News | April 11, 2021
NATCO receives approval for Ibrutinib tablets from ANDA
The approval is for Ibrutinib tablets 560 mg, 420 mg, 280 mg and 140 mg strengths
The approval is for Ibrutinib tablets 560 mg, 420 mg, 280 mg and 140 mg strengths
Zydus was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Ibrutinib Capsules, 70 mg.
The receipt of this permission paves way for the launch of Osimertinib 40mg/80mg film coated tablets in India.
The study enrolled 639 patients, nearly 80% of whom had previously received a covalent BTK inhibitor
The regulatory decision follows promising results from RIVER-81
Deal brings late-stage lung cancer candidates zidesamtinib and neladalkib into GSK’s portfolio
The trial results are for the pharma powerhouse's RET-targeted therapy Retevmo (selpercatinib)
While overall survival data remain immature, the results pointed to a favourable trend.
The aflibercept biosimilar, referencing Eylea, becomes the company’s fifth directly commercialized biosimilar in Europe, expanding access to ophthalmology treatments
The results confirm the study’s primary endpoint of objective response rate and now deliver a striking signal in progression-free survival
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