Search Results for: FDA

A Texas federal court Thursday granted the US Food and Drug Administration’s (FDA) motion to dismiss a lawsuit brought against them for authorizing COVID-19 vaccine administration to children. The FDA filed to dismiss the lawsuit based on lack of subject-matter jurisdiction and failure to state a claim. The US District Court for the Western District of [...]

The US Food and Drug Administration (FDA) Tuesday announced that it will allow Mifepristone, a drug used during a medication abortion, to be dispensed by certified retail pharmacies. Mifepristone is used in conjunction with Misoprostol to terminate pregnancies of up to ten weeks’ gestation without the need for surgical intervention. Previously, the drug could only [...]

The US House Committees on Oversight and Reform & Energy and Commerce Thursday jointly released a report criticizing the US Food and Drug Administration’s (FDA) approval of Alzheimer’s drug Aduhelm. The report says that the FDA and Aduhelm-manufacturer Biogen acted in concert to get the drug approved in a hastened manner despite doubts about Aduhelm’s [...]

The Centers for Disease Control and Prevention (CDC) Wednesday announced the US will require a negative COVID-19 test for airline travelers from China before boarding. The CDC announced the order to slow the spread of COVID cases in the US during China’s current surge of COVID cases. The announcement noted the “lack of adequate and [...]

The US Food and Drug Administration (FDA) Thursday announced it will change label information on emergency contraceptive Plan B One Step to accurately reflect that the drug is not an abortifacient. Based on updated clinical data, the FDA determined: Plan B One-Step will not work if a person is already pregnant, meaning it will not [...]

New Zealand Tuesday passed the Smokefree Environments and Regulated Products Bill to prohibit anyone born on or after January 1, 2009, from ever purchasing cigarettes. The law will usher in a lifetime ban to prevent future generations from being able to purchase cigarettes and lowers allowable nicotine content in New Zealand products to 0.8 milligrams per [...]

E-cigarette maker JUUL will pay 37 states $439 million to settle an investigation into its youth-marketing practices according to a Tuesday statement from Texas Attorney General Ken Paxton. In addition to the payments to 37 states, the settlement will reportedly force JUUL to comply with “strict injunctive terms severely limiting their marketing and sales practices.” [...]

An abortion-inducing drug’s manufacturer has dropped its lawsuit challenging Mississippi’s restrictions on the provision and use of the drug, in connection with “the changed national landscape” in the wake of the US Supreme Court ruling in Dobbs v. Jackson. GenBioPro Inc., which manufacturers mifepristone, a generic medical abortion pill approved by the US Food and [...]

The first plaintiff scheduled to go to trial against drug manufacturers for the heartburn medication Zantac Tuesday dropped his suit. Joseph Bayer, who claimed Zantac (also known as ​​ranitidine) caused him to develop esophageal cancer, told the court and drug manufacturers that he intended to file a notice of voluntary dismissal. Notably, there was no settlement [...]

Biotech giants BioNTech and Pfizer Monday filed a complaint for declaratory judgment of noninfringement in the US District Court of Massachusetts. The companies seek to quell claims by CureVac of intellectual property violations. BioNTech and Pfizer collaborated in the development and distribution of their COVID-19 vaccine. The Pfizer-BioNTech vaccine, trademarked as COMIRNATY®, was the first successful [...]