Epitomee Medical Ltd submitted its application to the U.S. FDA for 510k regulatory clearance for its swallowable weight loss capsule. It joins a host of companies offering solutions to the global obesity crisis.
Reflecting the evolving scientific understanding of Alzheimer’s disease, the U.S. FDA revised its 2018 draft guidance on developing drugs to treat early Alzheimer’s.
Wegovy (semaglutide) has racked up another indication. The U.S. FDA approved the injectable for reducing risk of major adverse cardiovascular events such as death, heart attack or stroke and for long-term weight management. The approval expands the drug’s potential. The mighty glucagon-like peptide 1 receptor agonist from Novo Nordisk A/S was already approved for those age 12 and older who are obese and for some overweight adults with weight-related problems.
Watertown, Mass.-based Lyndra Therapeutics Inc. is seeking patent protection for gastric residence drug delivery systems with improved shelf lives through their inclusion of a metal core.
Roche AG debuted a new continuous glucose monitor (CGM) at the Advanced Technologies & Treatments for Diabetes conference in Florence, Italy, last week, but how appealing users will find it remains unclear – as is the market opportunity given the entrenched position of Abbott Laboratories and Dexcom Inc.
This year’s annual meeting of the International Medical Device Regulators Forum (IMDRF) revolves around regulatory reliance, a notion that approaches but does not quite stray into the realm of the mutual recognition agreement.
U.S. deputy attorney general Lisa Monaco recently outlined some new programs related to federal enforcement across the economy, including some novel elements related to artificial intelligence (AI).
A first-quarter 2024 launch for Alzheimer’s drug donanemab appears to be off the table as Eli Lilly and Co. disclosed a last-minute decision by the U.S. FDA to convene an advisory committee to review data from the phase III Trailblazer-ALZ 2 trial.
In what was more of a campaign speech accompanied by frequent chants of “four more years,” U.S. President Joe Biden loaded the annual State of the Union address March 7 with what sounded like campaign promises for a second term. Among those promises were calls to Congress to expand the prescription drug price provisions of the 2022 Inflation Reduction Act.
Several members of the U.S. Congress have inked legislation that provides taxpayer resources to help bring many types of manufacturing, including medical devices and equipment, back to the Western Hemisphere in general and, in some instances, the U.S.
RSS
