The pharmacy company's Wegovy (semaglutide) is the first therapy designated for chronic weight management that the agency has granted approval since 2014.
The Digital Health Measurement Collaborative Community is bringing together stakeholders to improve approaches and technologies in research and healthcare.
The University of Kansas Cancer Center has joined with trial tech provider Complion to develop a shared investigator platform for use in a range of studies.
The online pharma event will address the COVID-19 pandemic’s impact on the industry (and vice versa) and innovation in the face of formidable challenges.
June 2021 marks the 40th anniversary of the publication of the first reported cases of AIDS in the US. A session at BIO Digital – featuring Dr. Anthony Fauci, Director of NIAID at the NIH – will focus on four decades of innovation as well as the critical...
Acting FDA commissioner Janet Woodcock explains how government, researchers, doctors and patients can contribute to improving the clinical research system.
The virtual event (scheduled June 22-24) will feature presentations from Bayer, Merck, GSK, Novartis, Takeda, FDA, WHO, and other notable organizations.
The US agency continues to keep a watchful eye over the nation’s pandemic response, issuing advice to professionals and taking action where appropriate.
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.
A US court’s recent decision to find in favor of Sanofi and invalidate Amgen's broad antibody patent claims has biotech manufacturers concerned about how to preserve their IP.
As the vaccine goes into the arms of more people around the country, the US agency keeps on top of issues around the virus, offering resources and guidance.
The CRO will receive funding to fuel a five-year Research Project Award, with the goal to design and conduct research of potential PTSD treatment options.
The annual event, moved to the virtual realm thanks to COVID-19, offers content on remote monitoring, drug development technology and other key topics.
The US Food and Drug Administration (FDA) has issued guidance for companies developing vaccines, diagnostics and therapeutics against new variants of SARS-CoV-2.
Quotient Sciences, a drug development and manufacturing accelerator with facilities in the UK and the US, has acquired Arcinova, a UK-based multiservice contract development and manufacturing organization (CDMO).
The federal agency continues to keep researchers, pharma firms and citizens apprised of current happenings and research related to the virus and pandemic.
The company’s medical imaging technology and other eClinical solutions reportedly played a part in half of the treatments to receive the FDA designation.
As the COVID-19 vaccines continue the early stages of circulation in the US, the agency keeps an eye on industry actions and offers advice to key players.
A leader from the anti-counterfeit solutions firm says that while packaging-level efforts may have an effect, on-dose technology is worth a closer look.
Fight the Fakes gathers manufacturers and other stakeholders to brainstorm on ways to combat falsified medicines and safeguard the world’s medicine supply.
As healthcare providers and other high-priority patients begin receiving the vaccines, the agency continues to act to help the national pandemic response.
The head of the CRO’s Global Center of Excellence for Decentralized Clinical Trial Strategy outlines key developments in 2020, and keys to success in 2021.
The new EU Pharmaceutical Strategy, adopted today by the European Commission, is designed to improve and accelerate patients’ access to safe and affordable medicines and address unmet medical needs in the areas of antimicrobial resistance, cancer, and...
The clinical site services provider continues its series of strategic company purchases by bringing the Irish trial technologies firm under its umbrella.
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.
The federal agency has offered updates, advice and action regarding the COVID-19 pandemic, helping life-sciences professionals stay on top of developments.
During a free editorial webinar on December 9, a panel of clinical trial experts will offer a range of insights into the future of research technology.
The agency has approved the antiviral drug Veklury (remdesivir), produced by Gilead, for hospitalized patients 12 years and over diagnosed with the virus.
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.
The agency continues to offer advice to pharma industry professionals during the global public health crisis, and offer advice on developing solutions.
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.
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.
The federal agency continues to monitor as the virus impacts the pharma and clinical trials industries, offering advice and taking action where necessary.