2019 Clinical Pharmacology FDA Approval Therapies 
Drug Discovery World
SEPTEMBER 14, 2023
Patients with mUC, including FGFR-driven tumours, face a particularly poor prognosis and the need for innovative therapies remains high. N Engl J Med 2019; 381(4):338-348. Prognostic value and clinical significance of FGFR genomic alterations (GAs) in metastatic urothelial cancer patients. Expert Review of Clinical Pharmacology.
Metabolite Tales Blog
JULY 5, 2023
Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Balazs et al., Hammami et al.,
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Metabolite Tales Blog
JULY 5, 2023
Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Balazs et al., Hammami et al.,
Agency IQ
SEPTEMBER 15, 2023
Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. FDA’s cough cold monograph only designates two oral products as GRASE – phenylephrine and pseudoephedrine.
The Pharma Data
FEBRUARY 8, 2021
1 Quality of life was comparable between treatment arms per Functional Assessment of Cancer Therapy–Prostate (FACT-P Total). Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. percent of patients in the combination arm versus 56.2
Agency IQ
SEPTEMBER 29, 2023
The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.
Agency IQ
OCTOBER 27, 2023
The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.
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