The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
The inspections concluded with no Form 483 observations or significant critical findings
Contepo offers a unique mechanism of action and has the potential to address increasing antibiotic resistance and gaps in the current antibiotic treatment landscape
Phase III ARANOTE trial met primary endpoint, significantly increasing radiological progression-free survival (rPFS) with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT
Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024)
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
Lupin can receive a potential total consideration of up to USD 84 million based on future contingent milestones
Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension
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