FDA

Latest articles

5h
Business Wire
GSK Submits Landmark IMPACT Data to US Regulatory Authority to Support Expanded Label for Trelegy ElliptaINVA) today announced the filing of a supplemental New Drug Application (sNDA)
Business Wire / Posted 5 hours ago
INVA) today announced the filing of a supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) for the use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, ‘FF/UMEC/VI’) for an expanded indication... Read more
7h
Business Standard India
Founded by 2 Gujaratis, US drug major Amneal eyes speciality biz in Indiapackaging facility in East Hanover, New Jersey. Becomes the 7th largest generic
Business Standard India / Posted 7 hours ago
packaging facility in East Hanover, New Jersey. Becomes the 7th largest generics company in the US (in TRx) 2012: US FDA approves new API and FDF facilities in India 2013: Acquires 1,000+ MAs from Pfizer. Acquires assets from Actavis and... Read more
7h
KXXV Waco
Experts: Vaping with nicotine increases chance of strokethese are tobacco-free, little to no research has been done to see if the produ
KXXV Waco / Posted 7 hours ago
these are tobacco-free, little to no research has been done to see if the product is still harmful to people, and the FDA is just beginning to regulate it. Many vape juices still contain nicotine. The juices that do not, and just contain... Read more
10 related articles
7h
FOX 11 Tucson
Experts: Vaping with nicotine increases chance of strokethese are tobacco-free, little to no research has been done to see if the produ
FOX 11 Tucson / Posted 7 hours ago
these are tobacco-free, little to no research has been done to see if the product is still harmful to people, and the FDA is just beginning to regulate it. Many vape juices still contain nicotine. The juices that do not, and just contain... Read more
10 related articles
7h
KPLC Lake Charles
Experts: Vaping with nicotine increases chance of strokethese are tobacco-free, little to no research has been done to see if the produ
KPLC Lake Charles / Posted 7 hours ago
these are tobacco-free, little to no research has been done to see if the product is still harmful to people, and the FDA is just beginning to regulate it. Many vape juices still contain nicotine. The juices that do not, and just contain... Read more
10 related articles
8h
WAFB Baton Rouge
Miracle or menace? Experts and users weigh in on kratomthat makes your own body stop making the normal chemicals you need," said Catal
WAFB Baton Rouge / Posted 8 hours ago
that makes your own body stop making the normal chemicals you need," said Cataldie. Now the Food and Drug Administration (FDA) echoed those fears, calling kratom addictive and potentially deadly, especially when combined with other drugs. In a... Read more
9h
5News Ft. Smith-Fayetteville
New Machine For Mammograms Could Change Healthcare For WomenThe FDA just approved GE Healthcare’s new Pristina mammography machine with a r
5News Ft. Smith-Fayetteville / Posted 9 hours ago
The FDA just approved GE Healthcare’s new Pristina mammography machine with a remote control. “This device is built with comfort in mind,” said Patricia Benton with GE Healthcare. “It’s built for women, by women.” The company brought the equipment... Read more
10h
WBTV Charlotte
This device helps cancer patients keep their hair, here’s why you haven’t heard of itof each woman, she said. For patients who choose scalp cooling treatment, not
WBTV Charlotte / Posted 10 hours ago
of each woman, she said. For patients who choose scalp cooling treatment, not everyone will keep all of their hair. In an FDA clinical trial of 101 women who used the DigniCap system, about two-thirds lost less than half of their hair. For Smith,... Read more
11h
13 WMAZ Macon
Georgia teenager needs prescription drug that costs $37-thousand a yearthat this drug was being available. I said this was it, she will be able to hav
13 WMAZ Macon / Posted 11 hours ago
that this drug was being available. I said this was it, she will be able to have a childhood," Johnson said. The drug was FDA approved in March, but when her doctor wrote the prescription it was denied. "The doctor would do a prior authorization... Read more
12h
First Coast News
Georgia teenager needs prescription drug that costs $37-thousand a yearthat this drug was being available. I said this was it, she will be able to hav
First Coast News / Posted 12 hours ago
that this drug was being available. I said this was it, she will be able to have a childhood," Johnson said. The drug was FDA approved in March, but when her doctor wrote the prescription it was denied. "The doctor would do a prior authorization... Read more
12h
WAFB Baton Rouge
What is kratom and why do some want it to be illegal?of kratom, which can last between five and seven hours, or even longer in highe
WAFB Baton Rouge / Posted 12 hours ago
of kratom, which can last between five and seven hours, or even longer in higher doses. The Food and Drug Administration (FDA) is concerned that some users take it for its euphoric effects, which they believe can lead to abuse of the... Read more
15h
Bizjournals
FDA warns against ‘do it yourself’ gene therapy kitsmedicines and technologies available to the masses, often by circumventing regu
Bizjournals / Posted 15 hours ago
medicines and technologies available to the masses, often by circumventing regulators. A statement posted on the FDA’s website on Tuesday cautions that it is illegal to sell gene therapy products and kits intended for self-administration.... Read more
15h
Metro Silicon Valley
Heather David's Coffee Table Tome Plumbs the Kooky History of Golden State MotelsShe adds: "The thing about Pulse-A-Rhythm beds is that they promised a cure for
Metro Silicon Valley / Posted 15 hours ago
She adds: "The thing about Pulse-A-Rhythm beds is that they promised a cure for pretty much everything. And the FDA came along and said, 'Unh unh uh' and made them pull all the devices off the mattresses and put them out of business. So... Read more
16h
FOX 59 Indianapolis
What’s the reality of medical marijuana becoming legal in Indiana?a bill that is really right for Hoosiers.” Firm skeptics include influential p
FOX 59 Indianapolis / Posted 16 hours ago
a bill that is really right for Hoosiers.” Firm skeptics include influential players like Hill. “If those products get FDA approval, I think that provides the legislature far firmer ground than substituting the FDA approval process with a... Read more
16h
Baltimore Sun
'Corrective' tobacco ads to run in The Baltimore Sun, other media starting this weekendads to reduce smoking. “This industry has changed dramatically over the last 2
Baltimore Sun / Posted 16 hours ago
ads to reduce smoking. “This industry has changed dramatically over the last 20 years, including becoming regulated by the FDA, which we supported,” said a written statement from Murray Garnick, Altria’s executive vice president and general counsel... Read more
85 related articles
17h
Daily Mail
Peter Thiel sells most of remaining Facebook stakewent on to clarify that the procedure was of interest as a personal-health trea
Daily Mail / Posted 17 hours ago
went on to clarify that the procedure was of interest as a personal-health treatment, and said it would not require FDA approval. Thiel was a major supporter Donald Trump prior to the 2016 presidential election. But Danzeisen was 'much... Read more
4 related articles
17h
Daily Mail
Latest meningitis vaccine prevents almost all formsControl and Prevention (CDC) and at pharmaceutical company GlaxoSmithKline, man
Daily Mail / Posted 17 hours ago
Control and Prevention (CDC) and at pharmaceutical company GlaxoSmithKline, manufacturer of the vaccine. The latest FDA-approved meningitis vaccine could prevent more than 90 percent of the dangerous virus's forms in the US, according to... Read more
17h
Business Wire
Key Aspects of the Global Cranial Implants Marketof product portfolio to establish their presence in the market. The growing dem
Business Wire / Posted 17 hours ago
of product portfolio to establish their presence in the market. The growing demand for cost-effective products, growing FDA approvals, and increase in demand for PSIs will intensify the competition among local and global vendors present in the... Read more
17 related articles
17h
FOX Business
The 3 Stocks on the MFM Team's Radar This WeekYeah, who is this guy? Hill: Steve Broido, question about Sangamo Technologies
FOX Business / Posted 17 hours ago
Yeah, who is this guy? Hill: Steve Broido, question about Sangamo Technologies? Steve Broido: When I hear "waiting for FDA approval" I want to run for the door, because it seems like so many businesses are just waiting for that critical FDA... Read more
17h
FOX Business
The 3 Stocks on the MFM Team's Radar This WeekYeah, who is this guy? Hill: Steve Broido, question about Sangamo Technologies
FOX Business / Posted 17 hours ago
Yeah, who is this guy? Hill: Steve Broido, question about Sangamo Technologies? Steve Broido: When I hear "waiting for FDA approval" I want to run for the door, because it seems like so many businesses are just waiting for that critical FDA... Read more
19h
Greenville Advocate
Daniels awarded Kline scholarshipAn FDA student’s ability to lead and inspire others has earned him a lower bill
Greenville Advocate / Posted 19 hours ago
An FDA student’s ability to lead and inspire others has earned him a lower bill for his college textbooks. Braxton Daniels has been named the recipient of Troy University’s Dr. John Kline Excellence in Leadership Award, with the $500 in scholarship... Read more
19h
WHAS TV11 Louisville
Exploring treatment options for prostate, testicular cancersa sexual function standpoint after HIFU. WW: Is HIFU a common procedure now, o
WHAS TV11 Louisville / Posted 19 hours ago
a sexual function standpoint after HIFU. WW: Is HIFU a common procedure now, or is it still gathering speed? JE: It was FDA-approved in 2015 and since that time the number of patients who’ve been getting HIFU in the Louisville area has been... Read more
19h
Sun Star
FDA pushes sanctions vs. some ‘products’THE Food and Drugs Administration (FDA) has strengthened its efforts in running
Sun Star / Posted 19 hours ago
THE Food and Drugs Administration (FDA) has strengthened its efforts in running after businesses that are selling beauty products without licenses from the FDA, after over P10 million worth of unregistered beauty and other drug products were found in... Read more
20h
Fortune
The 6 Tech Stories to Watch for Next Yeargoing forward (the total global market could exceed $100 billion by 2022), espe
Fortune / Posted 20 hours ago
going forward (the total global market could exceed $100 billion by 2022), especially as the Food and Drug Administration (FDA) moves to make it easier for mHealth apps to reach the market.Travis Kalanick resurfaces Americans love second acts.... Read more
21h
The Gilmer Mirror
Your Taxpayer Dollars Are Funding Corporate Propaganda - Your Taxpayer Dollars Are Funding Corporate Propaganda Congress wants to spend millions peddling corporate talking points on GMOs. By Anna Meyer While Congress hasn’t accomplished much in 2...Agricultural Biotechnology Education and Outreach Initiative. That’s a partners
The Gilmer Mirror / Posted 21 hours ago
Agricultural Biotechnology Education and Outreach Initiative. That’s a partnership between the Food & Drug Administration (FDA) and the Department of Agriculture (USDA) “to provide consumer education on agricultural biotechnology and food and... Read more
21h
FOX News
FDA approves first 2-drug HIV regimen NEW YORK – The U.S. Food and Drug Administration on Tuesday approved the firs
FOX News / Posted 21 hours ago
NEW YORK – The U.S. Food and Drug Administration on Tuesday approved the first two-drug regimen to treat HIV, the virus that causes AIDS, aimed at easing the side effects for long-term patients who are on the... Read more
6 related articles
21h
FOX News
FDA approves first 2-drug HIV regimencould be slow because rilpivirine has the downside that it must be taken with a
FOX News / Posted 21 hours ago
could be slow because rilpivirine has the downside that it must be taken with a meal at the same time every day. The FDA has a February deadline to decide on Gilead's competing combination. GSK is also working on a second two-drug... Read more
6 related articles
21h
The Hill
As tech firms enter hearing aid market, FDA must protect consumersThe Food and Drug Administration (FDA) has started consulting with hearing expe
The Hill / Posted 21 hours ago
The Food and Drug Administration (FDA) has started consulting with hearing experts and associations as it begins creating regulations for new over-the-counter hearing aids. Having worked with hearing loss patients for more than 25 years, however, I... Read more
22h
KRBC Abilene & KTAB Abilene
Big Tobacco's court-ordered ads make their debutto the court order. "This industry has changed dramatically over the last 20 y
KRBC Abilene & KTAB Abilene / Posted 22 hours ago
to the court order. "This industry has changed dramatically over the last 20 years, including becoming regulated by the FDA, which we supported," Murray Garnick, Altria's executive vice president and general counsel, said in the... Read more
85 related articles
22h
WCYB 5 Tri-Cities
Big Tobacco's court-ordered ads make their debutto the court order. "This industry has changed dramatically over the last 20 y
WCYB 5 Tri-Cities / Posted 22 hours ago
to the court order. "This industry has changed dramatically over the last 20 years, including becoming regulated by the FDA, which we supported," Murray Garnick, Altria's executive vice president and general counsel, said in the... Read more
85 related articles
22h
KRDO Colorado Springs
Big Tobacco's court-ordered ads make their debutto the court order. "This industry has changed dramatically over the last 20 y
KRDO Colorado Springs / Posted 22 hours ago
to the court order. "This industry has changed dramatically over the last 20 years, including becoming regulated by the FDA, which we supported," Murray Garnick, Altria's executive vice president and general counsel, said in the... Read more
85 related articles
22h
KRCR TV Redding
Big Tobacco's court-ordered ads make their debutto the court order. "This industry has changed dramatically over the last 20 y
KRCR TV Redding / Posted 22 hours ago
to the court order. "This industry has changed dramatically over the last 20 years, including becoming regulated by the FDA, which we supported," Murray Garnick, Altria's executive vice president and general counsel, said in the... Read more
85 related articles
22h
News Channel 12 New Bern
Big Tobacco's court-ordered ads make their debutto the court order. "This industry has changed dramatically over the last 20 y
News Channel 12 New Bern / Posted 22 hours ago
to the court order. "This industry has changed dramatically over the last 20 years, including becoming regulated by the FDA, which we supported," Murray Garnick, Altria's executive vice president and general counsel, said in the... Read more
85 related articles
22h
Daily Mail
Cold remedy reduces breast cancer aggressiveness by up to 80%may 'starve' tumours, preventing their growth. Professor Lisanti said: 'Our id
Daily Mail / Posted 22 hours ago
may 'starve' tumours, preventing their growth. Professor Lisanti said: 'Our idea was to repurpose an inexpensive FDA-approved drug, to examine if its antioxidant properties could target the feeding behavior of cancer cells.' 'We haven't... Read more
22h
Business Wire
Puma Biotechnology and Specialised Therapeutics Asia Enter into Exclusive Licensing Agreement to Commercialize NERLYNX® (neratinib) in Australia, New Zealand and South East Asiafor NERLYNX in Australia by the second quarter of 2019.” Neratinib was approve
Business Wire / Posted 22 hours ago
for NERLYNX in Australia by the second quarter of 2019.” Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer... Read more
22h
FOX Business
Mazor Robotics Might Need to Worry About This Potential Rival the Most ( It's Not Intuitive SurgicalGMED). New to the scene -- sort of Globus Medical received clearance from the
FOX Business / Posted 22 hours ago
GMED). New to the scene -- sort of Globus Medical received clearance from the U.S. Food and Drug Administration (FDA) for its Excelsius GPS robotic guidance and navigation system in August. That clearance came after the company... Read more
22h
FOX Business
Mazor Robotics Might Need to Worry About This Potential Rival the Most ( It's Not Intuitive SurgicalGMED). New to the scene -- sort of Globus Medical received clearance from the
FOX Business / Posted 22 hours ago
GMED). New to the scene -- sort of Globus Medical received clearance from the U.S. Food and Drug Administration (FDA) for its Excelsius GPS robotic guidance and navigation system in August. That clearance came after the company... Read more
22h
Springfield News-Sun
‘Tragic result’: Some use opioid treatment drug to get highsay is more difficult to conceal. Dhira called the move is a step in the right
Springfield News-Sun / Posted 22 hours ago
say is more difficult to conceal. Dhira called the move is a step in the right direction, but he’d like to see all FDA-approved treatment options covered by Medicaid without prior authorization. Medicaid pays for about half of all... Read more
2 related articles
22h
KESQ Palm Springs
Big Tobacco's court-ordered ads make their debutto the court order. "This industry has changed dramatically over the last 20 y
KESQ Palm Springs / Posted 22 hours ago
to the court order. "This industry has changed dramatically over the last 20 years, including becoming regulated by the FDA, which we supported," Murray Garnick, Altria's executive vice president and general counsel, said in the... Read more
85 related articles
23h
ABC 7 El Paso
Big Tobacco's court-ordered ads make their debutto the court order. "This industry has changed dramatically over the last 20 y
ABC 7 El Paso / Posted 23 hours ago
to the court order. "This industry has changed dramatically over the last 20 years, including becoming regulated by the FDA, which we supported," Murray Garnick, Altria's executive vice president and general counsel, said in the... Read more
85 related articles
23h
News 8000
Big Tobacco's court-ordered ads make their debutto the court order. "This industry has changed dramatically over the last 20 y
News 8000 / Posted 23 hours ago
to the court order. "This industry has changed dramatically over the last 20 years, including becoming regulated by the FDA, which we supported," Murray Garnick, Altria's executive vice president and general counsel, said in the... Read more
85 related articles
23h
KTXS Abilene
Big Tobacco's court-ordered ads make their debutto the court order. "This industry has changed dramatically over the last 20 y
KTXS Abilene / Posted 23 hours ago
to the court order. "This industry has changed dramatically over the last 20 years, including becoming regulated by the FDA, which we supported," Murray Garnick, Altria's executive vice president and general counsel, said in the... Read more
85 related articles
23h
KECI Missoula
Big Tobacco's court-ordered ads make their debutto the court order. "This industry has changed dramatically over the last 20 y
KECI Missoula / Posted 23 hours ago
to the court order. "This industry has changed dramatically over the last 20 years, including becoming regulated by the FDA, which we supported," Murray Garnick, Altria's executive vice president and general counsel, said in the... Read more
85 related articles
23h
Business Wire
Preceptis Medical宣佈針對中國的B輪融資和全球成長策略Sun先生擔任戰略顧問,負責整體合作夥伴關係和策略規劃。 耳管手術是美國最常見的兒科手術(每年為120萬例),目前病童須在全身麻醉下進行手術,這也是迄今為止
Business Wire / Posted 23 hours ago
Sun先生擔任戰略顧問,負責整體合作夥伴關係和策略規劃。 耳管手術是美國最常見的兒科手術(每年為120萬例),目前病童須在全身麻醉下進行手術,這也是迄今為止唯一的選擇。Hummingbird TTS是唯一獲得FDA核准,可使用清醒鎮靜術來進行耳管手術的產品;藉此,麻醉師能夠按照這一快速小手術的需求來調整鎮靜程度。Preceptis Medical, Inc.執行長Steve Anderson表示:「美國臨床試驗和商用試行計畫顯示,Hummingbird... Read more
106 related articles
23h
Business Wire
Preceptis Medical宣布面向中国的B轮融资和全球增长战略Sun先生担任战略顾问,负责全局伙伴关系和战略规划。 耳置管术是美国最常见的儿科手术(每年为120万例),目前患儿须在全身麻醉下手术,这也是迄今为止唯一的选
Business Wire / Posted 23 hours ago
Sun先生担任战略顾问,负责全局伙伴关系和战略规划。 耳置管术是美国最常见的儿科手术(每年为120万例),目前患儿须在全身麻醉下手术,这也是迄今为止唯一的选择。Hummingbird TTS是唯一获得FDA核准用于意识清醒下镇静实施耳置管术的产品;藉此,麻醉师能够按照这一快速小手术的需求来调整镇静程度。Preceptis Medical, Inc.首席执行官Steve Anderson表示:“美国临床试验和试商用显示,Hummingbird... Read more
106 related articles
1d
WCNC Charlotte
Nearly 800 without power after equipment failureuntil 2 p.m. This is not good news for those families with a refrigerator full
WCNC Charlotte / Posted yesterday
until 2 p.m. This is not good news for those families with a refrigerator full of food for Thanksgiving. According the the FDA: Keep the refrigerator and freezer doors closed as much as possible to maintain the cold temperature. The refrigerator... Read more
2 related articles
1d
Bangor Daily News
How a cranberry crisis changed the way Americans see foodOak headquarters. The time marked a pivotal change for the government agency, J
Bangor Daily News / Posted yesterday
Oak headquarters. The time marked a pivotal change for the government agency, Junod said. The cranberry crisis pushed the FDA into the public consciousness, and once it was there, it remained. “They knew to perk their ears up and pay attention if... Read more
1d
Springfield News-Sun
‘Tragic result’: Some use treatment drug to get highsay is more difficult to conceal. Dhira called the move is a step in the right
Springfield News-Sun / Posted yesterday
say is more difficult to conceal. Dhira called the move is a step in the right direction, but he’d like to see all FDA-approved treatment options covered by Medicaid without prior authorization. Medicaid pays for about half of all... Read more
2 related articles
1d
Lowell Sun
Bay State startup wants to revive Vioxxaffecting fewer than 200,000 Americans, and comes with benefits, including tax
Lowell Sun / Posted yesterday
affecting fewer than 200,000 Americans, and comes with benefits, including tax credits on testing costs and a free FDA review. Still, it's no slam-dunk. Sippy said the Massachusetts-based Tremeau must raise $25 million or more to pay for... Read more
112 related articles
1d
Daily Mail
Can sex stretch out your vagina? Gynecologists set the record straighton health service...Heart failure kills more Britons than four most common...Fi
Daily Mail / Posted yesterday
on health service...Heart failure kills more Britons than four most common...First two-drug HIV treatment regimen gets US FDA approval Share this article The vagina does stretch during sex. Intercourse with a larger penis will stretch it... Read more
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