clinical trials

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FDA Approves Shot to Prevent HIV Needed Just Twice a Year

In clinical trials, Yeztugo almost eliminated transmission

(Newser) - A new HIV prevention shot that requires just two injections a year has received FDA approval after clinical trials showed it nearly eliminated HIV transmission—offering fresh hope in the decades-long fight against the virus. Yeztugo, whose generic name is lenacapavir, is produced by Gilead Sciences, NBC News reports....

Think Weight-Loss Meds Beat Surgery? Maybe Reconsider

Bariatric surgery still outperforms injections for long-term weight loss, researchers find

(Newser) - A new study suggests that popular weight-loss injections like Wegovy and Mounjaro don't deliver the same dramatic results in everyday use as they do in clinical trials. The drugs, which contain semaglutide and tirzepatide, have been hailed for helping some trial participants lose up to 20% of their...

NIH Staffers Risk Their Careers With Open Letter

Dozens sign name to letter protesting cuts, and hundreds more sign anonymously

(Newser) - More than 300 current and former National Institutes of Health employees have taken the unusual step of publicly protesting deep funding cuts, staff firings, and "policies that undermine the NIH mission." Details:
  • Read the open letter here . It was sent to NIH director Jay Bhattacharya, health secretary
...

Pfizer Halts Obesity Pill Tests Amid Safety Concerns

Phase 3 trial for danuglipron has been paused due to potential liver injury

(Newser) - Pfizer's pursuit of a daily pill to tackle obesity has hit a setback. The pharmaceuticals giant has paused development of its oral obesity drug, danuglipron, after a possible liver injury experienced by a trial participant. The incident occurred during phase 3 testing, the final stage before seeking regulatory...

A Single Shot Might Lower Heart Attack Risk for Some
Experimental Drug Erases
Harmful Protein From Blood
NEW STUDY
Mar 31, 2025 11:54 AM CDT

Experimental Drug Erases Harmful Protein From Blood

Researchers hope reducing Lp(a) levels will also reduce risk of heart attack and stroke

(Newser) - Up to one in five people in the US have elevated levels of a lipoprotein in the blood that may raise their risk of heart attack and stroke by 25% to 50%. For now, there's not much that can be done for those with high levels of Lipoprotein(a) or...

USAID Shutdown Efforts Are 'Chaotic,' 'Tectonic'
USAID Shutdown Efforts
Are 'Chaotic,' 'Tectonic'
THE RUNDOWN
Feb 7, 2025 9:19 AM CST

USAID Shutdown Efforts Are 'Chaotic,' 'Tectonic'

US farmers to lose out on sales; patients stranded with devices, experimental drugs in their bodies

(Newser) - The Trump administration is intent on dismantling the US Agency for International Development, which delivers food, medicine, and other humanitarian aid to the world's poorest. The stop-work order on USAID, which is now under the purview of Marco Rubio's State Department, immediately halted the agency's disbursement of...

This Drug 'Could Change the Trajectory' of HIV Epidemic

Gilead's Sunlenca prevents infections in girls and young women who get a twice-yearly shot

(Newser) - A twice-yearly shot was 100% effective in preventing HIV infections in young women and teen girls, according to the results of what some are calling a "breakthrough" phase 3 trial. The randomized, double-blind trial by drugmaker Gilead Sciences involved more than 5,000 young women and girls in South...

FDA: LSD Is Now a Breakthrough Therapy

Mind Medicine's anxiety-treating MM120 granted designation ahead of Phase 3 trials

(Newser) - The FDA has bestowed breakthrough therapy status on an LSD formulation found to relieve symptoms of anxiety and depression with a single dose. Mind Medicine's MM120 (lysergide d-tartrate) is used to treat generalized anxiety disorder. Twelve weeks after receiving a dose in a Phase 2 trial, 48% of patients...

Trial Raises Hope for Psilocybin as Depression Treatment

Regulatory approval could come 'potentially within a few years' time'

(Newser) - One or two doses of psilocybin, the active ingredient in magic mushrooms, has been found to help people with cancer , alcohol problems , anxiety, and depression , and now those with a severe, treatment-resistant form of depression, according to researchers. A phase 2 randomized, double-blind clinical trial involving 233 people with treatment-resistant...

After Aduhelm Debacle, New Alzheimer's Drug Emerges

Biogen, partner Eisai: Clinical trial for lecanemab shows promising 27% slowing of cognitive decline

(Newser) - Last year, the FDA approved aducanumab , marketed as Aduhelm , a controversial drug made by Biogen and its Japanese partner Eisai to treat Alzheimer's. Things didn't go well, though, with expert opposition to the costly medication and a final death blow to its place in the market after Medicare...

Hope on Horizon for Painful, Incurable Hand Disease

Known drug appears to reverse progress of early-stage Dupuytren's disease

(Newser) - You probably take for granted the ability to stick your hand in your pocket, use a keyboard, and grip a steering wheel. But all this can be challenging for sufferers of a painful and incurable disease that causes fibrotic scar tissue to develop at the base of the fingers. In...

Ivermectin Has No Benefit Against COVID
Ivermectin Won't
Protect You From COVID
NEW STUDY
Mar 31, 2022 6:47 AM CDT

Ivermectin Won't Protect You From COVID

Double-blind, randomized trial found it did not reduce hospitalizations even if taken early

(Newser) - Treating COVID-19 patients with ivermectin did not alleviate the illness or reduce hospitalizations, according to a major double-blind, randomized clinical trial published Wednesday, which effectively rules out the anti-parasitic drug as a treatment. "There's really no sign of any benefit," Dr. David Boulware, an infectious-disease expert at...

Merck's COVID Pill Trial Went So Well It Was Halted Early

Emergency use authorization could be next for antiviral drug molnupiravir after positive results

(Newser) - The makers of what could be the first antiviral pill for COVID-19 said Friday that they will request emergency use authorization in the US as soon as possible. An independent board of experts monitoring the clinical trial of molnupiravir from drug-maker Merck and Ridgeback Biotherapeutics recommended it be halted early...

Cheap, Accessible Drug May Offer Hope for Aggressive Cancer

Researchers hope aspirin will boost immunotherapy in new clinical trial

(Newser) - A trial is underway to determine whether an aggressive breast cancer might be treated with help from an inexpensive and widely available drug: aspirin. Researchers at the Christie NHS Foundation Trust in Manchester, England, will test whether aspirin makes difficult-to-treat tumors more responsive to cancer-fighting drugs, as animal studies suggest,...

Pfizer, Moderna to Add Children to Trials

FDA wants more data on myocarditis

(Newser) - The availability of coronavirus vaccines for younger children could be delayed, after the Food and Drug Administration asked Pfizer and Moderna to expand its trials. The agency wants to know if a rare inflammation of the heart muscle that has surfaced in young adults would more of a problem in...

Psychedelic Drug Shows Great Promise for PTSD Sufferers

Therapy assisted by MDMA (aka ecstasy) could be approved by 2023

(Newser) - Ecstasy appears on track to become an FDA-approved prescription treatment if the results of the first Phase 3 trial on psychedelic-assisted therapy are any indication. As the New York Times reports, 67% of PTSD patients who were given a dose of the drug during therapy no longer qualified for a...

Drugmaker Pauses Trial of COVID Antibody Treatment

Eli Lilly says it's for safety reasons, without elaborating

(Newser) - Drugmaker Eli Lilly, working to come up with an antibody treatment for COVID-19, has paused its phase three clinical trials after an independent data safety monitoring board (DSMB) raised concerns. "Safety is of the utmost importance to Lilly," a company spokeswoman said in a statement Tuesday, reports CNBC...

Scientists: We've Found a Lifesaving COVID Treatment
Scientists: We've Found a
Lifesaving COVID Treatment
NEW STUDY
Jun 16, 2020 10:25 AM CDT

Scientists: We've Found a Lifesaving COVID Treatment

Dexamethasone found to reduce death rates by 1/3 for patients on ventilators

(Newser) - Researchers running the largest randomized, controlled trial of coronavirus treatments are heralding a "major breakthrough": the first drug shown to reduce deaths from COVID-19. Dexamethasone isn't new. Rather, it's a generic steroid widely used to reduce inflammation. But it's "the only drug that's so...

HIV Vaccine Trial Ends in Failure and 'Deep Disappointment'
Agency Calls Off 
HIV Vaccine Trial
IN CASE YOU MISSED IT
Feb 8, 2020 10:30 AM CST

Agency Calls Off HIV Vaccine Trial

Results from South Africa show vaccine wasn't effective

(Newser) - "An HIV vaccine is essential to end the global pandemic, and we hoped this vaccine candidate would work," a US health agency said Monday. "Regrettably, it does not." With that, the clinical trial in South Africa was shut down, CNN reports; the vaccine was not found...

Startup Bets 'Young Blood,' Taken Literally, Fights Aging

Clinical trial underway, but you have to pay to play

(Newser) - If you'd like to fill your veins with the blood of young people, you need only drain your bank account of $8,000. That's right, young blood is now joining the ever-growing ranks of "cures" people are paying for to combat age-related diseases and even aging itself....

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