The US Food and Drug Administration continues to review potential preventatives and treatments for the virus, and to offer advice to life-sciences professionals and civilians alike.
This month’s roundup of equipment, decentralized technology, partnerships and other items includes news from Medidata, PerkinElmer, Syneos and other firms.
The US Food and Drug Administration has kept its staff busy with approvals, authorizations, and warnings related to various coronavirus-centered products.
The drug, intended for adult patients with moderate-to-severe systemic lupus erythematosus, is the only new therapy approved for SLE in more than a decade.
A leader from the topical solutions centered CDMO discusses the differences between approaches by the FDA and EMA, and how to deal with them effectively.
The BiovitalsHF, from Biofourmis, is intended to augment decision-making in clinical environments, and to supplement traditional pharmaceutical therapies.
US President Joe Biden singled out the pharmaceutical industry in his recently issued Executive Order on Promoting Competition in the American Economy.
The latest information coming from the agency includes news on drug shortages related to the virus, a drug-application milestone, a vaccine EUA, and more.
During the Rare/Orphan Diseases, Special Patient Population webinar, a group of industry experts discussed challenges and opportunities faced in the field.
The US federal agency has released a document designed to help clinical trial teams obtain effective, efficient data from patients in their cancer research.
Decentralized trials and remote monitoring, long discussed, but never really taking off until COVID-19 disrupted studies last year, will be under the spotlight at the DIA 2021 Annual Meeting at the end of this month.
The US agency’s latest actions and advice against the virus include information on test recalls, , approval and reauthorization of treatments, and more.
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 life-sciences data outfit has chosen former FDA principal deputy commissioner Amy Abernethy to serve as president of its clinical research business.
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.
The therapeutic has been approved as an adjuvant treatment for varieties of esophageal cancers in patients who have received neoadjuvant chemoradiotherapy.
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.
In this third part of a series on the state of clinical research, the acting FDA commissioner talks about possible pathways to improving the infrastructure.
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 leader from the CRO talks about increased use of electronic patient-reported outcomes in research, challenges of adoption, and how ePRO benefits trials.
The 6th annual Clinical Research as a Care Option conference, taking place April 26-27, brings together experts seeking solutions to elevate the industry.
A new report from the organization forecasts a wave of pharma innovation over the next four years could lead to 75 FDA drug approvals annually by 2025.
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 US Food and Drug Administration (FDA) has issued guidance for companies developing vaccines, diagnostics and therapeutics against new variants of SARS-CoV-2.
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.
The pharmaceutical firm reports a counterfeit version of its Symtuza HIV treatment has been found and pulled from shelves at three American pharmacies.
As healthcare providers and other high-priority patients begin receiving the vaccines, the agency continues to act to help the national pandemic response.
The company’s cancer drug, devimistat, has received orphan status from the agency for treating clear-cell sarcoma, pancreatic cancer, and other diseases.
As the pandemic continues to impact the globe, the agency has kept busy issuing EUAs for potential treatments, and cited sellers of unapproved treatments.
The division of the National Institutes of Health has begun enrolling hospitalized patients in a trial investigating various potential COVID-19 treatments.
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.
A leader from the global CRO talks about how use of RWE in clinical trials can benefit research sites and sponsors, and satisfy regulatory requirements.
