Food and Drug Administration (FDA)
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Fennec is looking for a second chance to approve PEDMARK, its pediatric chemotherapy-induced hearing loss prevention drug, as it resubmits its NDA for the agent to the U.S. FDA.
Bristol Myers Squibb has been busy the last two weeks with a string of approvals, positive clinical trial updates and deals. Here’s a look.
Determined to take its next-generation engineered cell therapies to the next level, BlueRock teams up with Senti Biosciences with futuristic medicines in mind.
The EUA was granted base on interim data from the Phase III COMET-ICE trial in high-risk adult outpatients.
The U.S. FDA has granted approval to MYFEMBREE, Myovant Sciences, and Pfizer’s once-daily treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Drug companies have been suggesting that booster shots will be needed. However, it is up to the CDC’s recommendation if booster shots are necessary.
Lilly said it is cooperating fully with the DOJ and is in the process of conducting its own investigation into the allegations made against the company.
This is the second IND to come out of the two companies’ collaboration. They will initiate a Phase I trial of the drug in cardiometabolic diseases.
When the pandemic hit, many companies diverted resources aimed at HIV to COVID-19, which ended up pausing some research efforts.
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