Regulations

WuXi AppTec: think ahead when dual-filing IND applications

20-Oct-2020 By Jenni Spinner

A leader from the company advises planning ahead when filing investigational new drug applications to avoid wasting time, work and money later.

CPhI Festival of Pharma

CPhI Pharma Awards recognize industry achievements

19-Oct-2020 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.

ATCC lands $250m from BARDA for COVID-19 services

06-Oct-2020 By Jenni Spinner

The contract, with a ceiling value of $250M and potential length of 10 years, will supplement the company’s ongoing support of virus-related work.

FDA COVID-19 response roundup

05-Oct-2020 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.

Trump and COVID-19: treatments to date

05-Oct-2020 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.

Breaking FDA COVID-19 news

26-Aug-2020 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.

Potential HIV cure Phase I trial gets FDA green light

11-Aug-2020 By Jenni Spinner

American Gene Technologies has received the agency’s approval to launch the first human trial for its lead HIV program, starting in Baltimore and DC.

PRA: get ready for the RACE Act

10-Aug-2020 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.

This week’s FDA COVID-19 updates

23-Jul-2020 By Jenni Spinner

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

Weekly FDA COVID-19 updates and actions

08-Jul-2020 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.

FDA approves ViiV Healthcare’s HIV treatment

07-Jul-2020 By Jenni Spinner

The agency has given the thumbs up for Rukobia, a treatment designed for HIV patients facing poor results with current antiretroviral therapies.

This week’s FDA COVID-19 updates

25-Jun-2020 By Jenni Spinner

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

FDA advises API makers on COVID-19 safe practices

24-Jun-2020 By Jenni Spinner

The agency's latest guidance offers advice on keeping manufacturing of active pharmaceutical ingredients safe during the COVID-19 pandemic.

Gilead gets green light for inhaled remdesivir study

23-Jun-2020 By Jenni Spinner

After receiving FDA approval, the pharmaceutical company has announced plans to launch a Phase I trial for an inhaled version of the COVID-19 treatment.

FDA COVID-19 updates for the week

18-Jun-2020 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.