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

Ibrutinib is a kinase inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL), small ...

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

Mumbai: Global pharma major Lupin Limited has received approval from the United States Food and Drug Administration (USFDA) ...

Zydus Lifesciences receives tentative USFDA approval for its generic Ibrutinib tablets, used to treat various blood cancers.

Pharmaceutical company Lupin has received approval from the US Food and Drug Administration (USFDA) to market generic diabetes drugs.

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.

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

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

The US health regulator has pulled up Glenmark Pharmaceuticals for manufacturing lapses, including failure to establish laboratory controls, at its Pithampur-based plant.      In a warning letter, the ...

A warning letter is a serious communication from the USFDA that signifies a potential risk to public health or safety due to ...