Regulatory
Neffy 1 mg is the “first significant innovation” for epinephrine delivery in small children aged 4 years and up in over 35 years, according to ARS Pharmaceuticals.
The Senate hearing for FDA Commissioner nominee Marty Makary comes after President Trump’s NIH pick, Jay Bhattacharya, was grilled by the legislative body on Wednesday.
The vaccine space has been battered by strong headwinds in recent weeks, including high-level disruptions to FDA and CDC advisory committee meetings.
The last few years have been tough for the insulin market, with recent policies and high-level pressure forcing companies to lower drug prices.
TNKase is the first stroke drug to win FDA approval in nearly three decades.
Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that will apply to all EU member states as well as Norway, Liechtenstein and Iceland.
Two recent documents—one from the FDA, the other from a commission organized by The Lancet Diabetes & Endocrinology—indicate an evolving mindset toward treating obesity as a chronic disease.
In the five weeks since Donald Trump returned as U.S. president, the FDA, NIH and CDC have been thrown into disarray, with meetings regarding vaccines and rare diseases canceled or indefinitely postponed—all without a clear reason why.
The company will push through with an accelerated approval application for odronextamab in follicular lymphoma, leaving diffuse large B cell lymphoma behind.
The back-to-back high-level disruptions in vaccine policy under Robert F. Kennedy Jr. comes as the U.S. records its first death from measles since 2015.
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