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RSS FeedPosted by Michael Wonder on 05 Mar 2024
Formosa Pharmaceuticals and AimMax Therapeutics receive FDA approval for clobetasol propionate 0.05% ophthalmic suspension for the treatment of post-operative inflammation and pain following ocular surgery
4 March 2024 - Formosa Pharmaceuticals and AimMax Therapeutics announced today that the US FDA has approved clobetasol propionate 0.05% ...
Posted by Michael Wonder on 05 Mar 2024
Ellipses' next generation selective RET inhibitor EP0031/A400 granted fast track designation by US FDA
5 March 2024 - Ellipses Pharma announced today that it has received fast track designation from the US FDA for its ...
Posted by Michael Wonder on 05 Mar 2024
Sandoz receives FDA approval for first and only denosumab biosimilars
5 March 2024 - Wyost (denosumab-bddz) and Jubbonti (denosumab-bddz) interchangeable with and approved by FDA for all indications of reference ...
Posted 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 29 Feb 2024
Indapta Therapeutics receives US FDA fast track designation for lead clinical drug candidate IDP-023 for non-Hodgkin’s lymphoma and myeloma
29 February 2024 - Highly differentiated allogeneic natural killer cell therapy in Phase 1 trial, with initial data expected in second ...
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 ...