All articles by sayeeda nasreen
FDA approves Analog and Dipharma’s ANDA for nitisinone capsules
Nitisinone capsules are generic equivalent of Swedish Orphan Biovitrum’s Orfadin.
FDA accepts Bristol Myers Squibb’s repotrectinib NDA for review
The NDA included data from the first-in-human, open-label, global, multi-centre TRIDENT-1 trial.
Amplo Biotechnology receives NIH-NIAMS grant for gene therapy AMP-201
AMP-201 is designed to address the severe congenital myasthenic syndrome caused by collagen Q deficiency.
FivepHusion collaborates with Treehill, Syneos for Deflexifol
Deflexifol is developed for the co-administration of the chemotherapeutic agent 5-fluorouracil and its biomodulator leucovorin.
Novavax receives positive opinion from CHMP for full MA of Covid vaccine
NVX-CoV2373 is developed by making copies of the surface spike protein of SARS-CoV-2 that causes Covid.
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BSM supplies key component of Krystal Biotech’s DEB gene therapy
Patients with DEB have extremely fragile skin that blisters and tears with minor trauma or friction such as scratching or rubbing.
Daiichi Sankyo receives Japan’s MHLW approval for VANFLYTA
VANFLYTA was first approved as a monotherapy in the relapsed/refractory setting.
FDA grants priority review for Takeda and HUTCHMED’s fruquintinib NDA
The NDA included data from the Phase III FRESCO-2 and FRESCO trials.