U.S. Food and Drug Administration
Diplomat, the country’s largest independent specialty pharmacy, announced it is one of five specialty pharmacies selected as a provider of Imbruvica (ibrutinib) capsules, approved Nov. 13 by the U.S. Food and Drug Administration for the treatment of mantle cell lymphoma.
Perrigo Co. (Nasdaq: PRGO) announced that it has filed with the U.S. Food and Drug Administration an Abbreviated New Drug Application for testosterone gel 1.62 percent and that it has notified AbbVie Inc., the owner of the Reference Listed Drug of its filing.
Technology-related industry awards, recognitions, prizes and certifications earned by Michigan’s technology-focused companies, institutions, groups and people
NSF International, an independent global public health and safety organization which develops standards as well as tests and certifies products for the food, water, health and consumer products industries, has acquired Becker & Associates Consulting Inc., a clinical, regulatory and scientific consulting firm that specializes in U.S. Food and Drug Administration-regulated industries, specifically medical devices, pharmaceuticals and biologics.
Perrigo Co. announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for butoconazole nitrate 2% vaginal cream, the generic equivalent of Gynazole·1.
Perrigo Co. Friday announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Lansoprazole capsules (15 mg). Shipments of product to customers have already begun.
A Detroit federal judge rules that a western Michigan farm illegally sold cows for human food with unacceptably high levels of antibiotics.
St. Joseph-based GeneGo this week announced the availability of ToxHunter, the first commercial release of tools and content developed through its industry-FDA MetaTox partnership program. ToxHunter is a unique comprehensive systems toxicology suite designed for […]