Accro will retain global rights to develop, manufacture, and commercialize AC-201 (excluding Chinese Mainland, Hong Kong SAR, and Macau SAR)
As with any medicine, the MHRA will keep the safety of gepotidacin under close review
Triggering global regulatory submissions this year for the treatment of obesity
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
With the addition of Phase II (~91 KL) in Q1 FY26, the combined capacity of the block now stands at ~200 KL
Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients
The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia
New manufacturing facility in Mebane to produce at least 40 million laboratory pipette tips per week
This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
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