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FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews.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 ...
While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in ...
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 ...
Part one of a two-part series on FDA Commissioner Martin Makary, M.D.s comments at the Gailen Forum in New York City on October 30, 2025.
Regeneron posts Q3 earnings of $11.83 per share, topping estimates as Dupixent profits lift results despite weaker Eylea ...
Recursion, Roche and Genentech unveiled the latest product of their nearly four-year artificial intelligence drug discovery collaboration. GSK ’s Blenrep was approved by the FDA for treatment of ...
Chain restaurants in New York City must now display triangle symbols on menu items exceeding 50 grams of sugar, and experts ...
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 ...
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