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Results for search "Drug Approvals".

Health News Results - 30

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

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

06 Jul
FDA Gives Full Approval to Alzheimer's Drug Leqembi

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 ...

21 Jun
FDA Approves New Drugs to Treat Type 2 Diabetes in Kids

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) provid...

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

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 (t...

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

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 ...

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

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 lat...

09 Feb
Could a Vibrating Pill Ease Chronic Constipation?

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

12 Jan
FDA Approves New 2-Drug Combo Medicine for Asthma

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 f...

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

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 f...

23 Nov
A Gene Therapy for Hemophilia That Costs $3.5 Million Gets FDA Approval

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.

30 Sep
FDA Approves New ALS Drug Despite Uncertain Data

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

23 Sep
Hints That Experimental Drug Might Curb a Form of ALS

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

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

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

28 Jul
FDA Panel Advisor Who Panned New Alzheimer's Drug Speaks Out

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.

"...

23 Jul
Doctors Divided Over Use of Controversial New Alzheimer's Drug

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 t...

16 Jul
FDA Approves First Lymphoma Drug for Dogs

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 ...

07 Jun
FDA Defends Approval of Controversial Alzheimer's Drug

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 am...

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

'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 de...

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

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...

22 Jan
FDA Approves First Once-a-Month HIV Therapy

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...

01 Oct
Immunotherapy Drug Boosts Survival for Lung Cancer Patients

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 tr...

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

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 infection...

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

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...

20 Dec
FDA Gives First Ebola Vaccine for Adults the Green Light

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, Ebo...

06 Dec
FDA Approves First Generic Forms of MS Drug Gilenya

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...

15 Aug
FDA Approves Drug for Most Deadly Form of TB

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 a...

01 Apr
Second New MS Drug Secures FDA Approval

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...

13 Mar
FDA OKs Blood Pressure Drug to Ease Shortage Due to Recalls

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 Labo...

05 Feb
Why Do More and More Americans Use Medical Marijuana?

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 inv...

31 Jan
Generic Version of Popular Asthma Inhaler Wins FDA Approval

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, h...