Supreme Court rules in abortion medication case, finds group lacked standing to challenge FDA approval
In a victory for the Biden administration and abortion rights supporters, the high court gave a unanimous decision that challengers to the FDA lacked standing to sue the government.

While Mifepristone Remains FDA-Approved, Threats to Abortion Access Remain
The attack on medication abortion could continue, as the case will be sent back down to federal district court judge Matthew Kacsmaryk, who has already allowed the states of Kansas, Missouri, and Idaho to intervene in the case.

FDA took months to react to complaint about Abbott infant formula factory, audit finds
The U.S. Food and Drug Administration took more than 15 months to act on a whistleblower complaint it received about conditions at an Abbott Nutrition factory that was at the center of a nationwide shortage of infant formula, a new audit shows.

Alzheimer’s Drug with Modest Benefits Gets Green Light from FDA Advisers
The drug donanemab slows progression of symptoms in people with early stages of Alzheimer’s disease, but questions linger about the durability of its effect.

‘What the hell are you waiting for?’ Senators grill FDA, DOJ about lack of action on youth vaping epidemic
Republicans and Democrats on the US Senate Judiciary Committee showed rare agreement Wednesday as they took to task the US Food and Drug Administration and the US Department of Justice for what they described as inaction on the country’s youth vaping epidemic.

FDA says Vivani Medical can begin study of long-term GLP-1-eluting implant
The FDA lifted the clinical hold on Vivani’s NPM-119, allowing the initiation of its LIBERATE-1 Phase 1 clinical trial. This trial looks at the safety, tolerability and pharmacokinetics of NPM-119 (exenatide), the company’s miniature, six-month GLP-1 implant in development for the treatment of type 2 diabetes.

FDA to healthcare supply chain: Prepare for hurricanes
The FDA recommended that medical device stakeholders, including hospitals, suppliers and distributors, should hone their natural disaster contingency plans.

FDA Approves Repotrectinib for NTRK Gene Fusion-Positive Solid Tumors
The FDA granted accelerated approval to repotrectinib to treat adult and pediatric patients with NTRK gene fusion-positive solid tumors.

Cranbury Pharmaceuticals Receives FDA Approval for First Generic Version of Emflaza Oral Suspension
Deflazacort oral suspension is indicated to treat DMD in patients five years of age and older. DMD is a rare genetic disorder characterized by progressive muscle degeneration and weakness.

Cucumber Recall Updated, FDA Reveals Almost 70 Hospitalizations
An earlier recall has been updated and health officials have issued a warning after 68 people were hospitalized from eating the recalled food.









 

 

 




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