Blog
RSS FeedPosted by Michael Wonder on 05 Mar 2024
Zevra Therapeutics provides FDA update on the PDUFA action date for arimoclomol as a treatment for Niemann-Pick disease type C
4 March 2024 - The new PDUFA action date set by the FDA is 21 September 2024. ...
Posted by Michael Wonder on 04 Mar 2024
SpringWorks Therapeutics initiates rolling submission of new drug application to the FDA for mirdametinib for the treatment of children and adults with NF1-PN
4 March 2024 - SpringWorks Therapeutics announced today that the Company has initiated a rolling submission of a new drug application ...
Posted by Michael Wonder on 04 Mar 2024
Hugel receives US FDA approval for its botulinum toxin Letybo
3 March 2024 - Hugel becomes the first and only Korean company that have market approvals in all three major aesthetic ...
Posted by Michael Wonder on 01 Mar 2024
FDA approves amivantamab-vmjw for EGFR exon 20 insertion mutated non-small cell lung cancer indications
1 March 2024 - Today, the FDA approved amivantamab-vmjw (Rybrevant, Janssen) with carboplatin and pemetrexed for the first-line treatment of ...
Posted by Michael Wonder on 01 Mar 2024
Intercept announces FDA acceptance of supplemental new drug application for Ocaliva (obeticholic acid) for the treatment of PBC
29 February 2024 - FDA has assigned a PDUFA target action date of 15 October 2024. ...
Posted by Michael Wonder on 28 Feb 2024
Applied Therapeutics announces FDA acceptance and priority review of new drug application for govorestat for the treatment of classic galactosaemia
28 February 2024 - PDUFA target action date of 28 August 2024. ...
Posted by Michael Wonder on 28 Feb 2024
Incyte announces US FDA grants priority review for axatilimab for the treatment of chronic graft versus host disease
27 February 2024 - Priority review acceptance based on positive results of AGAVE-201 study. ...
Posted by Michael Wonder on 28 Feb 2024
The FDA isn’t afraid to yank a disappointing drug
26 February 2024 - The FDA is rescinding its approval of a blood cancer treatment from the Swedish firm Oncopeptides, ...
Posted by Michael Wonder on 28 Feb 2024
FDA grants fast track designation to 9MW2821
27 February 2024 - Mabwell announces that its self developed novel antibody drug conjugate targeting Nectin-4 (9MW2821) has been granted fast ...
Posted by Michael Wonder on 27 Feb 2024
Nuvalent receives US FDA breakthrough therapy designation for NVL-520
27 February 2024 - Nuvalent today announced that the US FDA has granted breakthrough therapy designation to NVL-520 for the ...
Posted by Michael Wonder on 27 Feb 2024
Theratechnologies receives refusal to file letter for Trogarzo intramuscular method of administration sBLA from FDA
27 February 2024 - Theratechnologies today announced that the US FDA has issued a refusal to file letter regarding the Company’s ...
Posted by Michael Wonder on 27 Feb 2024
BeiGene’s biologics license application for Tevimbra (tislelizumab) for first-line gastric or gastro-oesophageal junction cancers accepted by FDA
27 February 2024 - Application based on results from global Phase 3 RATIONALE-305 trial demonstrating Tevimbra plus chemotherapy significantly improved overall ...
Posted by Michael Wonder on 27 Feb 2024
Minerva Neurosciences receives complete response letter from FDA for new drug application for roluperidone for the treatment of negative symptoms in patients with schizophrenia
27 February 2024 - Minerva Neurosciences announced today that the US FDA has issued a complete response letter to the ...
Posted by Michael Wonder on 27 Feb 2024
US FDA accepts for priority review the supplemental biologics license application for epcoritamab (Epkinly) for difficult to treat relapsed or refractory follicular lymphoma
26 February 2024 - FDA grants priority review with target action date of 28 June 2024. ...
Posted by Michael Wonder on 26 Feb 2024
Bayer receives US FDA breakthrough therapy designation for BAY 2927088 for non-small-cell lung cancer harbouring HER2 activating mutations
26 February 2024 - BAY 2927088 is an oral, small molecule tyrosine kinase inhibitor under development as a potential new targeted ...