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Results for search "Drug Approvals".

Health News Results - 30

Experimental Alzheimer's Drug Slows Thinking Declines in Late-Stage Trial

Another experimental drug meant to slow the damage of Alzheimer's appears poised to join a growing arsenal of new treatments for this memory-robbing disease.

In research published online Monday in the Journal of the American Medical Association and presented simultaneously at the Alzheimer's A...

FDA Gives Full Approval to Alzheimer's Drug Leqembi

The U.S. Food and Drug Administration on Thursday gave full approval to the Alzheimer's drug Leqembi, clearing the way for insurance coverage of the pricey drug.

“The full FDA approval will open the floodgates for people with early Alzheimer's to get this drug. It's a big deal because it's very expensive at $26,500 per year,"

  • Robin Foster HealthDay Reporter
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  • July 6, 2023
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  • FDA Approves New Drugs to Treat Type 2 Diabetes in Kids

    The U.S. Food and Drug Administration on Tuesday approved two drugs that have been used in adults with type 2 diabetes for years for use in children aged 10 and up.

    The approvals of Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) provide a new class of medications for pediatric type 2 diabetes. They join metformin, which has been approved for children wi...

    FDA Approves First Pill to Treat Moderate-to-Severe Crohn's Disease

    Patients with Crohn's disease have a new treatment option, following U.S. Food and Drug Administration approval of a pill called Rinvoq (upadacitinib).

    Rinvoq is meant to treat adults with moderately to severely active Crohn's disease who have not had success with TNF (tumor necrosis factor) blockers. The daily pill is the first oral treatment for this group of patients.

    Crohn's is ...

    FDA Approves First Drug Meant to Ease Alzheimer's-Linked Agitation

    A medication to treat agitation in Alzheimer's patients now has approval from the U.S. Food and Drug Administration.

    The FDA gave supplemental approval to Otsuka Pharmaceutical Company Ltd., and Lundbeck Inc. for Rexulti (brexpiprazole) oral tablets on Thursday. Rexulti is the first FDA-approved treatment for these symptoms.

    “Agitation is one of the most common and challenging asp...

    Experimental Alzheimer's Drug Slows Decline in Thinking in Late-Stage Trial

    Another experimental drug meant for Alzheimer's disease looks so promising that drugmaker Eli Lilly plans to ask the U.S. Food and Drug Administration for full approval by the end of June.

    Known as donanemab, the medication clears amyloid plaque from the brain. In a late trial, the drug slowed memory and thinking declines in early symptomatic Alzheimer's patients by more than a third, Li...

    Could a Vibrating Pill Ease Chronic Constipation?

    A new treatment for chronic constipation may bring relief without having to use drugs.

    It's a vibrating pill called Vibrant that stimulates the colon as it passes through the body.

    Although the pill was

  • Cara Murez HealthDay Reporter
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  • February 9, 2023
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  • FDA Approves New 2-Drug Combo Medicine for Asthma

    Adults with asthma now have a new rescue medication to turn to after the U.S. Food and Drug Administration approved Airsupra on Wednesday.

    The drug is the first approved to combine albuterol (a beta-2 adrenergic agonist) and budesonide (a corticosteroid).

    It's mea...

    First FDA-Approved Fecal-Based Treatment Helps Fight a Tough Superbug

    The U.S. Food and Drug Administration on Wednesday approved the first fecal microbiota treatment, aimed at helping adults battling tough-to-treat Clostridium difficile (C. diff) infections.

    "Today's approval of Rebyota is an advance in caring for patients who have recurrent C. difficile infection [CDI]," said

  • Cara Murez HealthDay Reporter
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  • December 1, 2022
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  • A Gene Therapy for Hemophilia That Costs $3.5 Million Gets FDA Approval

    People with one form of the genetic blood disorder hemophilia now have a one-time treatment with a $3.5 million price tag.

    The U.S. Food and Drug Administration approved the new gene therapy Hemgenix on Nov. 22. Soon after, drugmaker CSL Behring revealed its cost.

    The company said its drug would ultimately reduce health care costs because patients with the genetic disorder would ne...

    FDA Approves New ALS Drug Despite Uncertain Data

    The U.S. Food and Drug Administration on Thursday gave its approval to a new drug for ALS (amyotrophic lateral sclerosis), also known as Lou Gehrig's disease.

    But appro...

    Hints That Experimental Drug Might Curb a Form of ALS

    People with a rare genetic form of ALS may benefit from extended use of an investigational drug, a new study shows.

    The medication, tofersen, benefited patients with mutations of the gene SOD1. These mutations create a misfolded version of a protein, which leads to amyotrophic lateral sclerosis, also kn...

    Merck's COVID Pill Appears Effective, But May Pose Pregnancy Risks: FDA

    Merck's experimental COVID-19 antiviral pill appears effective, but may pose risks for pregnant women, including birth defects and toxicity to developing fetuses, according to the U.S. Food and Drug Administration.

    On Friday morning Merck announced

  • Robert Preidt and Robin Foster
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  • November 29, 2021
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  • FDA Panel Advisor Who Panned New Alzheimer's Drug Speaks Out

    An outside advisor to the U.S. Food and Drug Administration's review of the controversial Alzheimer's drug Aduhelm is now speaking out, arguing that the approval was based on dodgy science and involved questionable collaboration between regulators and the drug's maker.

    "I'm not surprised at the controversy because I think it's a horrible decision. I think the FDA got it wrong," said Dr. G...

    Doctors Divided Over Use of Controversial New Alzheimer's Drug

    The controversial new Alzheimer's drug Aduhelm is creating something of a civil war in medicine, as health networks, hospitals, insurers and individual doctors weigh impending discussions with patients about whether they should take the medication.

    Many doctors believe the U.S. Food and Drug Administration "moved the goalposts" to approve Aduhelm (aducanumab) in early June, and they aren'...

    FDA Approves First Lymphoma Drug for Dogs

    The first full approval of a drug to treat lymphoma in dogs has been granted by the U.S. Food and Drug Administration.

    "While canine lymphoma affects fewer than 70,000 dogs in the U.S. annually, it accounts for up to 24% of all cancers in dogs, making it one of the most significant canine cancers," Steven Solomon, director of the FDA's Center for Veterinary Medicine, said in an agency new...

    FDA Defends Approval of Controversial Alzheimer's Drug

    The U.S. Food and Drug Administration has approved the first new drug to treat Alzheimer's disease in nearly two decades, in a controversial decision that left the agency defending its reputation and its science.

    Aduhelm (aducanumab) treats Alzheimer's by clearing out amyloid beta, a sticky protein known to form plaques in the brains of early-stage patients.

    It is the first approved...

    'Historic' Decision Expected on U.S. Approval of Alzheimer's Drug

    The first drug ever shown to slow the progression of Alzheimer's disease could be approved by the U.S. Food and Drug Administration on Monday, but experts say that approval will be surrounded by controversy.

    In clinical trials, aducanumab showed a 22% reduction in the development of thinking and memory problems associated with Alzheimer's disease, according to a statement from the Alzheim...

    Race Against Time: Stricken With ALS, She's Seeking Access to Experimental Drug

    Like many proud moms, Lisa Stockman-Mauriello of Summit, N.J., is looking forward to exciting milestones in lives of her three sons over the coming months: One will graduate college, one will enter college, and the third will begin high school.

    But unlike other moms, it's not guaranteed that she'll be there to experience them.

    Lisa, 51, has amyotrophic lateral sclerosis (ALS), a di...

    FDA Approves First Once-a-Month HIV Therapy

    The first monthly shots to treat adults with HIV were approved by the U.S. Food and Drug Administration on Thursday.

    "Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition. This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen," said Dr. John...

    Immunotherapy Drug Boosts Survival for Lung Cancer Patients

    A newly approved drug for the leading form of the number one cancer killer, lung cancer, does improve patient survival, a new study confirms.

    The immunotherapy drug Tecentriq (atezolizumab) was approved earlier this year by the U.S. Food and Drug Administration to treat patients with newly diagnosed non-small cell lung cancers (NSCLC), which comprise up to 85% of all lung tumors.<...

    FDA OKs First Generic Version of Daraprim, Best Known as the 'Pharma Bro' Drug

    The first generic version of Daraprim (pyrimethamine) tablets for the treatment of toxoplasmosis has been approved by the U.S. Food and Drug Administration.

    "Today's approval is especially important for populations that are more susceptible to toxoplasmosis infections, such as pregnant women and individuals with HIV or AIDS, by paving the way for more choices in treatment options," FD...

    New Drugs Getting FDA's Blessing Faster, but Is That a Good Thing?

    New drugs are being approved by the U.S. Food and Drug Administration for patients based on less and less solid evidence, thanks to incentive programs that have been created to promote drug development, a new study shows.

    Researchers report that more than 8 out of 10 new drugs in 2018 benefitted from at least one special program that streamlines the approval process.

    The res...

    FDA Gives First Ebola Vaccine for Adults the Green Light

    The first Ebola vaccine approved by the U.S. Food and Drug Administration is a single-dose injection called Ervebo.

    The vaccine from Merck & Co. is approved to protect against the Zaire ebolavirus in people 18 and older.

    In the United States, Ebola infections are rare. Confirmed cases have involved people in other countries who became infected and then traveled to...

    FDA Approves First Generic Forms of MS Drug Gilenya

    The first generic versions of the multiple sclerosis drug Gilenya have been approved by the U.S. Food and Drug Administration.

    The three generic versions of Gilenya (fingolimod) capsules were approved for the treatment of relapsing forms of multiple sclerosis (MS) in adults.

    "Approving safe and effective generics so patients have more treatment options continues to be a prio...

    FDA Approves Drug for Most Deadly Form of TB

    A new drug has been approved as part of a powerful, three-pronged treatment regimen for the most deadly strain of tuberculosis, the U.S. Food and Drug Administration announced Wednesday.

    Pretomanid tablets were approved to be used with bedaquiline and linezolid in adults with extensive multidrug-resistant tuberculosis (XDR-TB) of the lungs. Caused by a bacterium that attacks the lung...

    Second New MS Drug Secures FDA Approval

    The U.S. Food and Drug Administration has approved another new multiple sclerosis drug -- the second in one week.

    Mavenclad (cladribine) pills can be used to treat relapsing forms of MS in adults, including relapsing-remitting disease and active secondary progressive disease. The drug is not recommended for MS patients with a course of the disease known as clinically isolated syndrome...

    FDA OKs Blood Pressure Drug to Ease Shortage Due to Recalls

    The U.S. Food and Drug Administration on Tuesday approved a new generic version of the high blood pressure/heart failure drug valsartan, saying the move might help ease the current medication shortage.

    The agency said it prioritized review of the drug from Alkem Laboratories Ltd. after multiple recalls of other generic valsartan products depleted supplies.

    Those recalls occ...

    Why Do More and More Americans Use Medical Marijuana?

    Easing chronic pain is the main reason Americans use medical marijuana, a new study finds.

    "We wanted to understand the reasons why people are using cannabis medically, and whether those reasons for use are evidence-based," said lead author Kevin Boehnke. He's an investigator at University of Michigan's Chronic Pain and Fatigue Research Center.

    Boehnke and his colleagues exa...

    Generic Version of Popular Asthma Inhaler Wins FDA Approval

    The first generic version of the widely used Advair Diskus inhaler for asthma and chronic obstructive pulmonary disease (COPD) has won U.S. Food and Drug Administration approval.

    This approval "is part of our longstanding commitment to advance access to lower cost, high-quality generic alternatives," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Researc...