Johns Hopkins Carey Business School Senior Lecturer Supriya Munshaw – an expert in the commercialization of early-stage technologies, especially in the life science and medical device industries – offers her insights into the FDA’s rationale for approving the Alzheimer’s drug aducanumab, the price set by Biogen, the future of FDA leadership, and other related topics, in this Q&A.
The U.S. Food and Drug Administration has approved a new drug for treating schizophrenia and bipolar I disorder that includes samidorphan, a new chemical entity discovered at Rensselaer Polytechnic Institute.
Pediatric infectious disease expert David Cennimo is available to discuss the Food and Drug Administration approving Pfizer’s COVID-19 vaccine for emergency use on kids ages 12 to 15. “The Pfizer vaccine had a great track record of safety and success since…
A phase 3 clinical trial finds an anti-inflammatory drug used in rheumatoid arthritis can preserve lung function in patients with systemic sclerosis.
The University of Kansas Cancer Center is the first and only site in the region to offer CAR T-cell therapy to treat multiple myeloma, a type of blood cancer that affects about 30,000 people each year.
Pharmaceutical companies get special protection from the FDA for orphan drugs aimed at rare diseases, but a study shows high spending for common diseases for some such drugs. Just 21% of the total dollars spent in 2018 on 15 top-selling partial orphan drugs went to the treatment of rare diseases, while more than 70% went to the treatment of common diseases.
Seattle Cancer Care Alliance (SCCA), the only NCCN-designated cancer center in Washington State, has been selected as an authorized treatment center for the new chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel, also known as liso-cel and by the brand name BreyanziTM. Liso-cel was approved by the U.S. Food and Drug Administration (FDA) on February 5, 2021.
Alzheimer’s advocacy groups taint their credibility by not revealing conflicts when they lobby FDA for drug approval
An immunotherapy agent combined with a tyrosine kinase inhibitor drug whose clinical testing as a first-line treatment in advanced kidney cancer was led by Toni K. Choueiri, MD, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, has become a standard therapy.
Rutgers medical experts are available to discuss the FDA’s approval of Moderna’s coronavirus vaccine for emergency use and its rollout. The Rutgers New Jersey Medical School is one of only two sites for the Phase 3 trial of the Moderna…
The University of California’s two nationally ranked medical centers, UCSF and UCLA, and their nuclear medicine teams have obtained approval from the U.S. Food and Drug Administration to offer a new imaging technique for prostate cancer that locates cancer lesions in the pelvic area and other parts of the body to which the tumors have migrated.
Rutgers’ principal investigator for the Moderna phase 3 coronavirus vaccine clinical trial at Rutgers New Jersey Medical School is available to discuss the drugmaker’s submission of its vaccine to the U.S. Food and Drug Administration for regulatory approval. “It is…
Biogen tried, and failed, to win FDA committee approval for its anti-amyloid Alzheimer’s drug. The Alzheimer’s Association supported the application but did not reveal significant monies received from the firm.
A first-of-its-kind contraceptive developed at the University of Illinois Chicago has been approved by the U.S. Food and Drug Administration. The new contraceptive, called Phexxi, is a non-hormonal vaginal gel that can be used on-demand to prevent pregnancy.
Notice how hand sanitizer has made a comeback? It was running out, but this charitable initiative helped revive it by tapping into ethyl alcohol and FDA approval.