European Commission Grants Conditional Marketing Authorization for Gilead’s Seladelpar in Primary Biliary Cholangitis

Gilead Sciences, Inc. announced that the European Commission (EC) has granted conditional marketing authorization for seladelpar for the treatment of prima...

February 21, 2025 | Friday | News
GSK Announces China’s Acceptance of New Drug Application for Nucala (Mepolizumab) as COPD Treatment

GSK plc announced that the China National Medical Products Administration has accepted for review the new drug application for the use of Nucala ...

February 21, 2025 | Friday | News
Biogen and Stoke Therapeutics Collaborate on Zorevunersen for Dravet Syndrome Treatment

Biogen Inc.  and Stoke Therapeutics, Inc. announced a collaboration for the development and commercialization of zorevunersen, a potential f...

February 19, 2025 | Wednesday | News
Rznomics’ RZ-001 Receives Fast Track Designation from FDA for Hepatocellular Carcinoma Treatment

Rznomics announced on the 14th that its anticancer drug, RZ-001, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for t...

February 18, 2025 | Tuesday | News
TAHO Pharmaceuticals Announces Positive Preliminary Results for TAH3311, World’s First Oral Resolution Film of Apixaban

TAHO Pharmaceuticals announces positive preliminary results from the pivotal study of TAH3311, the world's first oral resolution film (ODF) of apixaban. Th...

February 18, 2025 | Tuesday | News
Zoetis Receives USDA Conditional License for Avian Influenza Vaccine for Chickens

Zoetis announced that the U.S. Department of Agriculture (USDA), Center for Veterinary Biologics (CVB) has issued the company a conditional license for its...

February 17, 2025 | Monday | News
Thailand FDA Approves NERLYNX® to Reduce Breast Cancer Recurrence and Improve Survival Outcomes

A NEW breast cancer therapy shown to significantly reduce the risk of cancer recurrence and improve disease-free survival in women is now approved for use ...

February 12, 2025 | Wednesday | News
CSL’s HEMGENIX® Delivers Long-Term Bleed Protection for Hemophilia B with Four-Year Data from HOPE-B Study

 Global biotechnology leader CSL announced the four-year results from the pivotal HOPE-B study confirming the long-term durability and safety of a one...

February 10, 2025 | Monday | News
Regeneron’s EYLEA HD® 8 mg Shows Promise for Retinal Vein Occlusion in Phase 3 QUASAR Trial

Regeneron Pharmaceuticals, Inc.announced the first presentation of positive results from the Phase 3 QUASAR trial investigating EYLEA HD® (afliber...

February 10, 2025 | Monday | News
Genentech's Gazyva® Demonstrates Significant Improvement in Lupus Nephritis in Phase III REGENCY Trial

Genentech, a member of the Roche Group, announced that a detailed analysis of its Phase III REGENCY trial of Gazyva® (obinutuzumab) in people with acti...

February 10, 2025 | Monday | News
AstraZeneca’s Imfinzi® Receives Positive CHMP Recommendation for Limited-Stage Small Cell Lung Cancer Treatment in the EU

AstraZeneca’s Imfinzi (durvalumab) has been recommended for approval in the European Union (EU) as monotherapy for the treatment of adults ...

February 05, 2025 | Wednesday | News
Vanda Pharmaceuticals and AnaptysBio Enter Exclusive Global License Agreement for Imsidolimab in GPP Treatment

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) and AnaptysBio, Inc. (Anaptys) (Nasdaq: ANAB) announced an exclusive, global license agreement ...

February 04, 2025 | Tuesday | News
Eisai and Biogen Provide Update on Lecanemab’s EU Regulatory Review for Early Alzheimer’s Disease

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusett...

February 04, 2025 | Tuesday | News
EMA's CHMP Recommends Opdivo® + Yervoy® for First-Line Treatment of Unresectable or Advanced Hepatocellular Carcinoma

 Bristol Myers Squibb (NYSE: BMY) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...

February 03, 2025 | Monday | News

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