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FDA Panel Votes 12 To 4 to Approve Puma’s Breast Cancer Drug

A panel of experts convened by the Food and Drug Administration says that a drug for breast cancer developed by Puma Biotechnology should be approved, but argued for more limits on which women should get the medicine.

Exclusive: McConnell expects bipartisan support for bill reauthorizing FDA user fees

WASHINGTON (Reuters) - U.S. Senate Republican Leader Mitch McConnell told Reuters on Wednesday he expects bipartisan support for approval of a bill authorizing taxpayer and industry funding for the U.S. Food and Drug Administration.

Justice watchdog says agency botched deadly Honduras mission

Government watchdogs say the U.S. Drug Enforcement Administration misled Congress about an aggressive drug enforcement strategy that led to a series of deadly confrontations involving agents in Honduras. In a … Click to Continue »

The DEA Misled Congress About Deadly Shooting In Honduras

2 hours agoNews : Huffington Post

WASHINGTON — The Drug Enforcement Administration misled Congress about a 2012 shooting in Honduras that left four innocent people dead, including a 14-year-old boy, according to a new report from the Justice Department’s internal watchdog. A DEA agent in a helicopter gave an order to fire upon a passenger boat in Ahuas, Honduras, on May 11, 2012. Show More Summary

FDA panel backs Puma Biotech's breast cancer drug

3 hours agoHealth : Reuters: Health

(Reuters) - Puma Biotechnology's experimental breast cancer drug reduces the risk of the disease returning and should be approved, an advisory committee to the U.S. Food and Drug Administration concluded on Wednesday, paving the way for its approval in patients who have already had their tumors surgically removed.

Ron Paul On The Drug War: Will The Trump Administration OD On Authoritarianism?

Authored by Ron Paul via The Ron Paul Institute for Peace & Proseprity, Last week Attorney General Jeff Sessions ordered federal prosecutors in drug cases to seek the maximum penalty authorized by federal mandatory minimum sentencing laws. Show More Summary

White House walks back earlier proposal to gut drug czar’s office

23 hours agoNews : NY Daily News

The Trump administration walked back an earlier budget proposal to gut roughly 95% of the department’s funding.

FDA clears Merck's Keytruda for cancer patients with certain biomarkers

23 hours agoHealth : Reuters: Health

(Reuters) - The U.S. Food and Drug Administration on Tuesday approved Merck & Co's immuno-oncology treatment, Keytruda, for cancer patients who carry a specific genetic feature.

Regeneron, Sanofi rheumatoid arthritis drug wins U.S. approval

(Reuters) - The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals and Sanofi's biotech drug for adults with moderate to severe rheumatoid arthritis, the two companies said on Monday.

FDA staff finds Puma Biotech's cancer drug effective, shares soar

(Reuters) - Shares of Puma Biotechnology Inc surged about 80 percent on Monday after the U.S. Food and Drug Administration staffers concluded after a preliminary review that the company's experimental breast cancer drug was effectiv...

FDA warning letters target French, Portuguese companies

A French company that packs olives and garlic and a sardine packer in Portugal are both on notice from the Food and Drug Administration for food safety violations at their facilities. In warning letters dated May 5 and recently made public by FDA, the agency outlined violations and gave the companies 15 working days to... Continue Reading

American College of Rheumatology Responds to FDA Draft Guidance on Biosimilar Interchangeability

Today, the American College of Rheumatology submitted comments to the U.S. Food and Drug Administration concerning the draft guidance, 'Considerations in Demonstrating Interchangeability with a Reference Product' (FDA 2017-01042).'

Tillerson: US must deal with demand to stem drug violence

5 days agoNews : The Cutline

WASHINGTON (AP) — Two top Trump administration officials said Thursday that Americans' demand for illicit narcotics is fueling violence in Mexico and must be reduced if cross-border security issues are to be addressed.

Second Drug Receives FDA Approval for Bladder Cancer Based on Research Led by NYU Langone

The U.S. Food and Drug Administration has granted accelerated approval to a second drug in less than a month for first-line treatment for advanced bladder cancer - again based on clinical trial findings from the same researcher from NYU Langone's Perlmutter Cancer Center.

Bayer gets FDA priority review for blood cancer drug

FRANKFURT, Germany (Reuters) - German drugmaker Bayer won the U.S. Food and Drug Administration's priority review status for an experimental drug for a difficult to treat type of blood cancer, bolstering its development pipeline.

Peace, Drugs, and Tough Love for Colombia’s Santos in Washington

With coca production rising, Venezuela melting down next door, and a Trump administration ambivalent about a peace deal with the FARC, the embattled Colombian president has a lot on his plate.

New FDA commissioner reassigns inspectors by specialty

New Food and Drug Administration Commissioner Scott Gottlieb is reassigning inspectors based on what they inspect instead of where they inspect it, as has been the plan for four years. It does not mean any change in the 4,000 inspectors assigned by FDA to inspect domestic and foreign facilities or to respond to consumer complaints.... Continue Reading

2017 FDA Science Forum May 31-June 1: Explore cutting-edge research, free admission

(U.S. Food & Drug Administration) Join thought leaders from the scientific community and FDA scientists as they present their cutting-edge work at FDA's White Oak Campus in Silver Spring, MD. FDA experts highlight the science conducted at the Agency and demonstrate how FDA's research informs our regulatory decision-making and scientific activities. Show More Summary

US senators from both parties try to ease banking for marijuana businesses

6 days agoNews : The Raw Story

Republican and Democratic senators on Wednesday renewed their drive to make banking easier for marijuana-based businesses in those U.S. states where the drug is legal, undeterred by signals from the Trump administration about maintaining tough marijuana restrictions nationally. The eight senators,...

The impact of the rise in new drug rejections

The number of new drug applications rejected by the U.S. Food and Drug Administration has been on the rise. The cover story of Chemical & Engineering News (C&EN), the weekly newsmagazine of the American Chemical Society, explores why this is happening and what it means for patients.

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