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
BAV has revolutionized the animal vaccination industry with its ground-breaking delivery methods that prioritize quality, safety, and efficacy
Performed an autologous bone marrow transplant, using the patient’s own cells to reduce the chances of infection and rejection
The acquisition will further strengthen Barentz’ position in India creating a leading life science distribution platform
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
This strategic move aims to make Cupid's high-quality products more accessible to consumers nationwide
Acquisition in line with Mankind’s stated objective to expand its presence in high entry barrier complex portfolios and high potential OTX brands
EBITDA grew by 31% YoY with EBITDA margin of 11%, a YoY improvement of over 170bps vs. Q1FY24
Shilpa Biologicals has developed high concentration adalimumab (100 mg/mL)
The inspections concluded with no Form 483 observations or significant critical findings
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