Briefs: Aurobindo Pharma and Lupin
USFDA completes PAI of Lupin’s biotech facility in Pune
USFDA completes PAI of Lupin’s biotech facility in Pune
Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy
Clariant is launching high-performing pharmaceutical ingredients to support the evolution of safe and effective medicines
This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated
Gilead Sciences first launched Lenacapavir under the brand name Sunlenca in the United States and Europe markets in the year 2022
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype
These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity
Roche’s CINtec PLUS Cytology is the only FDA-approved and CE-marked dual-stain test to triage human papillomavirus (HPV)-positive cervical cancer screening test results
Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations
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