BeiGene: CHMP Issues Positive Opinion Recommending Approval Of BRUKINSA - Quick Facts

By RTTNews Staff Writer ✉ | Published: 10/14/2022 6:41 AM ET

BeiGene (BGNE) announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending approval of
BRUKINSA for the treatment of adult patients with chronic lymphocytic leukemia. The European Commission will consider the Marketing Application, with a final decision expected within 67 days of receipt of the CHMP opinion.

BeiGene noted that, last month, CHMP issued a positive opinion recommending approval of BRUKINSA for the treatment of adult patients with MZL who have received at least one prior anti-CD20-based therapy.

For More Such Health News, visit rttnews.com.

For comments and feedback contact: editorial@rttnews.com

Business News

Biotech Stocks Facing FDA Decision In February 2023

Biotech stocks Facing FDA Decision in January 2023

Biotech Stocks Facing FDA Decision In December 2022

Editors Pick

Pfizer Q4 Profit Tops View; Sees Weak FY23 Results, Below Market

Drug major Pfizer Inc. reported Tuesday higher earnings in its fourth quarter, above market estimates, and an all-time high revenues in its fiscal 2022. Meanwhile, the company projects sharply lower adjusted earnings and revenues in its fiscal 2023, below Wall Street estimates, reflecting projected decline for COVID-19 products. In pre-market activity on the NYSE, Pfizer shares were losing around

Exxon Mobil Q4 Results Top Estimates

Oil major Exxon Mobil Corp. (XOM) reported Tuesday that fourth-quarter net income was $12.75 billion or $3.09 per share, up from $8.87 million or $2.08 per share in the prior-year quarter. Excluding special items, adjusted earnings were $3.40 per share, compared to $2.05 per share in the prior-year...

Daiso Recalls Matsunaga Mini Shiruko Sand Biscuits

La Mirada, California-based Daiso California LLC is recalling certain Matsunaga Mini Shiruko Sand Biscuits citing undeclared soy, an allergen, the U.S. Food and Drug Administration said. The recall incolves Matsunaga Mini Shiruko Sand Biscuits with sku 4902773016966, packaged in four pink and cream bags chained together. Each individual serving is 25g for an entire product weight of 100g.

Latest Updates on COVID-19

Covid-19 Remains An International Emergency: WHO

U.S. Covid Metrics Signal Ease In Pandemic

FDA Advisors Propose To Replace Primary COVID Shots With New Bivalent Shots

US Covid Deaths Rise By 78% In 2 Weeks

78% Increase In US Covid Deaths In A Fortnight

COVID-19: Drugs in Development

Follow RTT

Most Read
Most Emailed

BeiGene: CHMP Issues Positive Opinion Recommending Approval Of BRUKINSA - Quick Facts

Biotech Stocks Facing FDA Decision In February 2023

FDA Advisors Propose To Replace Primary COVID Shots With New Bivalent Shots

Syros Gets Fast Track Designation In U.S. For Tamibarotene For Myelodysplastic Syndrome Treatment

Sartorius Stedim Biotech FY22 Profit Rises, Orders Down; Sees Growth In FY23; Raises FY25 Sales View

Caterpillar Inc. Q4 Profit Decreases, misses estimates

Evotec Partners With Janssen Biotech To Develop Immune-based Cancer Therapies

Resmed Inc Q2 Profit Increases, beats estimates

Sartorius FY22 Prelim Earnings, Revenue Rise

Merck's KEYTRUDA Gets FDA Approval To Treat Stage IB, II, IIIA Non-small Cell Lung Cancer Patients

Regeneron Pharma: CHMP Adopts Positive Opinion For Dupixent

Eisai : EMA Accepts MAA For Lecanemab As Treatment For Early Alzheimer's Disease

Ipsen: CHMP Recommends Not To Grant Marketing Authorization For Palovarotene As Treatment For FOP

Toyota Is World's Top-selling Automaker Again

TFS FINANCIAL CORP. Q1 income increases in line with estimates

Playtech Plc Projects FY22 Adj. EBITDA To Rise 26%

Eastern Bankshares Down 11% As Q4 Earnings Fell Shy Of Estimates

Philip Morris Int'l To Commercialize KT&G's Smoke-Free Products Outside South Korea

Corning Q4 Profit Tops Estimates; Issues Q1 Guidance

Ipsen: CHMP Recommends Not To Grant Marketing Authorization For Palovarotene As Treatment For FOP

Archer-Daniels-Midland Q4 Profit Increases, beats estimates

CNX Resources Corporation Q4 Income Climbs

Eisai : EMA Accepts MAA For Lecanemab As Treatment For Early Alzheimer's Disease

Syros Gets Fast Track Designation In U.S. For Tamibarotene For Myelodysplastic Syndrome Treatment

M.D.C. Holdings Q4 Net Income Declines; Home Sale Revenues Up 4%