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MDMA For PTSD Therapy Enters Final Round of Trials, Could Be Approved In U.S. and Canada By 2021

5 hours agoNews : Newsweek: US

This comes after the Food and Drug Administration designated MDMA as a "breakthrough therapy."

Honduran congressman indicted in US for drug trafficking

A Honduran legislator has been charged in a U.S. federal court with participating in a drug trafficking conspiracy and related weapons offenses. The U.S. Drug Enforcement Administration says in a … Click to Continue »

Panera petitions the U.S. to finally define “egg”

On Thursday, Panera petitioned the Food and Drug Administration to more precisely define what constitutes an egg. “They actually define a bunch of related terms like dried egg whites, freeze dried egg yolks, all these other related terms,...Show More Summary

FDA plans more restrictive policy for bulk drug compounding

(Reuters) - The head of the U.S. Food and Drug Administration on Thursday said it is preparing a new, more restrictive policy targeting what drugs compounding pharmacies can produce that do not go through the agency's approval proce...

Enzyme.io wants to make FDA compliance easier for startups

The Food and Drug Administration approval process can be like navigating a landmine for health startups hoping to get through regulations and begin selling to the American public. YC company Enzym.io hopes to help these small businesses out by automating the process for them. Show More Summary

This ice cream is being recalled due to listeria risks. Check to see if your favorite brand is affected.

According to the U.S. Food and Drug Administration, popular ice cream bars are being recalled from numerous stores around the country. Kroger, Aldi, Winn-Dixie, BJ's, ShopRite, Stop N Shop, and even the Dollar Tree, are all sending back ice cream that may cause listeria. ??? Read more... Permalink | Email this | Linking Blogs | Comments

U.S. court invalidates J&J cancer drug patent, hitting UK's BTG

NEW YORK (Reuters) - A U.S. administrative court invalidated a Johnson & Johnson patent on its blockbuster prostate cancer drug Zytiga, bringing rivals closer to selling generic versions and hitting shares in its British partner BTG Plc.

U.S. court invalidates patent on J&J cancer drug Zytiga

NEW YORK (Reuters) - A U.S. administrative court on Wednesday invalidated a Johnson & Johnson patent on its blockbuster prostate cancer drug Zytiga, bringing rivals closer to selling generic versions.

New report calls into question effectiveness of pregnancy anti-nausea drug

(St. Michael's Hospital) Previously unpublished information from the clinical trial that the US Food and Drug Administration relied on to approve the most commonly prescribed medicine for nausea in pregnancy indicates the drug is not effective, a new report says.

Documents: DEA agents shot suspect who drove at them

Court documents show a Drug Enforcement Administration agent shot a suspect who drove at the agent during a sting in California. KBAK-TV reports the shooting happened Jan. 11 in a … Click to Continue »

Novartis gets U.S. priority review for Kymriah for adults with lymphoma

ZURICH (Reuters) - Novartis has been ?granted priority review for its cell therapy Kymriah for adults with a form of lymphoma by the U.S. Food and Drug Administration, the Swiss drugmaker said on Wednesday, as it seeks to expand use of the treatment in multiple blood cancers.

FDA expects IV fluid shortage to improve in coming weeks, months

(Reuters) - The U.S. Food and Drug Administration said on Tuesday it expects a shortage of intravenous saline fluids for hospitals due to damage to key manufacturing facilities in Puerto Rico to improve over the coming weeks and mon...

Having a Pharmacist at Stroke Patient's Bedside Speeds Administration of Critical Drug

In treating stroke patients, every minute counts. A drug called rtPA sometimes can stop a stroke in its tracks. Now a Loyola Medicine study has found that having a pharmacist at the patient's bedside can reduce the time it takes to administer rtPA by a median of 23.5 minutes.

FDA to speed review of medical products for use by military

(Reuters) - The U.S. Food and Drug Administration and Department of Defense launched a program on Tuesday to speed the development and review of medical products needed by the military, such as freeze-dried plasma that could prevent wounded troops from bleeding to death.

Insurance company requirements place heavy administrative burden on physicians seeking to prescribe new cholesterol-lowering drugs

(University of Pennsylvania School of Medicine) A rare glimpse into the prior authorization requirements implemented by public and private insurance providers across the country has found substantial administrative burden for a new class of medications for patients with high cholesterol that places them at high risk for heart attack or stroke, according to new research.

FDA to speed review of medical products used by military

(Reuters) - The U.S. Food and Drug Administration and Department of Defense launched a program on Tuesday to speed up the development of drugs that could be used by military personnel.

Insurance Company Requirements Place Heavy Administrative Burden on Physicians Seeking to Prescribe New Cholesterol-Lowering Drugs

A rare glimpse into the prior authorization requirements implemented by public and private insurance providers across the country has found substantial administrative burden for a new class of medications for patients with high cholesterol that places them at high risk for heart attack or stroke. Show More Summary

US OKs 1st drug aimed at women with inherited breast cancer

U.S. regulators have approved the first drug aimed at women with advanced breast cancers caused by an inherited flawed gene. The Food and Drug Administration on Friday approved AstraZeneca PLC's Lynparza … Click to Continue »

First treatment approved for breast cancer with BRCA genetic mutation

The Food and Drug Administration on Friday cleared the first treatment for patients with advanced breast cancer caused by BRCA mutations, which are genetic defects that raise the risk of malignancies. The drug, called Lynparza, already is approved for certain patients with advanced ovarian cancer...

FDA approves expanded use of AstraZeneca cancer drug

(Reuters) - The U.S. Food and Drug Administration said on Friday it has approved expanded use of AstraZeneca Plc's cancer drug Lynparza to include patients with metastatic breast cancer whose disease is associated with a mutation of the BRCA gene.

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