Carbamazepine Tablets USP, 200 mg have an estimated market size of $32 million for 12 months ending December 2024, according ...

Alembic Pharmaceuticals (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Carbamazepine Tablets USP ...

The FDA laid out a three-year roadmap to phase out animal toxicity testing in drug research. In addition to organoids and lab ...

The FDA previously granted breakthrough therapy designation to ziftomenib for relapsed/refractory NPM1-mutant AML.

Alembic Pharmaceuticals announced that it has received final approval from the U.S. Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Carbamazepine Tablets USP, ...

From my colleague Allison DeAngelis: Over the last few years, the drug industry has rushed to retool CAR-T treatments for ...

In Actavis Labs. FL, Inc. v. U.S.  (“Actavis”), a recent precedential decision, the Federal Circuit answered an important ...

Treatments for COPD, psoriasis, and neuroendocrine tumors, as well as a next-generation COVID-19 vaccine are under review.

The FDA issued a complete response letter for the resubmission of the reproxalap new drug application for the treatment of ...

The initiative, which will start with monoclonal antibodies, is the first big regulatory shift from the FDA since Martin ...

Tenpoint Therapeutics submitted a new drug application to the FDA for Brimochol PF, an eye drop for presbyopia treatment, ...