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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 ...
The company also holds the non-US commercial rights to Regeneron’s evinacumab-dgnb, which is approved by the FDA and EMA. [6] The company also has therapies approved outside the U.S. in Canada, Latin America, Europe, and Japan. [7] In 2020 and 2021, Ultragenyx was named one of Deloitte's fasting growing technology and life sciences companies ...
Cefiderocol may cause serious and life-threatening allergic reactions, severe diarrhea caused by C. difficile and seizures. [9]An increased rate of mortality was observed in people treated with cefiderocol as compared to other antibiotics in a separate clinical trial in critically ill people with multidrug-resistant Gram-negative bacterial infections.
The approval of Appili's drug could help ease the metronidazole shortage in the U.S., especially for patients in hospitalized settings and those with severe i Canada's Appili gets US FDA approval ...
This listing is limited to those independent companies and subsidiaries notable enough to have their own articles in Wikipedia. Both going concerns and defunct firms are included, as well as firms that were part of the pharmaceutical industry at some time in their existence, provided they were engaged in the production of human (as opposed to veterinary) therapeutics.
Sacituzumab govitecan was approved for medical use in the United States in April 2020, [12] [13] [15] and in the European Union in November 2021. [10] The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) consider it to be a first-in-class medication. [16] [17]
The company produces and sells a variety of medicines, with 1,400 approved therapeutic molecules in its portfolio. [30] It owns brands (like Viagra , Xanax , Lipitor ), [ 6 ] [ 31 ] generics , including branded and complex generics, biosimilars , [ 32 ] [ 33 ] and over-the-counter (OTC) drugs and active pharmaceutical ingredients .
The U.S. Food and Drug Administration on Thursday sent letters to nine companies including e-commerce retailer Chewy warning them against selling the products that it said contained antibiotics ...