logo

FDA Calendar

Company Name Roche Holding AG
RHHBY
Drug Name POLIVY (sBLA)
Event Name FDA panel to review POLIVY for expanded use in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma
Event Date 03/09/2023
Outcome Date 03/09/2023
Outcome FDA panel voted 11 to 2 in favour of Polivy in combination with R-CHP for people with previously untreated diffuse large B-cell lymphoma on Mar.9, 2023
Drug Status
Rival Drugs
Market Potential POLIVY recorded net sales of CHF 437 million in full-year 2022, up 85% over 2021
Other Approvals POLIVY was approved by the FDA in June 2019 for use in combination with bendamustine and rituximab for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, who have received at least two prior therapies.
News
Return to FDA Calendar

Editors Pick
Bloomington, Minnesota -based Hoyo, SBC is recalling around 1,046 pounds of ready-to-eat beef sambusa products citing possible foreign matter contamination, the U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS announced. The recalled products may be contaminated with extraneous materials, specifically thin, wire-like metal. New York-based Mockingbird LLC has expanded its initial recall in November to now include about 25,390 units of single strollers citing risk for fall, the U.S. Consumer Product Safety Commission said. The company in November last year had recalled about 149,000 units of single-to-double strollers due to the same concern. First Republic Bank, the latest casualty in the ongoing banking turmoil, said it has secured around $30 billion funding from America's 11 largest banks as a lifeline, including JPMorgan Chase, Bank of America, Citigroup, and Wells Fargo. Following the news, the bank's stock, which has been sinking since last week, gained around 10% on Thursday from the previous day's close.
The Department of Health and Human Services has unveiled the first set of Part B prescription drugs that will be subject to Medicare inflation rebates because they raised their prices faster than inflation. Under prescription drug law, prescription drug companies have to pay back Medicare if they raise prices on seniors at a higher rate than inflation. From next month, some Medicare beneficiar
The U.S. Food and Drug Administration has authorized bivalent Pfizer-BioNTech covid-19 vaccine as booster dose for certain children 6 months through 4 years of age. In a statement, the health regulator said it has amended the emergency use authorization or EUA of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. According to the agency, children 6 months through 4 years of age who completed ...
Key findings from the 2022 World Air Quality Report reveal the dangerous levels of air pollution measured in most of the 131 countries and regions under study. 118 countries exceeded the WHO annual PM2.5 guideline value of 5 µg/m3, says IQAir's 5th Annual World Air Quality Report. The top five most polluted countries in 2022 were Chad (89.7 µg/m3 - more than 17 times higher than the WHO annual g
Read More