The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions. The authors, in a series of articles, clarify the intent and criticality ...
WEST SACRAMENTO, Calif., March 13, 2025 /PRNewswire/ — Gemini Bioproducts, LLC (“GeminiBio”), a biopharma and advanced therapy raw materials supplier, and a portfolio company of BelHealth Investment ...
NEWARK, Del.--(BUSINESS WIRE)--ANP Technologies, Inc. (ANP) announced that its drug master file (DMF) on its novel, nano-encapsulating polymer-based drug excipient, ANP001B has been accepted and ...
BUFFALO, N.Y., Jan. 23, 2023 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a leading biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis and ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
The European Commission (EC) approved Almirall’s oral dimethyl fumarate (DMF) drug Skilarence ® as first-line induction and maintenance therapy for adults with moderate-to-severe plaque psoriasis. The ...
The metabolite of a drug that is helping patients battle multiple sclerosis appears to significantly slow the onset of Parkinson's disease, researchers say. The oral drug, dimethylfumarate, or DMF, ...
The pharmaceutical industry is constantly evolving, and the need for quality medicines has never been greater. PM Modi’s clarion call to ‘reform, perform & transform,’ couldn’t have been more ...
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