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.
The U.S. Food and Drug Administration decided to put together an advisory committee meeting of outside experts to review a New Drug Application (NDA) for FibroGen and partner AstraZeneca’s investigational anemia therapy roxadustat.
The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices voted to recommend the use of Moderna Inc.’s Covid-19 vaccine on people 18 years of age and older.
U.S. coronavirus deaths soared to a daily record of 3,580 and hospitalizations rose for the 19th straight day on Dec. 16, ramping up the stakes as regulators on Dec. 17 considered whether to approve a second Covid-19 vaccine.