FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission
If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease
If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease
All pending litigation between Biocon Biologics, Regeneron, and Bayer will be dismissed
DBT and BIRAC have partnered with CEPI since 2019, for cooperation on vaccine development for diseases of epidemic potential
This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA
Medroxyprogesterone acetate-SC is a three-month contraceptive that can be administered by healthcare workers or self-injected after appropriate training
The FDA is beginning rulemaking to close the “adequate provision” loophole
Fermenta now becomes one of the only two companies globally to hold a CEP for this variant of Vitamin D3
Milestone also announced the extension of its $75 million Royalty Purchase Agreement with RTW Investments
The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act
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