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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 ...

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

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 US FDA has approved Purespring Therapeutics’ IND application for PS-002, allowing the company to begin a Phase I/II trial.

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

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

Shares of Instil Bio jumped after federal regulators cleared the investigational new drug application for its tumor treatment AXN-2510. The stock was up 11% at $24.38 in early trading. Shares were ...