The U.S. Food and Drug Administration lifted the clinical hold made by the regulatory agency during February 2021 for Spero Therapeutics’ Phase IIa trial of SPR720, an oral antimicrobial agent being studied in patients with nontuberculous mycobacterial pulmonary disease (NTM-PD).
BioSpace looks at the 10 biggest drug approvals of 2021, headlined by Biogen’s Aduhelm (aducanumab) for Alzheimer’s disease and Pfizer and BioNTech’s COVID-19 vaccine Comirnaty.
Interval between Moderna COVID-19 vaccine second shot and booster still six months – FDA January 3, 2022; 11:53 AM EST WASHINGTON, Jan 3 (Reuters) – The interval between receiving a […]
The U.S. Food and Drug Administration on January 3 authorized the use of a third dose of the Pfizer and BioNTech COVID-19 vaccine for children ages 12 to 15, and narrowed the interval for booster shot eligibility to five months from six.
The FDA granted Emergency Use Authorization (EUA) to Pfizer and BioNTech for their COVID-19 vaccine booster shots in kids ages 12 and up.
Shares of Applied Therapeutics plunged in premarket trading on January 3 after the company announced it is unable to seek regulatory approval of the Galactosemia therapeutic AT-007 at this time.
Novavax Inc. will submit a request to the U.S. Food and Drug Administration to authorize the company’s COVID-19 vaccine in January 2022, further delaying the submission it had expected by the end of 2021.
The U.S. Food and Drug Administration approved Xeris Biopharma Holdings Inc.’s Recorlev (levoketoconazole) for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.
BioSpace reviews the 10 biggest drug approvals of 2021, headlined by Biogen’s Aduhelm (aducanumab) as the first drug approved for Alzheimer’s disease in almost 20 years.
The U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) for Siemens Healthineers’ CLINITEST Rapid COVID-19 Antigen Self-Test, providing nationwide access to a new at-home or over-the-counter self-test as Covid-19 testing needs continue to grow for individuals, families and businesses.
