Business Wire1d
FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug ...
BioPharma Dive5d
Troy Tazbaz, an FDA digital health leader, resigns
Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading on policies involving artificial ...
Healio7d
Decentralized clinical trials: FDA guidance and the ‘new modus operandi’
The COVID-19 pandemic forced investigators conducting clinical trials to use decentralized elements, such as telehealth, to ...
Rolling Out8d
Why the FDA says menthol cigarettes must go now
The Food and Drug Administration has ignited a heated debate with its latest review of menthol cigarettes, revealing ...
Medscape4d
Role of FDA's Drug Information Centers
The primary distinction is that neither of FDA's DICs provides medical advice that deviates from FDA-approved prescribing information. As a result, these DICs do not necessarily conduct extensive ...
Avant Technologies to Play Key Role in Ainnova's U.S. FDA Clinical Study for Its Vision AI Platform
Avant Technologies, Inc. (OTCQB: AVAI) ("Avant" or the "Company"), and its partner, Ainnova Tech, Inc., (Ainnova), a leading healthcare technology company focused on revolutionizing early disease ...
Health Affairs9d
The Lingering Legacy Of Thimerosal
While evidence-based decisions are essential, they must be paired with effective public messaging that builds trust and ...
JD Supra7d
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
Business Insider10d
EQS-News: Avant Technologies to Play Key Role in Ainnova's U.S. FDA Clinical Study for Its Vision AI Platform
Avant Technologies to Play Key Role in Ainnova's U.S. FDA Clinical Study for Its Vision AI Platform 27.01.2025 / 14:04 CET/CEST The issuer is solely responsible for the content of this announcement.
JD Supra6d
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
Trump administration withdraws FDA plan to ban menthol cigarettes
The Food and Drug Administration had in April 2022 proposed to ban the sale of menthol cigarettes and flavored cigars, but ...