We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The U.S. government will pay Merck an estimated $1.2 billion for 1.7 million courses of its experimental COVID-19 antiviral, molnupiravir, if the drug is authorized by the FDA. Read More
The FDA is worried that Biogen may take too long to complete a required confirmatory trial for Aduhelm (aducanumab), the high profile Alzheimer’s disease drug that just this week scored a historic FDA approval amidst doubts about its clinical trial data and criticisms of the agency’s close collaboration with Biogen. Read More
Saying that the COVID-19 crisis “laid bare new and longstanding drug supply-chain vulnerabilities,” the Biden administration yesterday proposed sweeping changes for the U.S. drug industry to restore its control over drug ingredients and quality. Read More
Byondis, a Dutch biopharma company focused on oncology drugs, reported that its late-stage trial evaluating its antibody-drug conjugate candidate in HER2-positive breast cancer met its primary endpoint, a development that’s given it confidence to file for FDA approval by the end of the year. Read More
The FDA has granted Fast Track designation to BerGenBio’s Bemcentinib in combination with an anti-PD-(L)1 therapy for patients with AXL-positive advanced or metastatic nonsmall-cell lung cancer (NSCLC). Read More
The FDA has extended its review of Incyte’s Janus kinase (JAK) inhibitor Jakafi (ruxolitinib) for treating patients with steroid-refractory chronic graft-versus-host disease (GVHD). Read More
With a controversial bankruptcy settlement moving forward in the opioid lawsuit against Purdue Pharma, House Democrats and state attorneys general rallied Tuesday against the deal, calling for passage of legislation to ultimately hold its owners, the Sackler family, accountable. Read More