Sun Pharmaceutical receives USFDA approval for oral JAK inhibitor ‘Leqselvi’
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
The product is bioequivalent and therapeutically equivalent to the reference listed drug
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India
The inspections concluded with no Form 483 observations or significant critical findings
Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension
Contepo offers a unique mechanism of action and has the potential to address increasing antibiotic resistance and gaps in the current antibiotic treatment landscape
dsm-firmenich decided to de-prioritize certain business segments, including the MEG-3 business
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
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