What Happened, What You Missed: November 6-10, 2023
FDA Approves New Weight Loss Drug from Eli Lilly On Wednesday, the Food and Drug Administration (FDA) approved Eli Lilly’s diabetes drug tirzepatide for chronic weight management as public health undergoes a revolution in the treatment of weight loss. Also known by its commercial name, Zepbound, the drug will be available to adults who are […]
What Happened, What You Missed: July 10-14, 2023
FDA Approves First OTC Birth Control Pill The Food and Drug Administration (FDA) approved the first-ever over-the-counter (OTC) birth control pill for all women of reproductive age. Called Opill, the drug will be available without a prescription at pharmacies, grocery stores, and convenience stores, as well as online. Perrigo, the drug’s manufacturer, estimates that the […]
What Happened, What You Missed: July 3-7, 2023
FDA Fully Approves New Alzheimer’s Drug Leqembi The Food and Drug Administration (FDA) granted full approval to Leqembi, setting up the stage for the Alzheimer’s treatment drug to become the first to receive broad coverage under Medicare. The announcement comes after months of lobbying by Alzheimer’s disease patients and advocates to make the drug more […]
What Happened, What You Missed: March 27-31, 2023
FDA Allows Narcan to Be Sold Over the Counter On Wednesday, the Food and Drug Administration (FDA) approved Narcan, an opioid overdose-reversal drug, to be sold over the counter without a prescription. The announcement comes as opioid overdose deaths hover near record highs. At a press conference, the Director of the White House Office of National Drug Control […]
What Happened, What You Missed: January 2-6, 2023
House Report Criticizes FDA’s Approval of Alzheimer’s Drug The Food and Drug Administration (FDA) inappropriately worked with the drug manufacturer Biogen for approval of the Alzheimer’s disease drug Aduhelm, according to a report from Democrats on two House committees. Originally approved in July 2021, Adulhelm came under intense criticism for its uncertain clinical benefits, high list price, […]
What Happened, What You Missed: December 5-9
Report Calls for FDA to Break Up The Food and Drug Administration (FDA) should be split up to address problems plaguing the agency’s food oversight arm, according to a new report by the Reagan-Udall Foundation. The agency asked the Reagan-Udall Foundation to analyze its operations in the wake of the infant formula crisis earlier this year. According […]
What Happened, What You Missed: November 28-December 2
New Drug Shows Potential to Slow Alzheimer’s Disease The experimental drug lecanemab has the potential to slow the progression of Alzheimer’s disease, according to late-stage clinical trial data from drugmakers Biogen and Eisai. While Phase 2 trial data released in the summer did not show a large difference between lecanemab and a placebo in Alzheimer’s disease patients […]
What Happened, What You Missed: September 5-9
Becerra Authorizes FDA to Issue EUAs for Monkeypox Tests Health and Human Services (HHS) Secretary Xavier Becerra issued an emergency declaration on Wednesday to allow the Food and Drug Administration (FDA) to issue emergency use authorizations (EUAs) for monkeypox tests. The announcement comes one month after HHS declared monkeypox to be a public health emergency. According to […]
What Happened, What You Missed: August 29-September 2
FDA Authorizes Boosters Tailored to BA.5 On Wednesday, the Food and Drug Administration (FDA) authorized bivalent COVID-19 booster shots from Pfizer and Moderna that target both the original COVID-19 strain and the Omicron BA.4/5 subvariants. The Centers for Disease Control and Prevention (CDC) is widely expect to sign-off on the boosters today, which means pharmacies could start […]
Why the Hearing Aid Rule is a Big Deal
On August 16, the Food and Drug Administration (FDA) finalized rulemaking to allow hearing aids to be purchased over-the-counter (OTC), which is widely expected to increase access for millions of Americans with mild to moderate hearing loss. This rule was 5 years in the making – why now? Background While FDA has regulated hearing aids for decades, […]