FDA releases a Form-483 from a February inspection at Dr. Reddys oncology drug formulation manufacturing facility in Duvvada, Visakhapatnam, India.
FDA approves a Genentech NDA for Ocrevus (ocrelizumab) for treating adult patients with relapsing forms of multiple sclerosis and primary progressive ...
Arizona approves the first state legislation to authorize truthful communication on off-label uses between drug and medical device companies and healt...
FDA commissioner nominee Scott Gottlieb says he will recuse himself for one year from decisions involving about 20 healthcare companies he has a finan...
FDA issues Mylan a complete response letter on its ANDA for a generic copy of GlaxoSmithKlines asthma therapy Advair Diskus (fluticasone propionate 10...
FDA clears a NuVasive 510(k) for the CoRoent Small Interbody System indicated for intervertebral body fusion at multiple contiguous levels in the cerv...
The Parker Institute for Cancer Immunotherapy, Bristol-Myers Squibb and the Cancer Research Institute announce a multi-year clinical research collabor...
FDA clears a Bodycad 510(k) for its Bodycad Unicompartmental Knee System, a joint reconstruction implant system.