drug-safety
13 stories tagged "drug-safety"
Most of Finland's 'Low T' Men Reported Good Health 15 Years On, Even at Levels One Online Clinic Set Out to Treat
Finnish men in the bottom quarter for testosterone at 31 reported health and quality of life at 46 that didn't differ significantly from the top quarter, though their median level fell under the only treatment cutoff a 2022 secret-shopper study found among online platforms.
CancerCompass Plans to File a Biliary Cancer Drug Without the Survival Trial the FDA Asked For
Tovecimig plus chemotherapy shrank more biliary tract tumors than chemotherapy alone, but median survival was 8.9 months against 9.4, and 93.5 percent of the combination arm had grade 3 or worse adverse events. The FDA recommended a survival trial before filing. Compass plans to file anyway.
CancerHengrui's Breast Cancer Drug More Than Doubled Progression-Free Survival While Severe Anemia Hit Four in Ten Patients
Trastuzumab rezetecan pushed median progression-free survival to 16.4 months from 6.8 on chemotherapy in 551 patients, all treated in China, while grade 3 or worse anemia reached 42.8 percent against 4.8 percent.
Drugs & FDAGSK's Hepatitis B Drug Got a Label That Reaches Patients It Functionally Cured About One Time in 14
Below 1,000 IU/mL of surface antigen, 26 percent of treated patients reached functional cure. Between 1,000 and 3,000, a range the FDA's label also covers, GSK's own counts work out to about 7 percent, for a weekly injection boxed for serious liver reactions and low platelets.
Autoimmune & InflammationArthritis From Cancer Immunotherapy Comes Back With the Same T Cell Clones
Joint fluid drawn at a first flare and again at a relapse held the same expanded T cell clones, with a stronger inflammatory signature the second time. The durable immune memory these cancer drugs are sold on has a cost in the joints.
Drugs & FDAThe First-Line Glaucoma Drop That Flatters Its Own Pressure Reading
Across 128 eyes followed at one VA clinic, the corneas that thinned most on prostaglandin drops made the pressure gauge read 3.3 mm Hg low, and those eyes lost visual field nearly twice as fast.
Autoimmune & InflammationNovartis Halted Eight Autoimmune CAR-T Trials After Three Deaths, Then Called the Killer a "Known Risk"
Three people in Novartis's rap-cel trials died after a runaway inflammatory syndrome, and Bristol Myers froze enrollment in its rival product. Faster manufacturing is the leading suspect, and no public report yet says how many patients got the drug.
Drugs & FDAKennedy's Peptide Plan Reaches the White House, and Wall Street Is Already Counting the Money
Peptides already sell on a Queens bodega shelf, so moving them into licensed pharmacies is progress. Whether it protects anyone depends on one missing rule: test each lot and report every injury.
Drugs & FDAThe FDA's Former Biologics Chief Says Public Health Can't See the Next Disaster Coming
Vinay Prasad ran the FDA's biologics center until this spring. His warning: the apparatus chases lettuce recalls and measles while a blood test for dozens of cancers heads toward Medicare with its central question unanswered.
Drugs & FDAThe FDA Approved Narcolepsy's First Orexin Agonist. Takeda's Last One Was Pulled for Liver Injury.
Takeda's oveporexton switches on the orexin receptor that narcolepsy type 1 patients can no longer signal. The company's last orexin drug was halted in 2021 after patients crossed serious liver-injury thresholds.
Drugs & FDAFor 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 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.
Metabolic & WeightRetatrutide's Triple-Receptor Triumph Came With a One-in-Five Skin-Sensation Signal Nobody Wanted to Linger On
Eli Lilly's investigational retatrutide hit bariatric-surgery-level weight loss at ADA 2026. The highest-dose arm of TRIUMPH-4 also saw 20.9% of patients report abnormal skin sensations, and a small cardiac imbalance turned up in the type-2 trial. Both got far less stage time than the headline numbe