonder on 04 Mar 2021
Junshi Biosciences and Coherus BioSciences announce initiation of rolling submission of BLA for toripalimab to the U.S. FDA for the treatment of nasopharyngeal carcinoma
3 March 2021 - BLA submitted with FDA’s breakthrough therapy designation. ...
Posted by Michael Wonder on 04 Mar 2021
FDA accepts Dupixent (dupilumab) for review in children with moderate to severe asthma
4 March 2021 - Submission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to ...
Posted by Michael Wonder on 03 Mar 2021
Strongbridge Biopharma announces submission of new drug application for Recorlev (levoketoconazole) for the treatment of endogenous Cushing’s syndrome to the U.S. FDA
2 March 2021 - Recorlev (levoketoconazole) new drug application is supported by previously reported positive and statistically significant results from the ...
Posted by Michael Wonder on 03 Mar 2021
On Target Laboratories announces U.S. FDA acceptance and priority review of new drug application for pafolacianine sodium injection for identification of ovarian cancer during surgery
3 March 2021 - On Target Laboratories today announced that the U.S. FDA has accepted its new drug application for priority ...
Posted by Michael Wonder on 03 Mar 2021
Oyster Point Pharma announces FDA acceptance for filing new drug application for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease
2 March 2021 - Prescription Drug User Fee Act target action date is 17 October 2021. ...
Posted by Michael Wonder on 02 Mar 2021
Eyenovia announces FDA acceptance of the MydCombi new drug application
2 March 2021 - Eyenovia today announced that the U.S. FDA has accepted the Company’s new drug application for MydCombi, ...
Posted by Michael Wonder on 02 Mar 2021
GC Pharma submits biologics license application to US FDA for immune globulin 'GC5107'
25 February 2021 - Submission for entering the world’s largest US marketplace. ...
Posted by Michael Wonder on 01 Mar 2021
Agios submits supplemental new drug application to FDA for Tibsovo (ivosidenib) for patients with previously treated IDH1 mutant cholangiocarcinoma
1 March 2021 - Agios Pharmaceuticals today announced that it has submitted a Supplemental new drug application to the U.S. FDA ...