Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track ...

The verdict can be an ‘approved’ decision ... as the timeline by which a decision will be given. If the FDA does not mention any timeline, the company may roughly calculate a timeline based ...

Stereotaxis' holistic ecosystem approach aims to solve long-standing issues with robotic adoption in EP. See why STXS stock ...

Pharmaceutical consultants accelerate the drug development process by applying deep expertise in therapeutic areas.

The FDA also used accelerated approval for the initial clearance of asciminib in 2021 for use in CML previously treated with ...

This is due to the multi-year process, which can lead to multiple opportunities for litigation that may delay timelines set ...

The FDA approved new COVID-19 vaccines from Pfizer ... Each drug manufacturer during a June meeting with the FDA gave different timelines for when their respective vaccines will be ready.

Elanco is an animal health company that develops products for pets and farm animals, including Zenrelia, an oral Janus kinase inhibitor for canine dermatology, and Credelio Quattro, a parasiticide for ...

Following the U.S. Food and Drug Administration extending the review period for the company's New Drug Application (NDA) for ...