Tag: FDA approval

First Medical Device To Treat ADHD In Children Gets FDA Approval

FDA gave the green light to the first medical device designed to treat ADHD. Results of clinical trials showed promise, lowering symptoms of children diagnosed with moderate to severe disorder.

Neuroscience April 23, 2019

FDA Approves Pediatric Vaccine That Protects Children From 6 Diseases

The Food and Drug Administration approved Sanofi and Merck's vaccine called Vaxelis. This will protect kids from six diseases of the 14 that the Centers for Disease Control and Prevention advised to get immunized against.

Public Health December 27, 2018

First Cannabis-Based Drug Approved By FDA Now Available Nationwide

The first FDA-approved cannabis-based medication is finally available across the United States. Epidiolex is an oral solution that is approved for use in patients 2 years and older.

Medicine November 4, 2018

Artificial Iris Implant Approved By FDA, But Not Everyone Can Change Eye Color

The Food and Drug Administration approved the CustomFlex Artificial Iris, the first artificial iris implant in the United States. The implant will benefit patients with missing or damaged irises due to aniridia, traumatic injury, albinism, and melanoma.

Medicine June 1, 2018

A Seizure Drug Made From Marijuana Is This Close To Getting FDA Approval

GW Pharmaceuticals awaits FDA approval for Epidiolex, which contains an element derived from cannabis. It will treat children suffering from two rare forms of epilepsy by making their seizures less frequent.

Medicine April 18, 2018

FDA Approves First Medical Device To Use Artificial Intelligence For Diabetic Patients

FDA approved a device programmed with artificial intelligence that would precisely identify mild diabetic retinopathy. It's the pioneering AI-based tool that has been allowed for market release.

Medicine April 12, 2018

Bayer Essure System For Permanent Birth Control Receives Label Update

Once again, the American Food and Drug Administration slapped restrictions on Bayer for its controversial Essure implant. The device now comes with a checklist that must be signed by the patient before insertion.

Public Health April 10, 2018

World's Smallest Mechanical Heart Valve Saves Life Of 3-Year-Old Girl

Sadie Rutenberg was born with a huge hole inside her heart. Thanks to this miraculous heart valve by Abbott, she is now thriving at three years old.

Medicine April 10, 2018

FDA Approves First Gene Therapy For Inherited Disease

Luxturna was recently approved for the treatment of a blindness-causing RPE65 gene mutation. With two injections in each eye, patients diagnosed with a hereditary retinal dystrophy would be able to experience improved vision.

Medicine December 20, 2017

Curing Blindness Through Gene Therapy Might Soon Be Allowed By The FDA

Patients whose blindness is a result of an RPE65 gene might soon consider Luxturna, a form of gene therapy that improves vision. Its approval will soon be deliberated by the U.S. Food and Drug Administration.

Biotech October 10, 2017

FDA Grants Approval For First-Ever Neonatal MRI Device

The U.S. FDA has granted Aspect Imaging a 510(k) clearance for its Embrace Neonatal MRI device. Embrace is the first MRI designed for babies in the NICU.

Medicine July 22, 2017

FDA Approves Portola Drug Betrixaban For Blood Clot Prevention

The Food and Drug Administration has approved betrixaban for preventing blood clotting among patients with deep vein thrombosis. The oral treatment is the first extended duration treatment for hospitalized acutely ill patients.

Medicine June 23, 2017

In A First, FDA OKs Cancer Treatment For Tumors With Specific Genetic Feature

Keytruda, Merck's immunotherapy drug, now enjoys FDA drug approval. In a bold move, the agency OK'd the drug based on specific genetic features, not where the tumor originally appeared in the body.

Medicine May 24, 2017

FDA Approves New ALS Treatment Drug After 20 Years

The FDA approves an intravenous drug for treating amyotrophic lateral sclerosis (ALS) more than 20 years after the first drug was approved. The drug’s price will be steep in the United States.

Medicine May 6, 2017

FDA Approves Vagus Nerve Therapy For Cluster Headaches

The Food and Drug Administration has approved the use of a handheld vagus nerve stimulation device in the treatment of cluster headaches. More than 350,000 people suffer from this extremely painful illness.

Public Health April 19, 2017

FDA Approves Novartis Kisqali As Metastatic Breast Cancer Treatment

The new cancer drug developed by Novartis called Kisqali was approved by the FDA as a first-line treatment for metastatic breast cancer. The pill is intended as a combination treatment, designed for postmenopausal women who battle the condition.

Medicine March 15, 2017

Injectable Psoriasis Drug Siliq Receives FDA Approval

Millions of people live with psoriasis in the United States. For those dealing with moderate to severe cases of the autoimmune condition, the FDA approved the injectable drug Siliq (brodalumab) as another treatment option.

Healthy Living/Wellness February 18, 2017

Corticosteroid Emflaza Receives FDA Approval As Duchenne Muscular Dystrophy Treatment

A new drug approved by the FDA has been shown to delay loss of walking ability for patients diagnosed with Duchenne muscular dystrophy. Emflaza is marketed by Marathon Pharmaceuticals.

Medicine February 10, 2017

Actemra Achieves Positive Trial Results As Giant Cell Arteritis Treatment, Receives Priority Review Designation From FDA

Actemra achieved positive results at the end of the Phase III trial, and its Supplemental Biologics License Application was accepted by the FDA. The medication is employed in treating patients who suffer from giant cell arteritis.

Medicine January 24, 2017

FDA OKs Constipation Drug From Synergy Pharma

The FDA has approved the one-a-day tablet Trulance of Synergy Pharmaceuticals for treating chronic idiopathic constipation in adults. The one-a-day tablet is the pharma's first to obtain regulatory clearance.

Medicine January 20, 2017

FDA Approves Egalet Long-Acting Opioid Painkiller With Abuse-Deterrent Properties

After an independent panel voted for the approval of Egalet Corp's Arymo ER back in August 2016, the FDA released a statement approving the drug. However, the medication does not meet the requirements for claims of deterring snorting.

Public Health January 11, 2017

Biogen’s Spinraza Receives FDA Approval, Becomes First Drug For Spinal Muscular Atrophy

The United States now has its first spinal muscular atrophy drug. The FDA has approved Biogen’s Spinraza (nusinersen) on Dec. 23 as treatment for the rare and often fatal genetic disease affecting both children and adults.

Medicine December 24, 2016

FDA Fast-Tracks Approval For Advanced Ovarian Cancer Drug Rucaparib

A new ovarian cancer treatment has been approved by the FDA. Rubraca (rucaparib) for women diagnosed with a certain type of advanced ovarian cancer received accelerated approval from the agency.

Medicine December 22, 2016

Bayer Seeks FDA Approval For Regorafenib As Liver Cancer Treatment

German drugmaker Bayer on Monday submitted an sNDA proposal to the FDA for the extension of its drug Regorafenib as a second-line treatment for liver cancer. The drug is currently used to treat colorectal cancer.

Medicine November 8, 2016

Theranos Closes Labs And Wellness Centers, Lays Off 340 Employees

Theranos announced that it is closing its labs and wellness centers in multiple states, and is laying-off 340 people in the process. The biotech company used to be seen as a promising startup, but the tide has changed.

Business Tech October 6, 2016

FDA Grants Accelerated Approval For Sarepta Muscular Dystrophy Drug Eteplirsen

The FDA has approved the first drug to treat Duchenne muscular dystrophy. The agency's decision went against the recommendation of the panel of experts who did not find eteplirsen effective.

Medicine September 20, 2016

FDA Approves Gilead Drug That Can Treat All Forms Of Hepatitis C Virus

FDA green-lighted the first drug that can treat all major forms of the viral disease hepatitis C. How effective is Gilead's Epclusa and how much does it cost?

Medicine June 29, 2016

FDA Approves New Immunotherapy Medication For Blood, Bladder Cancers

The FDA approved on May 18 two new immunotherapy drugs, including atezolizumab for advanced bladder cancer. These medications are designed to boost the immune system's own ability to find and kill cancer cells.

Medicine May 19, 2016

Flexion Osteoarthritis Knee Pain Drug Found Effective In Late-Stage Study

Flexion Therapeutics' Zilretta osteoarthritis drug is reported to have met its goals in a late-stage study, inching closer to FDA approval. A couple of months back, the drug failed to show statistically significant pain relief during its mid-stage trial.

Life February 17, 2016

FDA Approves Merck’s Hepatitis C Pill Zepatier

Millions of Americans are infected by the hepatitis C virus. The FDA approval for Zepatier provides patients with genotype 1 and 4 infections another treatment option to improve prognosis for their condition.

Life January 29, 2016

FDA Approves Eisai’s Halaven As Treatment For Liposarcoma

Halaven has received the FDA’s approval as a chemotherapy option. It adds to the list of treatments that could be prescribed to patients with liposarcoma, a soft tissue sarcoma that forms in fat cells.

Life January 29, 2016

FDA Strengthens Rules For Using Mesh Implants In Pelvic Surgeries

The FDA said pelvic mesh implants used for pelvic organ prolapse surgeries in women will now be classified as class III or high-risk devices. It also started to require a pre-market approval application from manufacturers showing the products' safety and effectiveness.

Life January 6, 2016

FDA Approval Of First-Of-A-Kind Drugs Highest In 19 Years

The FDA approved 45 drugs with never-before-sold ingredients in the U.S. last year, surpassing 2014’s total of 41 approved drugs. Rising prescription drug prices, R&D challenges, and the development of new cancer treatments are some crucial industry issues in 2016.

Life January 5, 2016

FDA Approval Could Make Free Autoimmune Disorder Drug Pricey

Autoimmune disorder drug Firdapse could get an FDA approval soon, which will make the experimental LEMS medication available via a doctor's prescription. However, health officials said this could make the drug's price surge and make it even more difficult for patients to access.

Life December 24, 2015

FDA Approves Eli Lilly's Drug Basaglar For Diabetes Treatment

Basaglar diabetes drug is a long-acting, man-made human insulin therapy recently approved by the FDA. It is made by Eli Lilly in partnership with Boehringer Ingelheim as a cheaper version of Sanofi's Lantus drug.

Life December 17, 2015

Genetically Engineered Salmon Become First Modified Food Animal Approved For Human Consumption

Salmon genetically modified to grow faster get FDA approval despite opposition from food safety and environmental groups. After years of GMO fruits and vegetables being available, FDA issues the first approval of a GMO food animal.

Life November 20, 2015

FDA Approves Easy-To-Use Nasal Spray Narcan As Treatment For Opioid Overdose

FDA approved Narcan (naloxone) nasal spray, a drug used for opioid overdose treatment previously approved only in injectable forms. This spray will be launched in January by Ireland-based Adapt Pharma.

Life November 19, 2015

FDA Approves Sale of New Snus Smokeless Tobacco Products

Snus, or tobacco powder, has been a popular non-smoking tobacco product in Sweden. The FDA cleared distribution of the product to the U.S. market.

Society November 11, 2015

FDA Panel Recommends Approval Of Merck Drug Sugammadex To Reverse Effect Of Muscle Relaxant

After several years and rejections, Merck & Co's drug sugammadex gets another chance to win FDA approval when an independent panel voted for the administration to do so this month. If it does come to pass, sugammadex will be the first drug of its kind in the U.S. to address neuromuscular block problems during surgery.

Life November 9, 2015

FDA Gives Approval To Amgen Melanoma Drug That Uses Herpes Virus To Fight Cancer

Amgen's Melanoma drug made history as the first drug of its kind to get an FDA approval. The drug uses a genetically engineered herpes virus to attack tumors using an immune system compound.

Life October 28, 2015

Gout Drug Lesinurad By AstraZeneca Receives Approval Recommendation From FDA Advisory Committee

Lesinurad is a step closer towards achieving FDA approval as the agency’s Arthritis Advisory Committee has recommended that the drug be approved for use in the U.S.

Life October 24, 2015

Blood Test Startup Theranos Faces Scrutiny: FDA Says Nanotainer An 'Unapproved Medical Device'

Medical tech startup Theranos aimed to revolutionize the way blood samples are tested with their Nanotainer device and Edison machine. The California-based company is now being scrutinized by the FDA for the products' accuracy and novelty.

Life October 17, 2015

FDA Approves Alkermes' Aristada Drug As Schizophrenia Treatment

Alkermes announced that the FDA has approved its extended-release injectable for schizophrenia treatment. Aristada, poised to be launched immediately, will offer once-a-month and six-week dosing options.

Life October 6, 2015

FDA Gives AstraZeneca Brilinta Nod Of Approval For Longer-Term Use

Heart attack patients remain at risk beyond a year after the incident. FDA’s approval makes BRILINTA available as another treatment option to reduce rates of cardiovascular death.

Life September 6, 2015

Frances Oldham Kelsey, Who Saved The U.S. From Thalidomide Disaster, Dies At 101

Frances Oldham Kelsey, a Canadian doctor who saved the United States from widespread birth defects in the '60s, has passed away. How did Thalidomide come so close to causing massive damage in American newborns?

Life August 9, 2015

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