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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.

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

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

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.

Johnson & Johnson (NYSE:JNJ) submitted a supplemental New Drug Application for CAPLYTA®, aiming to prevent schizophrenia ...

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

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

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 ...

- NDA assigned a Target Action Date of February 25, 2026 - ...

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune‑mediated and metabolic diseases ...

Ideally, the approval of a new drug should be exclusively the province of science, but for a more than half-trillion-dollar-a-year industry, it couldn't possibly remain so. The same libertarian ...