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The therapy, a recombinant version, was developed to address supply and manufacturing issues.
August 02, 2021
This is the first new approval for lupus in a decade.
The agent targets excessive daytime sleepiness.
Pharmacies will need to obtain pre-dispense authorization for clozapine.
July 29, 2021
The FDA is requesting an additional study to demonstrate tenapanor lowers serum phosphorus.
The approval allows for substitution at the pharmacy counter for Lantus, its reference product.
July 26, 2021
The FDA would like to see additional data on clinical benefit for patients with anal cancer.
July 25, 2021
Current drug shortages based on FDA data, prepared by Formulary Watch.
Keytruda gets a full approval in endometrial cancer; while Xeljanz will miss another PDUFDA date.
July 21, 2021
The therapy is approved for both adults and children.
Azstarys is approved to treat patients 6 years and older.
