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2. Fast track (FDA) - Wikipedia

   en.wikipedia.org/wiki/Fast_track_(FDA)

   Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. Fast track designation must be requested by the drug company.

3. List of drugs granted breakthrough therapy designation

   en.wikipedia.org/wiki/List_of_drugs_granted...

   In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...

4. Formulary (pharmacy) - Wikipedia

   en.wikipedia.org/wiki/Formulary_(pharmacy)

   In the US, where a system of quasi-private healthcare is in place, a formulary is a list of prescription drugs available to enrollees, and a tiered formulary provides financial incentives for patients to select lower-cost drugs. For example, under a 3-tier formulary, the first tier typically includes generic drugs with the lowest cost sharing ...

5. List of therapeutic monoclonal antibodies - Wikipedia

   en.wikipedia.org/wiki/List_of_therapeutic...

   This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.

6. Lexicon Pharmaceuticals IBS Drug Gets on FDA Fast Track - AOL

   www.aol.com/news/2012-12-18-lexicon...

   Biotech Lexicon Pharmaceuticals announced Monday that the Food and Drug Administration has given "fast track" status to Lexicon's LX1033 drug to treat diarrhea-predominant irritable bowel syndrome ...

7. Investigational New Drug - Wikipedia

   en.wikipedia.org/wiki/Investigational_new_drug

   The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.

8. Approved Drug Products with Therapeutic Equivalence ...

   en.wikipedia.org/wiki/Approved_Drug_Products...

   inducing pioneering research and development of new drugs and; enabling competitors to bring low-cost, generic copies of those drugs to market'". [1] The Orange Book identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.

9. US FDA says Lilly’s weight-loss drug shortage is resolved

   www.aol.com/news/us-fda-says-lilly-weight...

   The U.S. Food and Drug Administration said on Thursday there was no longer a shortage of Eli Lilly’s (LLY.N) blockbuster weight loss and diabetes drugs following a re-evaluation of their supply ...