Rutgers' RUCDR Infinite Biologics received an amended emergency use authorization from the FDA late Thursday for the first SARS-CoV-2 coronavirus test that will allow people to collect their own saliva at home and send to a lab for results.

The Dahme-Spreewald administrative district’s local building inspection authority confirmed the completion of the passenger terminal (Terminal 1) at BER following completion of the construction work.

Several studies have been published evaluating the impact of 2011 Accreditation Council for Graduate Medical Education duty hour regulations. Although resident quality of life may be improved, it appears that resident education and patient care may be worse.

This is the first study to evaluate pediatric program director approval of 2011 Accreditation Council for Graduate Medical Education Common Program Requirements and the perceived impact of the regulations on patient care, resident education, and quality of life. (Read the full article)

Medical devices approved for adults can be used to treat children despite the lack of rigorous evidence. In 2007, Congress passed the Pediatric Medical Device Safety and Improvement Act to stimulate pediatric device development.

Most pediatric devices approved since the legislative change have had limited premarket study in children, with pediatric patients representing <10% of trial participants. Postmarketing studies required by the US Food and Drug Administration also yielded limited additional pediatric data. (Read the full article)

The U.S. Education Department says the states need more evidence to use the popular admissions test to measure high school achievement.

The U.S. Department of Education continues to quietly approve and negotiate over states' teacher-evaluation systems as part of its No Child Left Behind Act waiver process.

The Dahme-Spreewald administrative district’s local building inspection authority confirmed the completion of Terminal T1 at BER on 28 April following the completion of the construction work.

The Delaware Department of Agriculture announced today that the USDA approved the state plan submitted for the Delaware Domestic Hemp Production Program. Delaware is now the second state on the East Coast to receive approval to administer a domestic hemp program.

On June 20, Gov. John Carney signed enabling legislation (House Bill 193) moving Delaware a step closer to a reinsurance program beginning in 2020. NEW CASTLE (Aug. 20, 2019) – The Department of Health and Social Services (DHSS) received approval today from the Centers for Medicare and Medicaid Services (CMS) for a 1332 State Innovation […]

RBI grants In-principle Approval to 10 Small Finance Banks

VÉLIZY-VILLACOUBLAY, France and NEW YORK — August 19, 2019 – Dassault Systèmes SE (Dassault Systèmes) (Euronext Paris: #13065, DSY. PA) and Medidata Solutions, Inc. ("Medidata") (NASDAQ: MDSO) announced that Medidata stockholders have approved on August 16, 2019 the proposed acquisition of Medidata by Dassault Systèmes. At a special meeting of Medidata stockholders held on August 16, 2019, 78% of Medidata’s total outstanding common stock voted in favor of the proposed acquisition and...

On Monday, Duke Energy announced a proposal to make what it says is the largest investment in electric vehicle (EV) infrastructure ever in the Southeast – a $76 million initiative to spur EV adoption across the state.

Genex Power Limited has secured all environmental approvals required to develop the 250-MW Kidston Pumped Storage Hydro Project (K2-Hydro).

This week, Duke Energy announced that regulators have approved two projects involving energy storage worth about $30 million.

Solar Wind Energy Tower Inc. won approval from an Arizona city to develop a $1.5 billion project that would use ambient desert heat to create a draft to generate electricity, in a concrete colossus that would be the tallest structure in North America.

The approval rating of the Moon Jae-in government has hit a low of 67.1 percent largely due to North Korea nuclear issues. The rating has fallen for three consecutive weeks. As for the approval rating of the ruling Minjoo Party has declined for four weeks in a row to 49.3 percent. Pollster Realmeter said on September 18 that a survey commissioned by CBS-TV revealed that the ratio of those who thought positively about the way the current government has performed was 67.1 percent, down by 2.0 p...

A US regulator on Thursday pulled approval for dozens of companies making industry-standard masks in China, citing substandard performance, and warned health care providers to reconsider using any of the now-blacklisted products.After the US Food and Drug Administration’s determination that many of the made-in-China N95-style masks filter out less than 95 per cent of particulate matter – the filtration level that gives the N95 mask its name – the approved number of manufacturers dropped to 14…

President Moon Jae-in's approval rating has stood at over 60 percent for a third week running despite the dire state of the economy.Moon, who marks his third year in office this weekend, seems to owe his recovered popularity to the relatively smooth handling of the coronavirus epidemic. But it also ...

Japan has fast-tracked the approval of the anti-viral drug remdesivir to be used to treat COVID-19 patients in that country.Speaking to reporters Friday in Tokyo, Japanese Chief Cabinet Secretary Yoshihide Suga confirmed the rare fast-track, four-day approval of remdesivir by the Ministry of Health,...

* LILLY RECEIVES U.S. FDA APPROVAL FOR RETEVMO™ (SELPERCATINIB), THE FIRST THERAPY SPECIFICALLY FOR PATIENTS WITH ADVANCED RET-DRIVEN LUNG AND THYROID CANCERS

Title: Prostate Cancer Vaccine May Get FDA Approval
Category: Health News
Created: 4/27/2010 8:10:00 AM
Last Editorial Review: 4/27/2010 12:00:00 AM

Title: FDA Panel Urges Approval of Hepatitis C Drug
Category: Health News
Created: 4/28/2011 11:01:00 AM
Last Editorial Review: 4/28/2011 12:00:00 AM

Title: Afinitor Approval Expanded to Include Benign Kidney Tumors
Category: Health News
Created: 4/27/2012 2:05:00 PM
Last Editorial Review: 4/30/2012 12:00:00 AM

• France Galop lobbied Emmanuel Macron for go-ahead
• Longchamp one of three meetings to take place on Monday

France Galop, the ruling body of French racing, confirmed on Saturday it will resume with meetings at Longchamp, Toulouse and Compiegne on Monday, but only after what is believed to have been urgent behind-the-scenes lobbying by Edouard de Rothschild, FG’s president, late on Friday night that persuaded Emmanuel Macron, the French president, to finally give his approval to the resumption.

De Rothschild thanked Macron and Édouard Philippe, France’s prime minister, for their efforts in a tweet in the early hours of Saturday morning that confirmed racing had seen off last-minute objections to its return.

New surveys out Thursday show President Donald Trump’s approval rating for his handling of the coronavirus pandemic is underwater in four critical states while governors receive high marks.

Environmental Working Group has launched EWG Verified, a label that will help consumers spot products that meet stringent ingredient and transparency requirements

It may soon be easier for shoppers to find beauty products without toxic chemicals. The Environmental Working Group nonprofit launched a new label this month called EWG Verified, which certifies personal care products as free from chemicals of concern.

The program is an extension of the group’s work with the Skin Deep database, which for more than a decade now has given tens of millions of visitors information on the chemical contents and relative safety of their favorite cosmetics and shampoos.

Before the pill was approved by the FDA on May 9, 1960, there were few contraceptive options available to young women. It revolutionized family planning and the sex lives of millions of Americans.

The number of home loans issued in Australia rose 1.5 per cent in February, but still fell short of forecasts.

NRL clubs will be able to resume training from May 4 as the competition charges towards its planned restart three weeks later.

Roche’s antibody test for Covid-19 has been given the CE mark and has been issued Emergency Use Authorisation from the US Food and Drug Administration.

New era for lymphoma, leukemia, possibly other cancers

Agency moves toward more accelerated reviews

The approval gives NSCLC patients whose tumours carry the MET exon 14 skipping mutation a new treatment option

As cancer research reveals the genetic basis of the disease, pharmaceutical companies are pursuing targeted therapies that address certain groups of patients. One such drug from Novartis won FDA approval Wednesday, making it the first therapy cleared by the agency to treat patients whose non-small cell lung cancer (NSCLC) carries a certain genetic mutation. The […]

In this video explainer, Christopher Robertson discusses the Right to Try Act and off-label use of pharmaceuticals with Alison Bateman-House.

The post Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson appeared first on Bill of Health.

Sanofi’s MedQuadfi Meningococcal Conjugate Vaccine has scored FDA approval for the prevention of invasive meningococcal disease, becoming the first and only product available in the US for this indication in patients of at least two years old.

Novartis has revealed that the European Commission has moved to approve Cosentyx (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients.

The FDA has awarded marketing authorisation to Novartis for the Oral MET inhibitor Tabrecta for the first-line treatment of metastatic non-small cell lung cancer in patients whose tumors have a mutation that leads to MET exon 14 skipping (METex14), regardless of whether they have previously received any type of treatment.

Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and…

As had been widely expected, Gilead Sciences on Thursday announced that the Japanese Ministry of Health,…

AbbVie and Allergan have waited for nearly a year for their much-discussed merger to pass muster. Finally, after pushback from consumer groups and tight scrutiny from regulators, the FTC has granted its green light. The partners face just one final hurdle to consummating their deal. 

"I applaud the work of the Senate Judiciary Committee, particularly Chairman Leahy, Ranking Member Sessions and Senators Durbin and Graham, in taking such an important step toward reforming our sentencing laws. I look forward to the Senate and the House approving this legislation quickly so that it can be signed into law."

Today, the Departments of Justice and Interior applauded the final approval by U.S. Senior District Judge Thomas F. Hogan of Cobell v. Salazar, a long-running and contentious individual American Indian trust class-action lawsuit.

“This settlement allows the Department of Agriculture and African-American farmers to focus on the future, and brings us one step closer to giving these farmers a chance to have their claims heard,” said Attorney General Holder.

The Department of Justice, the Congress of Hispanic Educators (CHE) and the Denver Public Schools (DPS) have jointly requested court approval of a consent decree that requires that the more than 20,000 English Language Learner (ELL) students enrolled in DPS receive the services they need to overcome language barriers and meaningfully participate in school. The proposed consent decree will benefit all ELLs and LEP parents in the district, including not only the 87 percent of ELL students who are native Spanish speakers, but those who speak one of the 137 other languages spoken in the district as well.

Editor's note: This story was originally published Friday morning, and has been updated to reflect the FDA's decision regarding the drug later that day. A U.S. approval decision for a major drug planned to be marketed by Cambridge-based Sanofi Genzyme that had been expected last Friday has been delayed due to “deficiencies” found during a manufacturing site inspection in France. In its third quarter report, released Friday morning, French drugmaker Sanofi (NYSE: SNY) disclosed that “manufacturing…

The company receives approval for MenQuadfi to prevent meningococcal disease.