The Janssen Pharmaceutical Companies of Johnson & Johnson submitted a Biologics License Application (BLA) for teclistamab to the U.S. Food and Drug Administration for relapsed or refractory multiple myeloma.
The U.S. Food and Drug Administration placed a clinical hold on Gilead Sciences’ use of injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV and HIV pre-exposure prophylaxis (PrEP).
The U.S. Food and Drug Administration on December 3 authorized the use of Eli Lilly’s Covid-19 dual-antibody therapy in treating mild to moderate symptoms in all children, including newborns, who are at risk of severe illness.
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 U.S. Food and Drug Administration approved Covid-19 vaccine booster shots for all Americans ages 18 and over Friday morning.
Gilead Sciences Inc. announced the submission of a Biologics License Application to the U.S. Food and Drug Administration for bulevirtide for injection (2 mg), a potential first-in-class antiviral medicine for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease; bulevirtide has been granted Breakthrough Therapy and Orphan Drug designations by the FDA.
Iterum Therapeutics will head back into the clinic to meet regulatory requirements to refile a New Drug Application for oral sulopenem, which has been developed to treat uncomplicated urinary tract infections.
Philips, the medical equipment maker that is recalling ventilators due to use of parts containing a potentially hazardous foam, said on November 14 the company is in discussions with U.S. regulators after a new inspection of one of its facilities.
Malvern, Pa.-based Ocugen submitted an Investigational New Drug Application to the U.S. Food and Drug Administration to run a Phase III trial of India’s Covid-19 vaccine BBV152 (Covaxin).
The FDA’s outside expert panel will meet on November 30, 2021, to deliberate Merck’s pill for Covid-19 infection.
