fda
23 stories tagged "fda"
The FDA Revoked Two Petroleum Dyes That Industry Abandoned Before Most Americans Were Born
Orange B was last certified in 1978. Citrus Red No. 2 has painted Florida oranges since 1959. The six petroleum dyes actually in the food supply remain on a voluntary timeline no manufacturer has publicly signed.
InvestigationsA Pharma-Funded Nonprofit Is Lobbying the FDA to Kill Seven Peptides It Can't Sell You
The Partnership for Safe Medicines has deep ties to the drug lobby. Now it's urging the FDA to permanently block BPC-157, MOTS-c and five other off-patent peptides that compounding pharmacies sell cheap.
Drugs & FDAFor Years, a Foreign Factory Could Put the Active Ingredient in Your Medicine and Never Tell the FDA
The FDA led with a paperwork convenience for manufacturers. Buried underneath was the admission that it can't always trace where a drug's active ingredient was made, a blind spot Congress had to order it to close.
InvestigationsNEJM Retracted the Study That Approved Amgen's Vasculitis Drug. It Had Never Done That in 200 Years.
The FDA says the drug's superiority result came from re-scoring nine patients after the trial was unblinded. It is still on U.S. shelves while Amgen fights the withdrawal.
Drugs & FDAThe FDA Cleared a Sickle-Cell Cure for Two-Year-Olds in 53 Days. It Starts With Chemo That Can Sterilize Them.
Casgevy is a real advance against a brutal disease. It is also a $2.2 million therapy that requires sterilizing chemotherapy, saw a child die in trials, and reached toddlers on a 53-day review Makary's FDA hands out as a favor.
Drugs & FDAThe FDA Office That Vets Gene Therapy Has Run Through Its Entire Top Tier in a Year
The office that decides whether gene therapies reach patients has lost its director, her deputy, and the man brought in to replace them, all inside twelve months.
Drugs & FDAThe FDA's Fix for a $10 Billion Flood of Chinese Vapes Is a Form the Smugglers Will Ignore
Foreign manufacturers ship most of America's vapes and falsify the customs forms to do it. Washington's answer is to ask them to register with the agency they already evade.
InvestigationsHis Heart Was Pumping at 10 Percent. The Real Question Is Why It Took an Algorithm to Notice.
An AI tool flagged a 45-year-old's hidden heart failure and the story became 'AI beats your doctor.' The case actually documents a missed standard workup, and it dropped the same week as the FDA clearance.
InvestigationsThe AI Models Just Failed the Clinical Test We Use to Spot Executive Dysfunction
A new PNAS Nexus study put the same Stroop task neuropsychologists use to screen for executive dysfunction in front of GPT-5, Claude Opus, and Gemini. The accuracy collapse arrives months after the FDA quietly loosened oversight of AI clinical decision support.
Drugs & FDAModerna's mRNA flu shot got a 9-0 vote. The comparator question that killed its first filing did not go away.
An FDA panel voted 9-0 to back Moderna's first mRNA flu vaccine. Four months earlier, the same agency refused to even read the file over the comparator the trial used. The comparator did not change.
Drugs & FDAThe $200K Pediatric Diabetes Shot Just Won a Bigger Label. The Number That Won Isn't the One Families Will Ever See.
The FDA gave Tzield an accelerated nod for kids 8 to 17 newly diagnosed with Stage 3 type 1 diabetes. The C-peptide number won. The endpoints families would actually feel did not.
Drugs & FDAA $200 Flu Pill Just Got a Cheaper Twin. The 10 Percent Resistance Problem Came With It.
The FDA cleared the first generic of baloxavir, the one-pill flu drug, in time for the 2026–2027 season. Cheaper is real. The mutation that turns the drug into a sugar pill is real too.
Drugs & FDAThe FDA Just Approved a Third Over-the-Counter Naloxone. The Maker Once Doubled the Price of the Injectable.
The agency calls Rextovy's OTC approval a win for access. The manufacturer's pricing history, and the market it just walked into, complicate the story.
InvestigationsAaron Siri Wrote a Book Made of Court Filings
A new book by attorney Aaron Siri assembles a decade of FOIA wins, court filings, and depositions into one record of what the federal vaccine docket does and does not say.
Drugs & FDAEurope had this sunscreen in 1999. The FDA approved it Tuesday.
A new chemical UV filter Europe approved in 1999 just cleared the FDA after a 21-year wait, while Americans relied on ingredients the agency's own 2019 review could not call safe.
Drugs & FDAThe Macaques Get a Reprieve. Pharma Gets a Faster Pipeline.
The FDA's new draft guidance lets oncology developers cut animal studies for certain biologics and conjugated products. The replacement laboratory methods are still being validated.
CancerPancreatic cancer's undruggable wall just cracked. The follow-up is 8.5 months and the money was already placed.
Revolution Medicines' daraxonrasib nearly doubled median overall survival versus chemotherapy in previously treated metastatic pancreatic cancer at ASCO 2026, with 8.5 months of follow-up and a two-billion-dollar Royalty Pharma deal already riding on what comes next.
Drugs & FDAAnother Clot Problem at Abiomed: The FDA Flags an Impella Introducer, and the Pattern Keeps Growing
FDA flags Abiomed's 14Fr Low Profile Introducer Kit after a higher than expected complaint rate of clots forming on the device during prolonged Impella CP support. Three serious injuries reported, no deaths. The pattern keeps growing.
Drugs & FDAThe FDA Approved a Better Penile Implant. For Most Men, ED Is the Heart Warning Them First.
The FDA approved Coloplast's Titan Prime inflatable penile prosthesis on June 3, 2026. For the men whose vasculature is past saving, it is a meaningful device upgrade. For most men with new ED, the more useful conversation is what the small arteries are failing to do years before the coronaries noti
Drugs & FDAAndrew Huberman's peptide masterclass and the published evidence
Andrew Huberman's June 1 episode on peptides walks through BPC-157 and seven other compounds. The published human evidence for its lead substance runs to fewer than thirty people.
Drugs & FDAFDA's New Gene Therapy Shortcut Leans on 'Platform Knowledge.' Six Months Ago, They Revoked Sarepta's After Three Patient Deaths.
FDA's new gene therapy draft guidance invites sponsors to lean on "platform knowledge" to streamline submissions, six months after the agency revoked Sarepta's AAVrh74 platform designation following three patient deaths.
Infectious DiseaseXocova clears the FDA. What it actually prevents is the smaller story.
The FDA approved Shionogi's ensitrelvir for post-exposure COVID prevention, citing a 67% relative risk reduction. Look at what the trial actually measured and a different story comes into focus.
Drugs & FDAHepatitis Delta Has Waited Forty-Nine Years for a Drug. The FDA Made American Patients Wait Three Extra.
The FDA cleared bulevirtide for chronic hepatitis delta this week, six years after Europe started using it and three years after a U.S. application was turned down on manufacturing grounds. The wait is its own story.