FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...

Alvotech rated Hold after FDA setback for AVT05. Click for my look at ALVO stock prospects and what would make me upgrade it ...

Shares of BioHaven (BHVN) are sliding on Monday after uniQure (QURE) announced that the Food and Drug Administration no longer agrees AMT-130 data ...

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 ...

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.

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.

As the first in the category to receive the SGS Cybersecurity Mark, Owlet provides a tangible solution for families who want ...

The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in ...

AI refers to a machine-based system and ML refers to a set of techniques that can be used to train AI algorithms (2) so ML ...

Somehow, the generation most skeptical about frozen food’s nutrition, quality, and safety is the one that's most been forced ...