VIASKIN patch is designed to introduce microgram amounts of an allergen like peanuts to the immune system through intact skin ...

The FDA has approved intranasal etripamil (Cardamyst; Milestone Pharmaceuticals) for the acute treatment of paroxysmal supraventricular tachycardia (PSVT), making it the first self-administered, ...

Adagene (ADAG) stock and Palvella Therapeutics (PVLA) stock rise as the FDA issued Fast Track Designations for the companies' ...

Fast Track designation designed to facilitate the development, and expedite the review, of drugs to treat serious conditions ...

The FDA has proposed cutting fees for early-stage companies conducting clinical development in the U.S. instead of abroad. The proposal is designed to incentivize U.S. drug development by tacking on ...

Matthew Herper covers medical innovation — both its promise and its perils. Changes to the ways in which the Food and Drug Administration plans to regulate vaccines represent a threat to effective and ...

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...

In the Senate, every Republican, seven Democrats and one independent who caucuses with Democrats voted for the bill. In the House, all but two Republicans voted in favor alongside six Democrats who ...

Düsseldorf, Germany — German plastics recycler Wis Kunststoffe GmbH has received U.S. Food and Drug Administration (FDA) food-contact approval for its recycled polypropylene. The approval, granted at ...

The Food and Drug Administration (FDA) has put four companies on notice for marketing “unapproved fluoride-containing ingestible drugs” for use by children under the age of 3 or children at low or ...

Please provide your email address to receive an email when new articles are posted on . The FDA issued draft guidance that would streamline testing of biosimilars. A separate plan would eliminate ...

The FDA's draft guidance could streamline biosimilar approval by reducing the need for comparative efficacy studies, emphasizing analytical assessments instead. This approach may lower development ...