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RSS FeedPosted 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 09 Feb 2023
EMA confirms acceptance of application for AVT04, a proposed biosimilar to Stelara (ustekinumab)
9 February 2023 - EMA opinion on AVT04 could come as soon as the second half of 2023. ...
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 08 Feb 2023
Bayer submits aflibercept 8 mg for regulatory approval in two major retinal eye diseases in the EU
6 February 2023 - Filing for aflibercept 8 mg in neovascular (wet) age-related macular degeneration and diabetic macular oedema is based ...
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 03 Feb 2023
Zai Lab announces NDA for sulbactam-durlobactam granted priority review by China’s NMPA
30 January 2023 - Zai Lab today announced that the Center for Drug Evaluation of China’s National Medical Products Administration has ...
Posted by Michael Wonder on 03 Feb 2023
Enhanced MSAC application now available for March 2023 deadline
3 February 2023 - The enhanced MSAC application forms are now available in the health products portal for use by ...
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
Alpha Biopharma submits new drug application for zorifertinib, a next generation EGFR-TKI to treat EGFR mutated NSCLC patients with CNS metastases
30 January 2023 - Alpha Biopharma announces that the Center for Drug Evaluation of the NMPA has accepted its new drug ...
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 ...
Posted by Michael Wonder on 30 Jan 2023
Lecanemab receives priority review status in Japan
29 January 2023 - Eisai and Biogen announced today that an application for manufacturing and marketing approval for lecanemab, an anti-amyloid-β ...