Tag Archives: FDA

Treatments and best practices on when to prescribe hormone therapy and what medications to use have evolved in recent years. MStudioImages/E+/Getty Images hide caption toggle caption MStudioImages/E+/Getty Images When obstetrician JoAnn Pinkerton spoke on a Food and Drug Administration panel recently, she didn’t mince words. “Please stop harming women,” she said. Pinkerton argues that the FDA’s black box warning labels …

Jennifer Hill Blair recognized the Cincinnati number on her buzzing phone and slipped out of the school meeting, excited to finally learn when her son Cayse would receive a therapy she believed would change his life. Blair, a second-grade teacher in southern Mississippi, and her husband had been fighting the state insurer since April, calling senators and representatives to lobby …

Replimune’s shares crater as FDA rejects melanoma drug  Fierce Biotech Replimune skin cancer therapy rejected by FDA, a sign of regulators’ hardened stance  statnews.com Replimune drug rejected by FDA; Omega raises $647M biotech fund  Yahoo Finance Replimmune Plummets Following FDA’s Surprise Rejection of Melanoma Treatment  BioSpace Replimune Stock Plummets 75% After FDA Rejects Application for Skin Cancer Treatment  Barron’s Source link

Andrew Joseph covers health, medicine, and the biopharma industry in Europe. You can reach Andrew on Signal at drewqjoseph.45. The Food and Drug Administration on Monday named George Tidmarsh, a longtime biotech executive who has a background in oncology and pediatrics, as its top drug regulator. Tidmarsh, who will be the director for the FDA’s Center for Drug Evaluation and …

Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy  Fierce Biotech We are mothers of Duchenne patients. Recent setbacks with Sarepta must not stop progress  statnews.com Sarepta Therapeutics stock sinks after FDA tells company to stop shipping its bestselling drug  Yahoo Finance Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths  The New York Times …

WASHINGTON (AP) — The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency’s drug program, the latest in a string of leadership changes at the agency. FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s Center for Drug Evaluation and Research, which regulates the safety …

FILE PHOTO: The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Maryland November 4, 2009.  Jason Reed | Reuters The Food and Drug Administration said on Monday it has appointed former biotech executive George Tidmarsh as the agency’s top drug regulator. Tidmarsh, an adjunct professor of pediatrics and neonatology at Stanford University’s School of …

FDA to Appoint Biotech Executive as RFK Jr.’s Top Drug Regulator  Bloomberg.com FDA taps biotech veteran George Tidmarsh to lead drug center  statnews.com FDA to appoint former biotech executive Tidmarsh as top drug regulator, Bloomberg News reports  Yahoo Home George Tidmarsh named Director of Center for Drug Evaluation and Research: USFDA  Medical Dialogues FDA to Appoint George Tidmarsh as Top Drug Regulator, Bloomberg News …

Varieties of a popular deodorant brand are being recalled due to safety concerns. More than 67,000 cases of Power Stick products are being voluntarily recalled nationwide by manufacturer A.P. Deauville, according to People. The recall affects three specific Power Stick products: 21,265 cases of Power Stick for Her Roll-on Antiperspirant Deodorant Powder Fresh; 22,482 cases of Power Stick Invisible Protection …

Sarepta plans Elevidys shipments despite FDA request (SRPT)  Seeking Alpha Sarepta Refuses FDA Request to Stop Shipping Muscular Dystrophy Drug Elevidys  The New York Times FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold for Multiple Gene Therapy Products Following 3 Deaths  fda.gov We are mothers of Duchenne patients. Recent setbacks with Sarepta must not stop progress  statnews.com Sarepta …