A total of 378 novel drugs and 27 biosimilars approved by the U.S. Food and Drug Administration (FDA) between 2010 and 2019 were evaluated according to approval numbers by year, therapeutic areas, modalities, route of administration,…

A drug dissolution profile is one of the most critical dosage form characteristics with immediate and controlled drug release. Comparing the dissolution profiles of different pharmaceutical products plays a key role before starting the…

The year 2020 was an eventful year for the pharmaceutical industry, with several companies across the world working at a feverish pace to find a treatment or a vaccine for the raging Covid-19, which has so far taken over 1.79 million lives…

SAN DIEGO--(BUSINESS WIRE) -- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today highlighted the company’s role in the manufacturing of Veklury® (remdesivir), Gilead Sciences’ antiviral drug for the treatment of patients with COVID-19…

In its continuous endeavor to bolster the competitiveness of the generics market, the US Food and Drug Administration (FDA) updated its list of ‘off-patent, off-exclusivity drugs without an approved generic’. The agency updates this list…

In case you thought Covid-19 had slowed down the speed at which generic active pharmaceutical ingredient (API) manufacturers were submitting Drug Master Files (DMFs) to the US Food and Drug Administration (FDA), you are in for a pleasant…

Today, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex was previously…

Ubrelvy™ December 2019 and Koselugro™ April 2020 are the most recent FDA approval of drug using Vitamin E TPGS in the formulation. TPGS properties: Emulsifier - solubilizer of poorly soluble drugs - absorption enhancer - PgP inhibitor -…

Statement from Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D. at March 05, 2020 Over the past year, the U.S. Food and Drug Administration has embarked on a comprehensive evaluation of cannabidiol…

The United States Pharmacopeia (USP) appreciates the opportunity to provide comments on a potential FDA novel excipient review program. USP is supportive of a novel excipient review program. Establishing new pathways for the development and…