Regulations

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FDA rebuff for Keytruda in breast cancer indication

By Jane Byrne

A couple of new developments to report in relation to Merck, known as MSD outside the US and Canada: the first being the rejection by the US FDA of the company’s application to use its anti-PD-1 therapy, Keytruda, in certain breast cancer patients.

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Latest FDA COVID-19 updates and activity

By Jenni Spinner

The federal agency continues to keep researchers, pharma firms and citizens apprised of current happenings and research related to the virus and pandemic.

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First FDA COVID-19 update of 2021

By Jenni Spinner

As healthcare providers and other high-priority patients begin receiving the vaccines, the agency continues to act to help the national pandemic response.

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Advarra acquires Longboat

By Jenni Spinner

The clinical site services provider continues its series of strategic company purchases by bringing the Irish trial technologies firm under its umbrella.

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FDA grants EUA for combo COVID-19 treatment

By Jenni Spinner

The agency has given the go-ahead for use of baricitinib in conjunction with remdesivir for treating patients hospitalized with severe cases of the virus.

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FDA COVID-19 news roundup this week

By Jenni Spinner

The federal agency has offered updates, advice and action regarding the COVID-19 pandemic, helping life-sciences professionals stay on top of developments.

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Latest FDA updates on COVID-19 battle

By Jenni Spinner

As the pandemic maintains a grip on the globe, the federal agency continues to offer advice and take action to guide life-sciences professionals.

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FDA okays first COVID-19 treatment

By Jenni Spinner

The agency has approved the antiviral drug Veklury (remdesivir), produced by Gilead, for hospitalized patients 12 years and over diagnosed with the virus.

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CPhI Festival of Pharma

CPhI Pharma Awards recognize industry achievements

By Jenni Spinner

The 17th annual awards program, announced during the CPhI Festival of Pharma virtual event, hails professionals from various aspects of the industry.

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FDA COVID-19 response roundup

By Jenni Spinner

As the pandemic maintains its hold, the US agency continues to issue advice and take action related to testing, treatment and information on the virus.

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Trump and COVID-19: treatments to date

By Jenni Spinner

With the virus reaching the Oval Office, the presidential diagnosis is shining a spotlight on some of the drugs reportedly administered to the POTUS.

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Breaking FDA COVID-19 news

By Jenni Spinner

The agency continues to take actions and issue advice related to COVID-19 treatments, tests, consumer products and other pressing industry concerns.

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PRA: get ready for the RACE Act

By Jenni Spinner

Experts from the CRO offers insight on preparing for the changes to the pediatric oncology research requirements, which take effect next week.

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This week’s FDA COVID-19 updates

By Jenni Spinner

The US agency continues releasing resources, offering advice and taking actions related to the pandemic, and how life-sciences professionals respond.

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Weekly FDA COVID-19 updates and actions

By Jenni Spinner

The agency continues to offer advice to pharma industry professionals during the global public health crisis, and offer advice on developing solutions.

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This week’s FDA COVID-19 updates

By Jenni Spinner

The US agency continues to issue advice, offer guidance and take action related to the virus behind the global pandemic.

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FDA COVID-19 updates for the week

By Jenni Spinner

The federal agency continues to aid drug developers, trial teams and the public with advice and actions related to the virus behind the global pandemic.

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Newest FDA actions and alerts on COVID-19

By Jenni Spinner

The federal agency continues to monitor as the virus impacts the pharma and clinical trials industries, offering advice and taking action where necessary.