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RSS FeedPosted by Michael Wonder on 14 Feb 2023
NATCO files generic olaparib tablets in US
13 February 2023 - NATCO Pharma announces submission of abbreviated new drug application containing a paragraph IV certification with the ...
Posted by Michael Wonder on 14 Feb 2023
FDA grants 15 June 2023 PDUFA date to Albireo for Bylvay in Alagille syndrome
14 February 2023 - ASSERT study demonstrated efficacy of Bylvay in pruritus, bile acids and sleep with a low drug-related diarrhoea ...
Posted by Michael Wonder on 14 Feb 2023
Mirum Pharmaceuticals submits supplemental new drug application to FDA for Livmarli in patients with cholestatic pruritus in progressive familial intrahepatic cholestasis
14 February 2023 - Submission based on MARCH Phase 3 study with high statistical significance (p<0.0001) between LIVMARLI versus placebo, and ...
Posted by Michael Wonder on 14 Feb 2023
Soligenix receives refusal to file letter from US FDA for HyBryte new drug application in the treatment of cutaneous T-Cell lymphoma
14 February 2023 - Soligenix intends to seek guidance from the FDA on how to further advance HyBryte towards potential ...
Posted by Michael Wonder on 13 Feb 2023
Ocuphire announces FDA acceptance of new drug application and PDUFA date of 28 September 2023 for Nyxol eye drops for reversal of mydriasis
13 February 2023 - If approved later this year, Nyxol could be the only commercially available eye drop for reversal of ...
Posted by Michael Wonder on 13 Feb 2023
US FDA issues a CRL for the biologics license application for bevacizumab
12 February 2023 - The US FDA has issued a complete response letter for the biologics license application for bevacizumab ...
Posted by Michael Wonder on 13 Feb 2023
Ironwood Pharmaceuticals announces FDA filing acceptance and priority review of supplemental new drug application for Linzess (linaclotide) for functional constipation in children and adolescents ages 6-17 years old
13 February 2023 - FDA assigns second quarter 2023 target action date. ...
Posted by Michael Wonder on 10 Feb 2023
FDA approves Pfizer's supplemental new drug application for Cibinqo (abrocitinib)
10 February 2023 - Label expansion for Cibinqo provides new systemic oral option for adolescents (12 to <18 years) with ...
Posted by Michael Wonder on 08 Feb 2023
Appili Therapeutics announces that FDA accepts the ATI-1501 NDA
8 February 2023 - ATI-1501, liquid oral reformulation of the antibiotic metronidazole, receives PDUFA action date of 23 September 2023. ...
Posted by Michael Wonder on 07 Feb 2023
Aldeyra Therapeutics announces FDA acceptance of new drug application for reproxalap for the treatment of dry eye disease
7 February 2023 - PDUFA date is 23 November 2023. ...
Posted by Michael Wonder on 06 Feb 2023
Sage Therapeutics and Biogen announce FDA accepts filing of new drug application and grants priority review of zuranolone in the treatment of major depressive disorder and post-partum depression
6 February 2023 - Zuranolone is being evaluated as a potential 14 day, rapid acting, once daily, oral medication to treat ...
Posted by Michael Wonder on 06 Feb 2023
Sandoz biologics license application for proposed biosimilar denosumab accepted by US FDA
6 February 2023 - Submission supported by comprehensive analytical and clinical data package. ...
Posted by Michael Wonder on 01 Feb 2023
Mesoblast resubmits biologic license application to FDA for remestemcel-L in children with steroid-refractory acute graft versus host disease
31 January 2023 - New 4 year data from the Phase 3 trial shows durable long term survival outcomes. ...
Posted by Michael Wonder on 30 Jan 2023
Abbisko Therapeutics announces that US FDA has granted breakthrough therapy designation for its CSF-1R inhibitor pimicotinib (ABSK021)
30 January 2023 - Abbisko Therapeutics today announced that its CSF-1R inhibitor pimicotinib (ABSK021) has been granted breakthrough therapy designation ...
Posted by Michael Wonder on 30 Jan 2023
argenx receives notification of PDUFA date extension for SC efgartigimod
27 January 2023 - argenx today announced that the US FDA has extended the review of the biologics license application ...