FDA approval of neffy, a nasal spray formulation of epinephrine, clears the way for ARS Pharma to launch the product in time for the new school year. In other recent regulatory news, the FDA approved updated Covid-19 vaccines as well as a new mpox vaccine. The post Highly Anticipated FDA Decision Comes Just in Time…
Nektar Therapeutics’ biologic drug rezpegaldesleukin take a new approach to atopic dermatitis, or eczema, stimulating proliferation of immune cells that tamp down excessive immune responses. The drug met the goals of a Phase 2b study, but analysts note that cross-trial measures show those results are short of the marks achieved by Dupixent, the top biologic…
Shortly after 1,000 Indian Health Service workers were let go, the layoffs affecting them were rescinded
McKesson is paying $2.49 billion in cash for a controlling interest in Florida Cancer Specialists’ management services organization
Digital health funding remains strong so far this year, with $9.9 billion raised through Q3 and megarounds driving record deal sizes. However, the path to scale is becoming less predictable, as startups increasingly rely on unlabeled rounds and face longer timelines to reach Series B. The post Inside a Big Q3: Venture Capital for Digital…
Sleep.ai’s $5.5 million in funding was led by Treasure Coast Ventures and included participation from Nurture Ventures, the Harvard Business School Alumni Angels of Greater New York and Supermoon Capital. The post Sleep.ai Secures $5.5M to Scale Sleep Intelligence Platform appeared first on MedCity News.
We know from everyday purchasing of goods and services that you have to combine what you’re getting with what you’re paying for that good or service. But how does this basic consumer supplier concept play out in US healthcare? The post VBC, MA, FHIR and Modern Care appeared first on MedCity News.
Generic drugs don’t need lengthy clinical trials to support a submission seeking FDA approval. The regulator now proposes ending this testing requirement for biosimilars, products that reference complex biologic medicines. The post FDA Proposes Dropping Clinical Trial Requirements to Bring Biosimilars to Market More Quickly appeared first on MedCity News.
As health and human services secretary, Robert F. Kennedy Jr. wields one of the louder megaphones the federal government has. Yet he insists he doesn’t want to impose his opinions on Americans. “I don’t think people should be taking medical advice from me,” Kennedy told a Democratic congressman in May. Kennedy once expressed different views…
By LEONARD D’ AVOLIO The murder of UnitedHealthcare CEO Brian Thompson has drawn attention to Americans’ frustration with the for profit healthcare insurance industry. Change is possible but less likely if people don’t understand how we got here, the real issues, and how they might be fixed. Health insurance wasn’t always run by big for…