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The U.S. Food and Drug Administration (FDA) approved the CAPVAXIVE™ vaccine to protect adults from bacteria that can cause pneumonia and invasive pneumococcal disease […]
FDA approves Merck’s vaccine against pneumococcus bacteria Read More »
On June 7, the U.S. Food and Drug Administration (FDA) approved an expanded age indication for GSK’s Arexvy, making it the first respiratory syncytial
FDA approves Arexvy for patients 50–59 Read More »
Biopharma supply chains, streamlining regulation, and other critical issues came up when the leader of the U.S. agency regulating drugs spoke with the leader
FDA’s Dr. Califf talks supply chains, clinical trial diversity, and America’s health Read More »
Several federal agencies on May 8 announced a plan to coordinate and streamline regulation of plants, animals, and microorganisms modified through biotechnology. The plan
EPA, FDA, and USDA release plan to improve biotech regulation Read More »
Dec. 8 was a historic day for the sickle cell community and CRISPR technology, as the U.S. Food and Drug Administration (FDA) approved two
FDA approves CRISPR-based sickle cell treatment in historic decision Read More »
The Federal Trade Commission (FTC) challenge of more than 100 patent listings registered with the Food and Drug Administration, mostly for devices used to
On November 9, the U.S. Food and Drug Administration (FDA) approved the first-ever vaccine against the chikungunya virus, a mosquito-borne disease that can be
FDA approves first vaccine for chikungunya virus Read More »
The U.S. Food and Drug Administration (FDA) has approved TIBSOVO (ivosidenib) as a treatment for a rare blood cancer, the agency said in an
Rare blood cancer drug wins FDA approval Read More »
The U.S. Food and Drug Administration (FDA) has approved a therapy used for the treatment of late-onset Pompe disease (LOPD). The two-component therapy is
Amicus Therapeutics wins FDA approval for breakthrough late-onset Pompe therapy Read More »
The Biotechnology Innovation Organization (BIO) is surveying biotech companies about their interactions with the Food and Drug Administration (FDA), with the goal of improving
BIO surveying biotech firms on how to improve communications with the FDA Read More »
