Drugs & FDA
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For Years the Muscle Aches Were Called a Nocebo Effect. A McMaster Lab Found Statins Injuring the Muscle Cell Itself.
An estimated 7 to 29 percent of statin users report muscle pain. The flagship trial called most of it a placebo response. In mouse and human muscle cells, a McMaster team has now traced a cholesterol-independent pathway by which statins damage muscle directly.
Drugs & FDAThe FDA Twice Called This Melanoma Trial Uninterpretable. Then It Approved the Drug, at $450,000 a Course.
Federal reviewers rejected Replimune's melanoma therapy twice, faulting a single-arm trial they called not adequate and well-controlled and its results uninterpretable. No new controlled data ever answered them. After a 10-3 advisory vote, the FDA approved it anyway, at $450,000 a course.
Drugs & FDAGilead Priced Its Near-Perfect HIV Shot Out of the Countries Where the Virus Is Spreading Fastest
Lenacapavir drove new HIV infections to nearly zero across two Gilead trials and a year-long extension. Gilead lists it at $28,218 a year in America; researchers estimate generics could be made for as little as $25, and the fastest-growing epidemics were left off the cheap-generic map.
Drugs & FDAU.S. Special Operators Carried French Freeze-Dried Plasma for 15 Years Before the FDA Licensed an American One
Allied militaries and U.S. commandos have relied on freeze-dried plasma for years. Washington licensed its own version this week, decades after an American doctor first invented the powder.
Drugs & FDAThe FDA Cleared a CRISPR Cure for Two-Year-Olds Whose Own Trial Enrolled No One That Young
Casgevy's pediatric trials enrolled 11 children aged five and up, yet the FDA extended the $2.2 million therapy down to age two, where the conditioning chemo can permanently sterilize a child too young to bank eggs or sperm.
Drugs & FDARice Chemists Taught an Enzyme to Recycle Drug Synthesis's Most Expensive Ingredient
The chemistry that builds drugs like Spinraza just got cheaper. The $125,000 price tag never had much to do with the chemistry.
Drugs & FDAThe FDA Approved the First Cholesterol Pill of Its Kind Before Its Trial Could Show It Prevents Heart Attacks or Deaths
Lipfendra lowers LDL cholesterol by up to 60 percent. The 14,550-patient trial that would show whether that prevents heart attacks or deaths does not finish until November 2029, and Merck is charging roughly $3,800 a year in the meantime.
Drugs & FDAThe Blue Light Over Your Fish Tank Is Now Building Drug Molecules
University at Buffalo chemists swapped harsh UV for a soft blue LED and got something the old chemistry rarely gives: two modifications to a molecule from a single reaction step.
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.
Drugs & FDAA $440,000 Drug Proved This Obesity Was Never About Willpower
Brain-tumor surgery can wreck the hypothalamus and leave hunger permanently switched on. Setmelanotide restored the missing signal in a real placebo-controlled trial, then arrived priced near half a million dollars a year.
Drugs & FDAThe Last Time Washington Went After Hospital Drug Markups, the Supreme Court Blocked It. This Time CMS Brought Receipts.
In 2018 the Supreme Court blocked CMS from cutting the markup 340B hospitals charge Medicare for discounted drugs, because the agency skipped a required survey. CMS ran the survey this time, and found seniors paying co-pays bigger than what the hospital paid for the drug.
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 Standard Treatment for Nerve Damage Was Never Built to Repair a Nerve
Gabapentin is the seventh most prescribed drug in America, handed out for neuropathy it was never shown to reverse. A retired researcher's drug-free protocol asks the question the pharmacy aisle can't: what if you removed the cause instead?
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.
Drugs & FDAThe FDA Pulled Infigratinib as a Cancer Drug in 2024. It Just Passed Phase 3 in Children With Dwarfism.
The FDA pulled infigratinib as a failed cancer drug in 2024. Now its maker says the same pill grows children with dwarfism faster, on a surrogate no one has yet shown reaches adulthood.
Drugs & FDAThe Immune System's Guardrails Were Too Rare to Study. A Bonn Lab Just Grew Them in a Dish.
A German lab built a way to grow follicular regulatory T cells from precursors in a dish, opening a notoriously hard-to-study brake on antibody production to direct experiment.
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 & 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 & 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.
Drugs & FDAA heart-attack drug just regrew kidney tissue in mice, and the receipts have no pharma on them
A UCLA monoclonal antibody designed to help hearts heal after a heart attack also repaired injured kidneys in mice, and it was developed without a dollar of pharma money.
Drugs & FDATestosterone Prescriptions Quadrupled. The Workups Didn't.
A Michigan Medicine chart review presented at ENDO 2026 found that only 12 percent of men prescribed testosterone got the guideline-required workup, even as the U.S. wrote 11 million testosterone prescriptions in 2024.
Drugs & FDAAstellas Brings Real-World Numbers for Its Menopause Drug to ENDO 2026. The Black Box Warning Stayed Home.
Astellas presented its first real-world numbers for Veozah at ENDO 2026, framed as a win. The 656-woman observational study had no placebo arm and the company's release did not mention the FDA black-box warning for liver injury.