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In May, the Food and Drug Administration approved as many as 13 new drugs, higher than the eight approved in the same month last year.
FDA approves expanded labels of Merck (MRK), Novartis (NVS) and Glaxo (GSK) drugs and Lilly's (LLY) new insulin. Pharma Stock Roundup: FDA Approvals to MRK, LLY, NVS and GSK's Drugs Skip to main ...
In the stock market, sometimes all it takes is a single catalyst to propel shares to sky-high levels. This is especially common with healthcare stocks. While they carry significant risk, these ...
The company has one drug on the market, Belviq (), a weight-loss medication.The U.S. Food and Drug Administration (FDA) approved lorcaserin on June 27, 2012. The company committed to a sales force commitment of 200. [11]
AstraZeneca (AZN) halts coronavirus vaccine study. FDA approves Roche (RHHBY) and Glaxo's (GSK) medicines.
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form.
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
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