Original Post For Immediate Release: June 13, 2022 Today, the U.S. Food and Drug Administration approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the U.S. each year. Today’s action marks the first FDA approval of…
Read MoreOriginal Post For Immediate Release: June 10, 2022 Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s recent increased flexibilities. Company (Product Origin): Abbott (Spain) Product(s): Similac Total Comfort Stage 1 (0-12 months), Similac Total Comfort…
Read MoreOriginal Post Summary Company Announcement Date: June 07, 2022 FDA Publish Date: June 07, 2022 Product Type: Drugs Reason for Announcement: Product contains elevated levels of Bacillus cereus Company Name: Buzzagogo Inc. Brand Name: Allergy Bee Gone for Kids Product Description: Nasal Swab Remedy Company Announcement FOR IMMEDIATE RELEASE – June 07, 2022 – Nottingham,…
Read MoreOriginal Post For Immediate Release: June 03, 2022 Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s recent increased flexibilities. Company (Product Origin): Nestlé (Mexico) Product(s): Gerber Good Start Gentle Type of Formula: General Estimated Quantity: About 1.3…
Read MoreOriginal Post Do not eat, serve, or sell FreshKampo or HEB brand organic strawberries purchased between March 5, 2022, and April 25, 2022, FDA’s investigation is ongoing The FDA, along with CDC, and state and local partners, is investigating a multistate outbreak of hepatitis A infections in the United States linked to fresh organic strawberries.…
Read MoreOriginal Post For Immediate Release: May 27, 2022 Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula on U.S. store shelves in the coming weeks and months. “We continue to work around the clock with our government partners and industry…
Read MoreOriginal Post For Immediate Release: May 26, 2022 Today, the U.S. Food and Drug Administration is providing an update on steps it has taken that will lead to millions of bottles of specialized medical infant formula to help address immediate needs for infants with certain allergies or critical health conditions. This type of specialized medical…
Read MoreOriginal Post Coronavirus Q&As for Consumers The FDA is working to address the coronavirus disease 2019 (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about vaccine boosters, and resources. Q: Am I eligible for a first booster dose of a COVID-19…
Read MoreOriginal Post What’s New May 24, 2022 The FDA has announced that it will exercise enforcement discretion with respect to the specific infant formula products listed below, to increase infant formula supplies in the United States. This list will be updated on a regular basis. Companies Receiving Enforcement Discretion for Infant Formula Country Company Product…
Read MoreOriginal Post UPDATE: On May 19, 2022, the FDA updated this web page to help ensure patients and providers have important information about the recall of these critical devices. See What the FDA is Doing for more information. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous…
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