Food and Drug Administration (FDA)
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Shares of Assertio Therapeutics plunged more than 28% Monday after the company announced the U.S. Food and Drug Administration rejected an injectable formulation of long-acting cosyntropin.
The U.S. Food and Drug Administration approved a new cystic fibrosis medication that is expected to provide treatment for 90% of patients with this debilitating and life-shortening condition.
The decision was based on new analysis run by Biogen in consultation with the FDA of a larger dataset from the trials halted in March.
The approval is based on the Phase III UNIFI study that showed that after eight weeks of taking a single intravenous dose of Stelara, patients saw “clinical remission in a significantly greater proportion of UC patients.”
Thanks to a new regulatory win, AstraZeneca’s Farxiga can now be used to reduce the risk of hospitalization for heart failure in type 2 diabetes patients with cardiovascular disease and with certain risk factors.
Genentech’s flu medication Xofluza won a new indication for the treatment of acute, uncomplicated influenza in people 12 years of age and older who have been symptomatic for less than 48 hours and are at high risk of flu-related complications.
SGM-101 is an investigational new imaging agent for fluorescence-guided surgery designed to enable surgeons to better visualize tumor tissues in real-time
ADC Therapeutics SA announced that the first patients have been dosed in a 100-patient pivotal Phase 2 clinical trial evaluating the efficacy and safety of ADCT-301 in patients with relapsed or refractory Hodgkin lymphoma The trial is intended to support the submission of a Biologics License Application to the U.S. Food and Drug Administration.
Minoryx Therapeutics announces that its lead drug candidate, leriglitazone (MIN-102), has been granted Orphan Drug Designation in Friedreich’s Ataxia by the US Food and Drug Administration (FDA).
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