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The FDA Is Holding a Breast Implant Safety Hearing Next Week—Here’s What to Know

Following hundreds of reports linking certain breast implants to chronic illness, cancer and even death, the Federal Drug Administration (FDA) will hold hearings on Monday and Tuesday to discuss their safety. One topic on the agenda is the link between breast implants and a rare type of lymphoma called anaplastic large cell lymphoma, or BIA-ALCL. As of press time, there are 457 women in the U.S. diagnosed with the specific cancer; globally, 17 have died. Similar to the FDA’s initial ...


FDA rejects Sanofi-Lexicon add-on pill for type 1 diabetes

The U.S. Food and Drug Administration declined to approve a drug developed by Sanofi SA and Lexicon Pharmaceuticals Inc intended for use with insulin in patients with type 1 diabetes, the companies said on Friday. The decision comes about two months after an FDA advisory panel failed to reach a consensus over whether the once-daily oral drug, sotagliflozin, should be approved as an add-on to insulin therapy. The setback comes as Sanofi works to revive declining sales from its diabetes division...


Jazz Pharma's sleep disorder treatment gets FDA nod

By Aakash B (Reuters) - The U.S. Food and Drug Administration approved Jazz Pharmaceuticals Plc's treatment for patients with a form of sleep disorder, the company said on Wednesday. The drug, solriamfetol, will treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA). The decision is a big win for the drugmaker whose patents covering its blockbuster narcolepsy drug, Xyrem, was declared invalid by a U.S. appeals court in July. (Reporting by Aakash Jagadee...
Tags: Science, Fda, Bengaluru, Reuters, U S Food and Drug Administration, Jazz Pharmaceuticals Plc, Jazz Pharma, Supriya Roy, Aakash Jagadeesh Babu


New Postpartum Drug Is the Second Wholly Different Depression Treatment to be Approved This Month

New mothers suffering from postpartum depression finally have a treatment approved specifically for them. It’s the second drug this month approved by the Food and Drug Administration to address depression in a dramatically different way. But the treatment won’t come without serious restrictions on its use, nor will it…Read more...
Tags: Science, Drugs, Mental Health, Depression, Food And Drug Administration, Fda, Postpartum Depression


New Postpartum Drug Offers a Wholly Different Approach to Treating Depression

New mothers suffering from postpartum depression finally have a treatment approved specifically for them. It’s the second drug this month approved by the Food and Drug Administration to address depression in a dramatically different way. But the treatment won’t come without serious restrictions on its use, nor will it…Read more...
Tags: Science, Drugs, Mental Health, Depression, Food And Drug Administration, Fda, Postpartum Depression


I Suffered from Severe IBS for 18 Years till One Treatment Changed Everything

Nearly 16 million Americans suffer from IBS-D, or irritable bowel syndrome with diarrhea. Dawn Cobb suffered for almost two decades and thought surgery was her only hope—until a new FDA approved treatment changed everything.
Tags: Science, Fda, IBS, Dawn Cobb


San Francisco Wants to Ban All E-Cigarette Sales

The city of San Francisco has proposed a new ban on all e-cigarettes that haven’t been approved by the FDA from being sold in the city. The catch? No e-cigarette has been approved by the FDA.Read more...
Tags: Health, Science, Smoking, San Francisco, Food And Drug Administration, Fda, Nicotine, Vaping, E Cigarettes, Flavored E Cigarettes, Youth Vaping


Roche's Tecentriq Gets FDA Approval for Difficult Lung Cancer

Roche (RHHBY) gets an FDA approval of sBLA for Tecentriq in combination with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).
Tags: Science, Fda, Roche, Roche RHHBY


FDA puts partial hold on clinical trials of AbbVie's cancer drug

AbbVie Inc said on Tuesday the U.S. Food and Drug Administration placed a partial clinical hold on all trials of its cancer treatment Venclexta for multiple myeloma. The clinical hold does not impact any of the approved indications for Venclexta, such as chronic lymphocytic leukemia (CLL) or acute myeloid leukemia (AML), and is limited to investigational clinical trials in multiple myeloma, AbbVie said.
Tags: Science, Fda, Abbvie, U S Food and Drug Administration, AML, AbbVie Inc


Drinking Sugary Beverages Linked with Early Death

Soda and other sugary beverages aren't exactly known for being healthy. But now, a new study finds that sugar-sweetened beverages are tied to an increased risk of early death.In the study, published today (March 18) in the journal Circulation, researchers analyzed information from more than 80,000 women and 37,000 men in the health profession who were followed for about three decades. Participants filled out surveys about their diet every four years, and also answered questions about their l...
Tags: Science, Fda, SSB, Real Food, Walter Willett, Vasanti Malik


The Great Final Battle Over Your Juul Has Begun

Despite the announcement of Scott Gottlieb’s sudden resignation from the Food and Drug Administration earlier this month, the FDA commissioner said he remains confident that tighter regulation of the e-cigarette and tobacco industries following his departure will continue. And that means Juul isn’t off the hook just…Read more...
Tags: Science, Smoking, Food And Drug Administration, Fda, Juul, Altria, Scott Gottlieb, Juuling, Vapelife


Atossa Genetics News: FDA Approval Sends ATOS Stock Skyrocketing

Atossa Genetics news about it getting approval from the U.S. Food and Drug Administration (FDA) for one its its drugs has its stock soaring.Source: Shutterstock Atossa Genetics (NASDAQ:ATOS) has announced that its breast cancer drug Endoxifen has been given special approval by the FDA. This approval is for using the drug to treat a specific patient under the organization's expanded access program.This Atossa Genetics news has the company using Endoxifen as a "post-mastectomy treatment in a p...
Tags: Usa, Science, Fda, Steven, William White, U S Food and Drug Administration FDA, ATO, InvestorPlace, Atossa Genetics, Atossa Genetics News, Shutterstock Atossa Genetics NASDAQ, Endoxifen


Biotech Stock Roundup: REGN Gets FDA Nod for Dupixent & Other Pipeline News

Key highlights of the past week are regulatory and pipeline developments.
Tags: Science, Fda


FDA approves new valsartan generic to counter shortages of the blood pressure drug

The FDA approved a new generic version of valsartan to address the drug's shortage.
Tags: Science, Fda


FDA approves generic valsartan amid drug shortage

(Reuters) - The U.S. Food and Drug Administration on Tuesday approved a new generic of heart medicine valsartan and said it prioritized the drug's review to help relieve recent shortage as manufacturers around the world have pulled the treatment from market. Several drugmakers, including Teva Pharmaceutical Industries Ltd and Mylan NV, have recalled batches of valsartan as the drugs have been found to contain probable carcinogens. The approval of the generic, Diovan, was granted to Alkem Lab...
Tags: Science, Fda, Reuters, U S Food and Drug Administration, Teva Pharmaceutical Industries Ltd, Mylan NV, Alkem Laboratories Ltd


National Cancer Institute chief to serve as acting FDA head

Sharpless, who has led the National Institutes of Health's cancer unit since 2017, will take over following Gottlieb's exit in April, the U.S. Department of Health and Human Services said on Tuesday. Cancer experts and advocates praised the appointment of Sharpless as acting FDA chief after Gottlieb's abrupt resignation earlier this month.
Tags: Science, National Institutes of Health, Fda, U S Department of Health and Human Services, National Cancer Institute, Sharpless, Gottlieb


The New Interim Head of the FDA Seems Mercifully Normal

Scott Gottlieb’s immediate replacement as head of the Food and Drug Administration will be Norman “Ned” Sharpless, the current director of the National Cancer Institute, according to Health and Human Services Secretary Alex Azar. Sharpless will serve as the FDA’s interim chief once Gottlieb departs in less than a…Read more...
Tags: Science, Food And Drug Administration, Fda, Health And Human Services, National Cancer Institute, Gottlieb, Scott Gottlieb, Norman `` Ned '' Sharpless, Ned Sharpless, Alex Azar Sharpless


Roche's (RHHBY) Tecentriq Gets FDA Approval for Breast Cancer

Roche (RHHBY) gets FDA approval for immuno-oncology drug, Tecentriq in combination with Abraxane for the treatment of breast cancer.
Tags: Science, Fda, Roche, Abraxane, Roche RHHBY


FDA approves Pfizer's biosimilar to Roche's Herceptin

The U.S. Food and Drug Administration said on Monday it approved Pfizer Inc's biosimilar to Roche AG's blockbuster breast cancer treatment Herceptin. The approval comes nearly a year after the agency declined to approve the drug, Trazimera, and sought additional technical information. Since then, the FDA has approved a biosimilar to Herceptin from Celltrion Inc, and one developed by Samsung Bioepis Co Ltd, a joint venture between Samsung BioLogics and Biogen Inc. The FDA has also approved Myl...
Tags: Science, Fda, Pfizer, Mylan, U S Food and Drug Administration, Roche, Pfizer Inc, Biogen Inc, Samsung BioLogics, Roche AG, Celltrion Inc, Samsung Bioepis Co Ltd, Herceptin


FDA Lifts Import Ban on Genetically Modified Salmon That Reach Market Twice as Fast

The Food and Drug Administration announced on Friday that it is lifting an import ban that prevented a brand of genetically modified salmon—dubbed “Frankenfish” by some—from reaching U.S. shopping selves, CNN reported.Read more...
Tags: Food, Science, Usda, Cnn, Fish, Salmon, Genetics, Agriculture, Food And Drug Administration, Fishing, Genetically Modified Organisms, Gmos, Fda, Fisheries


Roche's Tecentriq notches win in breast cancer with U.S. approval

The U.S. Food and Drug Administration (FDA) approved Tecentriq mixed with the chemotherapy Abraxane to treat inoperable, locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, a protein that may help cancers avoid detection by the immune system. Roughly 40 percent of the patients in Roche's study had tumors with high PD-L1 levels. The FDA's OK was based on a trial that showed the drug cocktail helped stave off the disease's advance by a median...
Tags: Science, Fda, Basel, U S Food and Drug Administration FDA, Roche, TNBC, Abraxane


How Is Taking Ketamine for Depression Different From Falling Into a K-Hole?

You’ve probably heard a lot about ketamine this week, thanks to the Food and Drug Administration’s decision to approve a nasal spray based on the drug as a new depression treatment. But given ketamine’s long-standing reputation as a recreational drug—so notorious that users talk about entering a “K-hole” after taking…Read more...
Tags: Science, Brain, Depression, Food And Drug Administration, Fda, Ketamine, Spravato


FDA finds asbestos in three Claire's cosmetics products

The FDA said it would work with Congress to update the regulatory framework that the agency has been operating under for more than 80 years for cosmetics. In its safety alert, the FDA identified the products as Claire's eye shadows, contour palette and compact powder and cited the talc used in the products. Claire’s disputed the FDA test results, saying they “show significant errors” and have “mischaracterized fibers in the products as asbestos.” The retailer, which emerged from bankruptcy in...
Tags: Science, Congress, Fda, Reuters, Johnson Johnson, Claire


Ketamine Is Now an FDA-Approved Depression Treatment, but Who Will Be Able to Get It?

This week, the Food and Drug Administration approved Johnson & Johnson’s Spravato, the nasal spray version of a ketamine-like sedative, for certain cases of depression. And the drug is already being heralded as a “game-changer” for depression and suicide treatment. But chief among the major questions the average…Read more...
Tags: Science, Depression, Food And Drug Administration, Fda, Ketamine, Johnson Johnson, Spravato


U.S. FDA chief tough on e-cigarettes steps down abruptly

Gottlieb was well regarded by public health advocates and won bipartisan support for his efforts to curb use of flavored e-cigarettes by youths, speed approval times for cheap generic medicines to increase competition and bring down drug prices, and boost the use of cheaper versions of expensive biotech medicines called biosimilars. Unlike his predecessors, who said drug pricing was not the purview of the FDA, Gottlieb waded into the intensifying debate about the high cost of medicines for U.S....
Tags: Science, Fda, Scott, Gottlieb, Health and Human Services HHS, FDA Gottlieb, Alex Azar


U.S. FDA chief tough on e-cigs steps down in surprise resignation

Gottlieb was well regarded by public health advocates and won bipartisan support for his efforts to curb use of flavored e-cigarettes by youths, speed approval times for cheap generic medicines to increase competition and bring down drug prices, and boost the use of cheaper versions of expensive biotech medicines called biosimilars. Unlike his predecessors, who said drug pricing was not the purview of the FDA, Gottlieb waded into the intensifying debate about the high cost of medicines for U.S....
Tags: Science, Fda, Scott, Gottlieb, Health and Human Services HHS, FDA Gottlieb, Alex Azar


Over half of ED visits for nonmedical prescription drug use are patients under 35

Using nationally representative public health surveillance data to characterize US ED visits for harm caused by nonmedical prescription drug use, investigators at CDC and FDA report in the American Journal of Preventive Medicine that over half these visits are by young adults under 35, and over 40 percent of patients arrive unconscious or after cardiorespiratory failure. They include recommendations to guide prevention efforts.
Tags: Science, Cdc, US, Fda, American Journal of Preventive Medicine


A Ketamine-Based Nasal Spray Is Now an FDA-Approved Depression Treatment

The U.S. Food and Drug Administration has approved the first new kind of depression treatment seen in decades, a nasal spray drug based on the sedative ketamine.Read more...
Tags: Science, Drugs, Depression, Fda, Ketamine, U S Food and Drug Administration, Johnson Johnson, Spravato


FDA chief tough on e-cigs steps down in surprise resignation

Gottlieb was well regarded by public health advocates and won bipartisan support for his efforts to curb use of flavored e-cigarettes by youths, speed approval times for cheap generic medicines to increase competition and bring down drug prices, and boost the use of cheaper versions of expensive biotech medicines called biosimilars. Unlike his predecessors, who said drug pricing was not the purview of the FDA, Gottlieb waded into the intensifying debate about the high cost of medicines for U.S....
Tags: Science, Fda, Scott, Gottlieb, Health and Human Services HHS, FDA Gottlieb, Alex Azar


FDA Chief Scott Gottlieb Abruptly Resigns

In what might be one of the most surprising departures from the Trump administration yet, Scott Gottlieb has tendered his resignation as commissioner of the Food and Drug Administration, effective next month. The abrupt decision, initially reported by the Washington Post on Tuesday, comes in the middle of several…Read more...
Tags: Science, Washington Post, Food And Drug Administration, Fda, Trump, Resignation, Scott Gottlieb



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