London: GSK plc has announced the extension of the US Food and Drug Administration (FDA) review period for the Biologics ...

The Carbamazepine extended-release tablets are indicated for use as an anti-convulsant drug and also for the treatment of the ...

Zydus Lifesciences got USFDA approval for Celecoxib capsules (50–400 mg) to treat arthritis, JIA, and AS. Made in Ahmedabad, ...

Zydus Lifesciences Ltd on Thursday said it has received tentative approval from the US health regulatory agency for its generic version of cancer treatment drug Ibrutinib tablets.

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration ...

Biocon Biologics receives USFDA approval for Kirsty, an interchangeable biosimilar to NovoLog, expanding their insulin ...

Aurobindo Pharma has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Clopidogrel Tablets USP 75mg, which is being launched.Clopidogrel Tablets USP ...

The company is going to announce results for the quarter ended June 30th, 2025 on July 23, 2025 after the board meeting.

Ibrutinib tablets had annual sales of $2,148.9 million in the United States, as per the IQVIA data dated May 2025, Zydus Life ...

Lupin receives USFDA approval for generic Liraglutide Injection and Glucagon, expanding access to diabetes treatments.

The US diabetes market presents a substantial opportunity for Biocon Biologics, with 38.4 million people living with diabetes ...

A Form 483 is issued at the conclusion of an inspection when USFDA investigators observe conditions that may be in violation ...