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

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 ...

The U.S. Food and Drug Administration may reportedly fast-track new drugs from pharmaceutical companies that “equalize” the ...

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

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 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 ...

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

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