Drug Approval | September 04, 2025
Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity
This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity
This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity
Enlicitide achieved all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol
The new subcutaneous autoinjector for lecanemab offers a self-administered, at-home treatment option for early-stage Alzheimer's disease
Zilebesiran, a potential best-in-disease RNAi anti-hypertensive with twice-yearly subcutaneous dosing, demonstrated encouraging safety when combined with two or more antihypertensives
The positive benefit-risk profile of vericiguat in its approved indication in patients with HFrEF following a recent heart failure event based on the pivotal Phase III VICTORIA trial remains unchanged
As with any medicine, the MHRA will keep the safety of gepotidacin under close review
Treatment with Verzenio also resulted in sustained invasive disease-free survival and distant relapse-free survival benefit
WIDAPLIK is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals
Triggering global regulatory submissions this year for the treatment of obesity
With the addition of Phase II (~91 KL) in Q1 FY26, the combined capacity of the block now stands at ~200 KL
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