Regulatory
The interim final rule aligns payment for Medicare Part B therapeutics with international prices and removes incentives for physicians to prescribe more expensive drugs and biologics.
The end of November and beginning of December is marked by several PDUFA dates at the U.S. Food and Drug Administration (FDA). Here’s a look.
Genentech’s influenza treatment Xofluza® (baloxavir marboxil) has been granted approval by the U.S. Food and Drug Administration for use in people 12 years and older, making it the first single-dose post-exposure prophylaxis strategy approved by the agency.
The U.S. FDA approved Alnylam Pharmaceuticals’ Oxlumo (lumasiran) for primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in children and adults.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 24, 2020.
Eiger’s Zokinvy is the first-ever approved treatment for children with Huchinson-Gilford Progeria Syndrome and processing-deficient Progeroid Laminopathies.
Late Friday, the FDA gave the green light to Regeneron’s REGN-COV2, a combination of casirivimab and imdevimab.
The U.S. Food and Drug Administration (FDA) has a busy end of November planned, with numerous PDUFA dates to address. Here’s a look at the upcoming week.
The U.S. Food and Drug Administration has accepted ADC Therapeutics’ Biologics License Application (BLA) and granted priority review for the company’s relapsed/refractory diffuse large B-cell lymphoma (DLBCL) treatment, loncastuximab tesirine (Lonca).
The World Health Organization (WHO) recommends against using Gilead Sciences’ remdesivir as a treatment for COVID-19.
PRESS RELEASES