FDA clears a Stimwave 510(k) for the StimQ Peripheral Nerve Stimulator System, a wireless, micro-technology neuromodulation device for treating chroni...
Mylan CEO Heather Bresch blames FDA reorganization for delays in approvals for two new generic drugs.
FDA accepts for priority review a Genentech supplemental NDA for Zelboraf (vemurafenib) for Erdheim-Chester disease (ECD) with BRAF V600 mutation.
Federal Register notice: FDA makes available a draft guidance on CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Docume...
FDA releases for comment a draft guidance on CMC Post-approval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Repo...
Federal Register notice: FDA seeks comments on an information collection for Providing Waiver-Related Materials in Accordance With the Guidance for In...
A National Cancer Institute study identifies genes that may play a role in facilitating tumor destruction.
The Pew Charitable Trusts says it will launch an information-sharing digital platform in hopes of spurring discovery of innovative new antibiotics.