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RSS FeedPosted by Michael Wonder on 08 Dec 2021
Fortress Biotech, Cyprium Therapeutics and Sentynl Therapeutics announce the initiation of rolling submission of a new drug application for CUTX-101, copper histidinate, for treatment of Menkes disease
7 December 2021 - Cyprium Therapeutics with support from its licensing partner Sentynl Therapeutics today announced the initiation of a ...
Posted by Michael Wonder on 07 Dec 2021
Spectrum Pharmaceuticals submits new drug application for poziotinib
6 December 2021 - Fast track application is based on positive data in NSCLC HER2 exon 20 insertion mutations in previously ...
Posted by Michael Wonder on 06 Dec 2021
Theratechnologies submits supplemental biologics license application to FDA advancing development of IV push Trogarzo for patients living with HIV
6 December 2021 - sBLA submission with FDA follows on the back of recently announced positive TMB-302 study results. ...
Posted by Michael Wonder on 04 Dec 2021
U.S. Food and Drug Administration accepts for priority review supplemental biologics license application for Reblozyl (luspatercept-aamt) in adults with non-transfusion dependent beta thalassaemia
3 December 2021 - Submission based on results from Phase 2 BEYOND study of Reblozyl plus best supportive care in ...
Posted by Michael Wonder on 02 Dec 2021
CytoDyn submits CMC (manufacturing) section of HIV BLA to FDA under previously authorised rolling review; last (clinical) section will complete full BLA submission
1 December 2021 - FDA may initiate review of this biologics license application under previous rolling review granted to CytoDyn. ...
Posted by Michael Wonder on 01 Dec 2021
BioXcel Therapeutics announces extension of FDA review period of its NDA for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders
1 December 2021 - PDUFA date extended by three months to 5 April 2022. ...
Posted by Michael Wonder on 01 Dec 2021
Zogenix announces U.S. FDA acceptance for priority review of supplemental new drug application for Fintepla (fenfluramine) for the treatment of seizures associated with Lennox-Gastaut syndrome
1 December 2021 - Prescription Drug User Fee Act target action date of 25 March 2022. ...
Posted by Michael Wonder on 01 Dec 2021
U.S. FDA accepts for priority review the supplemental biologics license application for Merck’s Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for use in infants and children
1 December 2021 - Merck today announced the U.S. FDA has accepted for priority review a supplemental biologics license application for ...
Posted by Michael Wonder on 01 Dec 2021
CTI BioPharma announces extension of FDA review period for pacritinib in myelofibrosis with severe thrombocytopenia
30 November 2021 - CTI BioPharma today announced the U.S. FDA has extended the review period for the new drug application ...
Posted by Michael Wonder on 30 Nov 2021
Lynparza granted priority review in the US for BRCA mutated HER2 negative high risk early breast cancer
30 November 2021 - First medicine targeting BRCA mutations to show clinical benefit in adjuvant setting. ...
Posted by Michael Wonder on 29 Nov 2021
Bristol Myers Squibb’s applications for deucravacitinib for the treatment of moderate to severe plaque psoriasis accepted by U.S. Food and Drug Administration and validated by European Medicines Agency
29 November 2021 - Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy ...
Posted by Michael Wonder on 29 Nov 2021
Fennec Pharmaceuticals expects to receive complete response letter from the FDA for its new drug application for Pedmark to prevent ototoxicity associated with cisplatin in paediatric patients with localised, non-metastatic solid tumours
29 November 2021 - FDA pre-approval inspection identified deficiencies with the facility of the drug product manufacturer, which require resolution prior ...
Posted by Michael Wonder on 23 Nov 2021
Amryt provides update on regulatory review process for Oleogel-S10
23 November 2021 - FDA PDUFA goal date extended by three months to 28 February 2022. ...
Posted by Michael Wonder on 22 Nov 2021
Gilead submits biologics license application to U.S. Food and Drug Administration for bulevirtide, an investigational treatment for people living with chronic hepatitis delta
19 November 2021 - If approved, bulevirtide will be the first treatment option for adult patients in the U. S. with ...
Posted by Michael Wonder on 22 Nov 2021
Intarcia Therapeutics takes one last shot at FDA approval
22 November 2021 - Its diabetes treatment twice rejected, the company is in the midst of a rarely used appeal process, ...