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October 15, 2021
The FDA has assigned a target action date of April 13, 2022, and plans to hold an advisory committee meeting.
October 14, 2021
The committee voted unanimously to support the booster given at least six months after the second dose in the original vaccine.
This is the first anti-PD-1 combination approved for patients with persistent, recurrent or metastatic cervical cancer.
Hikma, which makes the broad-spectrum antibiotic, has experienced manufacturing delays.
October 13, 2021
The FDA has approved Tavneos, a first-in-class, oral therapy to treat a group of autoimmune diseases characterized by inflammation and damage to small blood vessels.
Verzenio is the first and only CDK4/6 inhibitor approved for this patient population.
Rethmyic is a one-time regenerative tissue-based therapy for children born without a thymus gland.
October 12, 2021
The company has received a PDUFA action date of March 11, 2022, for Adlarity, a transdermal patch for the treatment of Alzheimer’s disease.
October 11, 2021
Genentech is conducting phase 3 trials of gantenerumab, an anti-amyloid antibody.
Molnupiravir reduced the risk of hospitalization or death by about 50%.
