Government
Novartis’ Entresto is well on its way to receiving approval as a treatment for heart failure patients following overwhelming support from a U.S. Food and Drug Administration (FDA) advisory committee.
Novartis’ Iptacopan isn’t the only drug to receive Breakthrough Therapy designation this week. Several other experimental treatments were also awarded the designation.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 15, 2020.
As the year wraps up, there are still some PDUFA dates on the agency’s calendar. Read on for this week’s.
If the U.S. Food and Drug Administration does not grant Emergency Use Authorization to the COVID-19 vaccine developed by Pfizer and BioNTech, the White House will demand the resignation of FDA Commissioner Stephen Hahn.
Hope for Pneumococcal Pneumonia Patients as FDA Grants Priority Review of Pfizer’s Vaccine Candidate
Pfizer is one step closer to receiving approval for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate after the Food and Drug Administration (FDA) on Wednesday granted priority review of a Biologics License Application (BLA) for the invasive disease and pneumonia vaccine.
Although vaccines will be available pending approval, there are questions as to how many people will quickly receive the vaccine and when more will be available.
President Donald Trump signed an Executive Order on Tuesday that ensures the U.S. government prioritizes delivery of COVID-19 vaccines to American citizens before sending it to other nations.
The document prepared and released by FDA staff indicates scientists from the agency plan to tell the advisory committee on Thursday that the available clinical trial data are adequate to support its safe and effective use in public immunization programs.
President Trump has repeatedly assured U.S. citizens his administration would secure enough COVID-19 vaccine doses to protect the nation. However, a new report shows his government failed to act in securing additional doses of Pfizer and BioNTech’s vaccine this summer.
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