Alvotech rated Hold after FDA setback for AVT05. Click for my look at ALVO stock prospects and what would make me upgrade it ...
FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...
Shares of Alvotech slid after the Food and Drug Administration sent a complete response letter saying the company would have to resolve certain deficiencies before it could receive approval for its ...
Shares of Alvotech (NASDAQ: ALVO) fell 22% on Monday after the U.S. Food and Drug Administration (FDA) issued a Complete ...
Total GAAP operating expenses of $115.3 million for the third quarter 2025 increased by 8% as compared to $106.6 million for the third quarter 2024. Total non-GAAP operating expenses 2 were up 15% to ...
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FDA’s ‘surprising’ uniQure reversal drags down Biohaven
Shares of BioHaven (BHVN) are sliding on Monday after uniQure (QURE) announced that the Food and Drug Administration no longer agrees AMT-130 data ...
Predictive analytics and integrated safety systems shift fleets from reactive responses to proactive risk management. Fleet safety’s digital evolution is driving a powerful transformation in ...
Reports record revenue of $21.2 million for the third quarter of 2025, an increase of $2.9 million, or 16%, compared to the same period in ...
Investing.com -- Alvotech (NASDAQ:ALVO) stock tumbled 22% after the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) for the company’s biosimilar candidate to Simponi.
Vinay Prasad, chief of the FDA’s Center for Biologics Evaluation and Research, is planning to publish a paper this month to outline his office’s thinking of accelerating gene editing reviews.
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