Regulatory
Loncastuximab tesirine-lpyl just got accelerated approval from the U.S. Food and Drug Administration (FDA). This is a systemic therapy for people with diffuse large B-cell lymphoma (DLBCL).
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.
LION-101 is a novel recombinant AAV being developed as a one-time intravenous infusion for the treatment of adult and adolescent patients with Limb-Girdle Muscular Dystrophy Type 2I/R9.
The White House has also called for an independent investigation and more information from China about the pandemic’s origins.
It’s a busy week for the U.S. Food and Drug Administration, with a number of drug approvals on the calendar and an advisory committee meeting. Read on for more information.
Several biopharmaceutical companies have submitted NDAs to the U.S. FDA covering treatment indications ranging from an opioid overdose, bipolar disorder and rare disease.
X-Vax Technology is ready to submit an IND application to the U.S. FDA for its experimental herpes vaccine against HSV-1 and -2. Here’s what you need to know.
The U.S. FDA scolded CytoDyn for misrepresenting its clinical trial results for Leronlimab in COVID-19. Here’s what FDA has to say regarding CytoDyn Leronlimab.
Please check out the biopharma industry’s COVID-19 stories that are trending for May 18, 2021.
The guidance takes effect immediately and will remain in effect throughout the pandemic.
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