External advisors to the U.S. Food and Drug Administration will meet on Sept. 17 to consider data from Pfizer and BioNTech in support of booster shots. Meanwhile, a timeline is being presented on the authorization of Covid-19 vaccines for children.
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The U.S. Food and Drug Administration said on Sept. 16 it has revised the FDA’s emergency use authorization for Eli Lilly’s Covid-19 antibody cocktail to include for use in patients who have been exposed to the virus and are at high risk for progression to severe disease.
Biogen reported positive topline results from the company’s Phase II CONVEY trial of vixotrigine for the treatment of small fiber neuropathy (SFN).
Pfizer Inc. said on Sept. 16 the company was recalling all lots of the anti-smoking treatment Chantix due to high levels of cancer-causing agents called nitrosamines in the pills.
Data from Moderna Inc.’s large Covid-19 vaccine trial shows that the protection it offers wanes over time, supporting the case for booster doses, the company said in a news release on Sept. 15.
Several Asian nations are quickly ramping up vaccination campaigns from shaky starts to combat growing Covid-19 infections, as supply shipments roll in and people overcome hesitancy in hopes of easing curbs and freeing up travel.
Shares of Theravance Biopharma rapidly declined after the company announced a Phase III cardiac drug failed to meet the study’s primary endpoint and a significant shift in its R&D efforts that resulted in a 75 percent staff termination.
The U.S. Food and Drug Administration approved Takeda Pharmaceutical Company Limited’s Exkivity (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Imre has expanded the agency’s focus on earned activation with the addition of Bria Rooney as Vice President of Public Relations.
U.S. Food and Drug Administration scientists said on Sept. 15 that booster doses of Pfizer’s Covid-19 vaccine may not be needed, even though the third shot generates a higher immune response in recipients.