Tag: FDA regulations
FDA Advisory Panel Divided on Mandating Covid-19 Vaccine Updates
Alright, so the Food and Drug Administration’s expert vaccine panel had a bit of a disagreement on whether Covid-19 vaccine manufacturers should update the strain of the virus they are targeting in their products....
FDA Considers PDUFA Changes and Compounded Weight Loss Drugs
It's a beautiful morning at the Pharmalot campus, where the sun is shining, and a gentle breeze is blowing. The short person is still catching some Z's, and the official mascots are on guard...
Trump’s FDA and NIH Picks, FDA Office Crunch: Pharmalittle Update
As the week comes to a close, many of us are looking forward to some well-deserved rest and relaxation. Personally, I'm excited to spend time with loved ones, walk my furry friends, and enjoy...
Challenges at FDA & bluebird Bio Sale: What You Need to Know
This morning, Praxis Precision Medicine announced that an independent data monitoring committee recommended discontinuing a Phase 3 study involving its experimental treatment for essential tremors. The analysis indicated that the drug was unlikely to...
The Impact of FDA’s Removal of Mifepristone on Reproductive Health
The Battle Over Mifepristone: Reproductive Healthcare at RiskIn a landmark decision that could shape the future of reproductive healthcare in the United States, a federal judge in Texas has ruled to remove mifepristone, a...
Former FDA Chief Seeks to Undermine RFK Jr.’s Senate Confirmation
Former FDA Chief Expresses Concerns Over RFK Jr.'s Senate ConfirmationIn a recent television appearance, Scott Gottlieb, the former commissioner of the Food and Drug Administration under the Trump administration, has raised red flags with...
‘Bust Big Pharma Bus Tour and Smoking-Cessation Drugs: Pharmalittle News’
Good morning, readers, and welcome back to the start of another work week. As we prepare to dive back into our usual routines of meetings, commutes, and deadlines, let's take a moment to savor...
FDA Rejects MDMA and Nasal Spray for Allergic Reactions: Pharmalittle Update
Good morning everyone, hope you had a restful weekend and are ready to tackle the new week ahead. As we sip on some refreshing blueberry cobbler, let's dive into some interesting updates. The U.S....
FDA Requests Further Research before Approving MDMA Therapy
The Food and Drug Administration (FDA) recently declined to approve MDMA-assisted therapy for the treatment of post-traumatic stress disorder (PTSD), citing insufficient data to support its use. The FDA requested additional clinical trials to...
FDA Regulations on Food Additives: Are Unsafe Ingredients Slipping Through the Cracks?
The Food and Drug Administration's approach to regulating food additives has come under scrutiny, with concerns that unsafe ingredients may be slipping through the cracks and entering the nation's food supply. An editorial published...
New FDA-Approved Overdose-Reversal Medication by Purdue Pharma
Purdue Pharma, infamous for its role in the opioid crisis, has received FDA approval for a new auto-injector device designed to reverse opioid overdoses. The device, known as Zurnai, uses nalmefene, a potent version...
New Title: Soft-Tissue Cancer Drug Approval and Zepbound Shortage Update: Pharmalittle News
Good morning, this is Jonathan Wosen, reporting on the latest news in the biotech and life sciences world. The FDA has recently approved a new treatment for a rare soft tissue cancer. This cutting-edge...
