Food and Drug Administration (FDA)
NEWS
Gilead’s Veklury made massive profits, but as more vaccine boosters arrive and more people become immune to the virus, the future of the antiviral is in question.
AbbVie is off to a strong start for 2022 driven by success from Skyrizi and Rinvoq, as well as the company’s neuroscience platform. Abbvie also won FDA approval for a new indication for Rinvoq.
The FDA approval was based on data from the Phase III Explorer-HCM trial that showed Bristol Myers Squibb’s Camzyos could decrease the heart’s contractility.
Finch Therapeutics has been given the green light to continue the Phase III Prism4 clinical trial, investigating the efficacy of CP101 in fighting recurrent C. difficile infections (CDI).
Eli Lilly had a lucrative first quarter, with revenue growth rising 15% driven by sales of its diabetes drug Trulicity and its COVID-19 antibodies.
Moderna has made the official request to the FDA to approve its COVID-19 for use in children ages 6 months to 5 years. Moderna also announced the location of its first non-U.S. mRNA manufacturing facility.
Pfizer says it will open the first U.S. sites in its Phase III study evaluating its investigational mini-dystrophin gene therapy in ambulatory patients with Duchenne muscular dystrophy (DMD).
Alexion shared the news that Ultomiris (ravulizumab-cwvz) has been approved by the FDA for commercialization, adding another indication for the precedent-setting drug.
AviadoBio is celebrating orphan drug designations from both the U.S. FDA and the European Commission for AVB-101, a gene therapy intended to treat frontotemporal dementia (FTD).
JOBS
IN THE PRESS