FDA Approves New Drug to Slow Alzheimer’s Disease

July 6, 2023 – The FDA today approved a new therapy for early Alzheimer’s disease that appears to modestly slow the progression of the disease that affects more than  6.5 million Americans.   The drug, Leqembi, targets amyloid plaques in patients’ brains, a key feature of the disease. Study data shows it may slow Alzheimer’s …

FDA Warns of Tattoo Ink Tied to Dangerous Infections

June 16, 2023 – The FDA draft guidance released this week on possible contamination of tattoo ink was not concerning Whitney Donohue, 34, owner of Forget Me Not Tattoo in Billings, MT.  “I get our ink directly through the manufacturer – not at a store or through Amazon or eBay,” she said. “You never know …

FDA Panel Backs New COVID Booster Focusing Only on Variants

June 15, 2023 – A panel of advisers to the FDA unanimously agreed today that the next COVID-19 vaccines should target the XBB variants of the SARS-CoV-2 virus now in circulation in the United States, but questioned whether the population as a whole needs booster shots and how often they should be given. The Vaccines …

FDA Finalizes Limit on How Much Arsenic Can Be in Apple Juice

By Cara Murez  HealthDay Reporter WEDNESDAY, June 7, 2023 (HealthDay News) — Federal regulators have finalized new guidance on how much inorganic arsenic can be present in apple juice, in an effort to limit the exposure of infants and young children to this environmental contaminant. What is the new limit? 10 parts per billion, a …

FDA Commissioner Talks AI and Misinformation

May 31, 2023 – In an exclusive sit-down interview with WebMD’s John Whyte, MD, FDA Commissioner Robert M. Califf, MD, shares how artificial intelligence could transform the future of medicine, what the FDA can and cannot do about drug shortages and misinformation, and why it’s an exciting time at the agency.  “Let’s talk about what …

FDA Approves New Nasal Spray to Reverse Overdoses

By Cara Murez  HealthDay Reporter TUESDAY, May 23, 2023 (HealthDay News) — The U.S. Food and Drug Administration on Monday approved a second nasal spray for reversing an opioid overdose. To be sold as Opvee, the spray contains the medication nalmefene hydrochloride and will be available to Americans aged 12 and older with a prescription, …

FDA Approves First Pill to Treat Moderate-to-Severe Crohn’s

By Cara Murez  HealthDay Reporter FRIDAY, May 19, 2023 (HealthDay News) — Patients with Crohn’s disease have a new treatment option, following U.S. Food and Drug Administration approval of a pill called Rinvoq (upadacitinib). Rinvoq is meant to treat adults with moderately to severely active Crohn’s disease who have not had success with TNF (tumor …

Anti-vaxxers twist FDA announcement on deauthorization of certain COVID vaccines

Analysis Conspiracy theorists are claiming that the FDA has banned the COVID vaccine due to either the dangers it poses or its inability to provide protection. But their claims aren’t true. The false allegations began circulating online last week after the FDA announced on April 18 that the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines would …

FDA OKs Second COVID Bivalent Booster for Many Americans

April 18, 2023 – The FDA on Tuesday approved a second bivalent COVID-19 booster for Americans at higher risk, in the hopes of increasing the public’s protection and encouraging more people to get the vaccine, which targets both the original strain of the SARS-CoV-2 virus and two Omicron variants. The Moderna and Pfizer-BioNTech monovalent (single-strain) mRNA …

FDA OKs Second COVID Bivalent Booster for Many Americans

April 18, 2023 – The FDA on Tuesday approved a second bivalent COVID-19 booster for Americans at higher risk, in the hopes of increasing the public’s protection and encouraging more people to get the vaccine, which targets both the original strain of the SARS-CoV-2 virus and two Omicron variants. The Moderna and Pfizer-BioNTech monovalent (single-strain) mRNA …

FDA Approves Drug for Cats With Allergic Skin Disease

By Cara Murez  HealthDay Reporter FRIDAY, March 31, 2023 (HealthDay News) — Cats constantly licking and chewing because of a skin condition called feline allergic dermatitis may benefit from a new generic treatment approved by the U.S. Food and Drug Administration. The FDA approved Modulis for Cats on March 29, making it the first generic …