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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 ...

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

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.

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 ...

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.

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

Even though the Pharmexcil doesn't expect delay in the certification timelines, Joshi said that problem is with the ...