Camargo

NOVEMBER 11, 2020

announced a collaboration to develop a companion diagnostic for Vitrakvi® (larotrectinib) NTRK (neurotrophic tropomyosin receptor kinase) inhibitor, approved in the U.S. In October, less than 18 months later, the FDA approved the companion test, which will allow physicians to better identify target eligible patients.

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FDA Law Blog

FEBRUARY 26, 2024

FDA borrowed this definition from 21 C.F.R. 314.3 , codified in 2016, which defines strength as the “ total quantity of drug substance in mass or units of activity in a dosage unit or container closure” and/or “the concentration of the drug substance.” mg/mL) for liquid parenteral drug products.

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The Pharma Data

DECEMBER 28, 2020

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. However, not all forward-looking statements contain these words.

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Delveinsight

FEBRUARY 5, 2021

Fortunately, there exists FDA-approved therapies and drugs that double the success rates of quitting. Smoking Cessation: What are the drugs available in the market? Some of these approved products contain nicotine as an active ingredient, while others do not. Generics in the Market.

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