Regulatory
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.
Stem cell therapy has been available for decades, but the medical field hasn’t fully used its treatment for all applications. In fact, the U.S. FDA has been warning people about using some stem cell therapies and deemed them illegal while others have strict restrictions on their use.
Shares of Heron Therapeutics climbs after it announced the U.S. FDA approved its non-opioid drug for extended pain relief following some surgeries.
Emergent company executives Fuad El-ibri and Robert Kramer will be testifying before a congressional probe after a botched batch of 15 million doses of J&J’s COVID-19 vaccine.
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