Ascentage Pharma’s Phase III study of Olverembatinib cleared by FDA

The US FDA's clearance of the trial marks the first global registrational Phase III trial for olverembatinib in patients with CP-CML to be conducted.

Lupin launches Bromfenac Ophthalmic Solution, 0.075% in US

Bromfenac Ophthalmic Solution 0.075% (RLD BromSite) had estimated annual sales of USD 15 million in the U.S.

Zydus receives Tentative Approval from the USFDA for Dexamethasone Tablets USP, 1 mg

Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions

Qure.ai adds new FDA breakthrough device status for qSpot-TB

4 FDA clearances & 61 EU MDR CE tags achieved for AI in 18 months

Glenmark partners Pfizer to launch Abrocitinib in India

Developed by Pfizer, Abrocitinib has received marketing authorization from the Central Drugs Standard Control Organization (CDSCO) in India

Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours

Submission to be reviewed under FDA real-time oncology review and Project Orbis

Zydus receives USFDA’s final approval for Gabapentin Tablets, 300 mg and 600 mg

Gabapentin is indicated for the management of Postherpetic Neuraligia

Lupin receives tentative USFDA approval for Rivaroxaban Tablets USP

Lupin receives USFDA’s approval for Febuxostat Tablets

Febuxostat Tablets (RLD Uloric) had estimated annual sales of US$ 27 million in the U.S. (IQVIA MAT November 2023)

Zydus receives USFDA’s approvals for Pimavanserin Capsules, 34 mg and Pimavanserin Tablets,10 mg

Pimavanserin is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson disease psychosis