Without holding a meeting of its vaccines advisory committee, the U.S. Food and Drug Administration (FDA) authorized a fourth shot of the Pfizer-BioNTech and Moderna COVID-19 vaccines for everyone 50 years of age and older.
The U.S. Food and Drug Administration held a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee on Avenue Therapeutics’ IV tramadol.
A panel of expert advisers to the U.S. Food and Drug Administration on November 30 narrowly voted to recommend the regulatory agency authorize Merck & Co.’s antiviral pill to treat Covid-19.
The FDA’s outside expert panel will meet on November 30, 2021, to deliberate Merck’s pill for Covid-19 infection.
A panel of expert advisers to the U.S. Food and Drug Administration unanimously voted on Oct. 14 to recommend booster shots of Moderna Inc.’s Covid-19 vaccine for Americans aged 65 and older and those at high risk of severe illness or occupational exposure to the virus.
Scientists at the U.S. Food and Drug Administration said on Oct. 12 that Moderna Inc. had not met all of the regulatory agency’s criteria to support use of booster doses of the company’s Covid-19 vaccine, possibly because the efficacy of the shot’s first two doses has remained strong.
The U.S. Food and Drug Administration Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend use of Takeda Pharmaceutical Company Limited’s maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease withgenotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients.
Advisers to the U.S. Food and Drug Administration voted on Sept. 17 to recommend Covid-19 vaccine booster shots for Americans 65 and older and those at high risk of severe illness, after overwhelmingly rejecting a call for broader approval.
A U.S. Food and Drug Administration committee gave the nod to continue using Genentech’s checkpoint inhibitor Tecentriq in combination with chemotherapy to treat adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1.
A U.S. health advisory panel on April 14 is set to review six reported cases of rare blood clots in women who received Johnson & Johnson’s Covid-19 vaccine one day after federal regulators paused the use of the shot to assess the issue.