Drug Approval | July 11, 2025
FDA accepts new drug application for Merck’s Doravirine/Islatravir
The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act
The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act
The submission is based on data from the STEP UP and STEP UP T2D clinical trials
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
UFlex is the first and only Indian company to receive USFDA approval for its technology and capacity to recycle all three materials
If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference
The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance
This strategic move positions Sudeep Pharma to seamlessly integrate high-end premix capabilities with its mineral portfolio
Haloperidol Decanoate Injection indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy
This recertification of Company's OECD GLP is testimony to company's unwavering commitment to maintain international quality standards at the facility
The closing of the Block Acquisition is now expected to be completed by Q3 2025
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