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RSS FeedPosted by Michael Wonder on 15 Dec 2021
Sapience Therapeutics receives FDA fast track designation for ST101 for advanced cutaneous melanoma
15 December 2021 - Sapience Therapeutics announced today that the U.S. FDA has granted fast track designation to its lead program, ...
Posted by Michael Wonder on 15 Dec 2021
U.S. FDA grants priority review for spesolimab for the treatment of flares in patients with generalised pustular psoriasis, a rare, life-threatening skin disease
15 December 2021 - Additionally, FDA granted breakthrough therapy designation for spesolimab in the treatment of generalised pustular psoriasis flares. ...
Posted by Michael Wonder on 15 Dec 2021
Alnylam submits regulatory applications to the U.S. FDA and EMA to support label expansion for Oxlumo for the treatment of advanced primary hyperoxaluria type 1
14 December 2021 - Findings from the ILLUMINATE-C Phase 3 study showed substantial reductions in plasma oxalate in PH1 patients with ...
Posted by Michael Wonder on 15 Dec 2021
Incyte announces acceptance and priority review of sNDA for ruxolitinib cream (Opzelura) as a treatment for patients with vitiligo
14 December 2021 - Incyte today announced that the U.S. FDA has accepted for priority review the supplemental new drug application ...
Posted by Michael Wonder on 14 Dec 2021
TG Therapeutics announces FDA acceptance of biologics license application for ublituximab as a treatment for patients with relapsing forms of multiple sclerosis
14 December 2021 - Prescription Drug User Fee Act goal date of 28 September 2022. ...
Posted by Michael Wonder on 08 Dec 2021
Pfizer will submit full data on Covid treatment pill to the FDA in a few days, CEO says
8 December 2021 - Pfizer CEO Albert Bourla said he’s confident the full results from the clinical trials will show that ...
Posted 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 ...