Approvals
The FDA accepted Bayer’s supplemental New Drug Application for its proposed oral treatment for metastatic hormone-sensitive prostate cancer.
Orphalan announced the FDA has granted full approval to Cuvrior (trientine tetrahydrochloride) for the treatment of Wilson’s Disease, a rare genetic disorder.
Hutchmed failed to secure FDA approval for its proposed drug for pancreatic cancer. The company will have to go through another trial if they want U.S. approval.
Notably, Qelbree is the first novel FDA approval of a novel non-stimulant treatment for ADHD in adults in 20 years.
Shares of Praxis Precision Medicines are falling after the company announced the FDA has placed a clinical hold on the company’s IND Application for its experimental epilepsy drug, Prax-222.
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).
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.
In its 2022 Q1 earnings report, Sanofi reported major wins in the first quarter of 2022, driven mostly by the success of consumer healthcare (CHC) and Dupixent.
PRESS RELEASES