The Food and Drug Administration has lifted in-person dispensing requirements for mifepristone when used for medical termination of early pregnancy. In an April 12, 2021, letter to the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine,…
Read More
U.S. FDA Expands Approval of Pfizer’s Lorbrena as First-Line Treatment for ALK-Positive Metastatic Lung Cancer
NEW YORK–(BUSINESS WIRE) March 03, 2021 — The U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s (NYSE: PFE) supplemental New Drug Application (sNDA) for Lorbrena® (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase…
Read More
FDA clears Johnson & Johnson COVID-19 vaccine for emergency use
The U.S. Food and Drug Administration (FDA) authorized Johnson & Johnson’s COVID-19 vaccine for emergency use on Saturday (Feb. 27), making it the third shot cleared for use in the country. “The authorization of this vaccine expands the availability of…
Read More
Johnson & Johnson COVID-19 vaccine headed for FDA committee vote: What the experts say
Johnson & Johnson vaccine on track for final approval in coming days The single-dose vaccine is a ‘big addition’ the COVID-19 vaccine arsenal, Fox News medical contributor Dr. Marc Siegel says. A U.S. Food and Drug Administration advisory committee on…
Read More
FDA says single-dose shot from J&J prevents severe COVID
Johnson & Johnson’s single-dose vaccine offers strong protection against severe COVID-19, according to an analysis released Wednesday by U.S. regulators that sets the stage for a final decision on a new and easier-to-use shot to help tame the pandemic. The…
Read More
Still no evidence of COVID-19 transmission from food, FDA says
There is “no credible evidence” that SARS-CoV-2, the virus that causes COVID-19, is transmitted through contaminated food or food packaging, according to a statement just released by the U.S. Food and Drug Administration (FDA). The statement follows a news conference…
Read More
FDA Approves Libtayo (cemiplimab-rwlc) as First Immunotherapy Indicated for Patients with Advanced Basal Cell Carcinoma
TARRYTOWN, N.Y. and PARIS, Feb. 9, 2021 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) as the first immunotherapy treatment indicated for patients with…
Read More
FDA Approves Ukoniq
FDA Approves Ukoniq (umbralisib) for Marginal Zone Lymphoma and Follicular Lymphoma NEW YORK, Feb. 05, 2021 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the U.S. Food and Drug Administration (FDA) has approved Ukoniq™ (umbralisib), for the treatment…
Read More
FDA to weigh half-dosing Moderna COVID-19 vaccines: Operation Warp Speed official
Fox News Flash top headlines for January 4 Fox News Flash top headlines are here. Check out what’s clicking on Foxnews.com. The U.S. Food and Drug Administration is discussing a move to administer Moderna coronavirus vaccines in half-doses to distribute the…
Read More
FDA Approves Pediatric Indication for Xeomin (incobotulinumtoxina) for the Treatment of Chronic Sialorrhea
RALEIGH, N.C., December 21, 2020 — Merz Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA) for the treatment of patients aged 2 years and older with chronic…
Read More