Regulatory
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.
Sanofi’s troubles stemming from the 2019 recall of Zantac appear to be far from over.
Please check out the biopharma industry’s COVID-19 stories that are trending for May 11, 2021.
May is a busy month for the U.S. Food and Drug Administration (FDA)’s calendar for new drug reviews. Here’s a look.
The U.S. FDA approved Keytruda combined with Genentech’s Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
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