Food and Drug Administration (FDA)
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The FDA issued Provention a CRL that focuses on a single low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging study in health volunteers.
FDA greenlit Jazz Rylaze for use as a component of a chemotherapy regimen for the treatment of ALL or lymphoblastic lymphoma in pediatric and adult patients.
After the July 4 holiday, the U.S. FDA has several things on their immediate calendar, including a couple target action dates and an advisory committee hearing. Here’s a look.
It’s a busy news day for COVID-19-related stories. Read on for more.
Christina Smolke said the financing will enable the company to use its synthetic biology platform to support essential medications that rely on plant-based materials.
Life sciences news sometimes flies under the radar. So here’s a look at a few stories you may have missed.
Orphazyme said that its OLE trial, which has been running for the past 24 months, showed that arimoclomol could be an effective and safe option in treating Niemann-Pick disease type C.
If approved, lenacapavir would be offered to HIV patients who have been heavily treated for the disease and have multi-drug-resistant HIV.
The U.S. FDA granted Fast Track Designation to three biopharma companies for the treatment of LGMD, episodic bleeding and leukemia.
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