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The trial is scheduled to commence in the fourth quarter of this year, with subject recruitment in both Europe and the US.

By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often ...

Johnson & Johnson (JNJ) said on Tuesday that it has submitted a supplemental new drug application to the U.S. Food and Drug ...

The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

The Food and Drug Administration (FDA) has accepted the New Drug Application for doravirine/islatravir (DOR/ISL) for adults with virologically-suppressed HIV-1 infection.

Arcus Biosciences announced that the Food and Drug Administration has granted its pancreatic cancer treatment, quemliclustat, with an orphan drug designation. The company said it expects its ongoing ...

The FDA has accepted Aquestive Therapeutics’ new drug application for its Anaphylm sublingual epinephrine film for treating ...

The Bagsvaerd, Denmark, company said that if the application is approved, Wegovy would become the first oral formulation of a GLP-1 drug for chronic weight management.

– This submission is supported by the pivotal Phase 3 VERITAC-2 clinical trial, results of which were recently presented at the 2025 American Society for Clinical Oncology Annual Meeting and ...

A worrisome analysis of this issue was published in the New England Journal of Medicine by Erick Turner, MD, a psychiatrist who had spent several years at the FDA reviewing new drug applications.