BioPharma Dive4d
With Trump victorious, biotech industry’s focus turns to his plans for FDA, FTC
The president-elect has said he’ll let Robert F. Kennedy Jr. “go wild” on healthcare, while many expect a leadership change ...
pharmaphorum3d
FDA reveals diversity action plan guide for clinical trials
what information should be included in the plan, ways to request a waiver, and when and how it should be submitted to the FDA. For example, a DAP must be prepared for pivotal trials of a new drug ...
Yahoo Finance24d
FDA prioritizes guidance on lab developed tests in 2025 plan
To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. The Food and Drug Administration released a list of the medical device guidance documents it plans to work ...
It’s time to shop for Medicare, and 2025 brings big changes
A bumper crop of revisions, including a stronger drug benefit, means the Medicare plan you enrolled in for 2024 may not be ...
Investopedia7y
Orphan Drug Status: What it Means, How it Works, Example
From this realization, the Orphan Drug Act of 1983 was born. The plan was to target diseases ... Developing new drugs is a risky business—especially if a company fails to receive a patent.
FierceBiotech26d
FDA puts Novavax's phase 3 plan for pair of vaccine programs on hold over nerve disease case
Novavax’s plans for growth outside of its COVID program have been thrown into chaos after the FDA put two of the ... s plans to boost the value of the business are grounded “not only [in ...
Money Talks News on MSN11d
4 States Where Medicare Drug Plan Premiums Are Less Than $5 a Month
If you are looking for lower Medicare drug plan costs, it helps to live in the right state. In some places, Medicare Advantage drug plan premiums cost less than $5 a month, according to an analysis by ...
Food Safety News21d
FDA warns foreign seafood importers about serious HACCP violations
Business owners have 15 days to ... a bacterium that produces life-threatening toxins. The FDA recommended that Bacalao Giraldo revise its HACCP plan to address these deficiencies, warning that ...
The Business Journals27d
Nanoscope Therapeutics to seek FDA approval for lead product
Learn more about the business and the treatment ... Feedback from the FDA has informed Nanoscope's BLA submission plan, said Dr. Allen Ho, director of retina research and co-director of the ...
NBC New York12d
Novo Nordisk's Ozempic and Wegovy now available in the U.S. after shortages, FDA says
All doses of Novo Nordisk's weight loss injection Wegovy and diabetes drug Ozempic are now available in the U.S., according to an update on the FDA's drug shortage database. It is a sign that Novo ...
Business Wire1mon
Advicenne achieves major milestones in the US thanks to several positive FDA opinions on ADV7103
PARIS--(BUSINESS WIRE)--Regulatory News ... of major milestones in the development program of its ADV7103 drug in the U.S, and the search for commercial partners. ADV7103 in dRTA (Distal Renal ...
Los Angeles Times15d
Skipping Medicare drug coverage now can mean paying more later when you do sign up
Dear Liz: I did not enroll in Part D prescription coverage when I enrolled in Medicare in 2005 because I was not taking any prescriptions at the time. When I enrolled a few years later, I was ...