AbbVie Wins FDA Nod for EMBLAVEO™, Tackling Antimicrobial-Resistant Infections

AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved EMBLAVEO™ (aztreonam and avibactam), as the first and only fixed-...

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
Partner Therapeutics Announces NEJM Publication of Phase 2 eNRGy Trial Results for Zenocutuzumab-Zbco (BIZENGRI®)

Partner Therapeutics, Inc. (PTx), a private, fully-integrated biotechnology company announced  that the New England Journal of Medicine (NEJ...

February 06, 2025 | Thursday | News
Zoetis Updates U.S. Label for Librela® (bedinvetmab) Following Post-Approval Experience

Zoetis Inc. announced that it has updated the U.S. label for Librela® (bedinvetmab injection), following its submission of a supplement to the U.S...

February 05, 2025 | Wednesday | News
Roche Announces FDA Approval of Susvimo® for Diabetic Macular Edema, Offering a Treatment with Fewer Injections

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced  that the US Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/...

February 05, 2025 | Wednesday | News
Roche's PATHWAY® Anti-HER2 Test Gains FDA Approval to Identify HER2-Ultralow Metastatic Breast Cancer Patients for ENHERTU® Treatment

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced  that the U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY® ant...

February 03, 2025 | Monday | News
Celltrion Announces FDA Approval of AVTOZMA® (CT-P47) as Biosimilar to ACTEMRA® for Multiple Indications

Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved AVTOZMA® (CT-P47, tocilizumab-anoh) in both an intravenous (IV) ...

January 31, 2025 | Friday | News
Mesoblast Advances U.S. Commercial Launch of Ryoncil® for Pediatric SR-aGvHD, with Key Milestones Ahead

Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases,  provided an update on the progres...

January 31, 2025 | Friday | News
Vertex Pharmaceuticals Announces FDA Approval of JOURNAVX™ (Suzetrigine) for Acute Pain Treatment

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that the U.S. Food and Drug Administration (FDA) has approved JOURNAVX™ (suzet...

January 31, 2025 | Friday | News
Roche Announces Positive Overall Survival Results for Itovebi™ in Advanced Breast Cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced positive topline results from the overall survival (OS) analysis of the phase III INAVO120 study investigating...

January 29, 2025 | Wednesday | News
Merck’s WELIREG® (belzutifan) Accepted for Priority Review by FDA for Advanced Pheochromocytoma and Paraganglioma

 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has accepted for prior...

January 28, 2025 | Tuesday | News
Norgine and X4 Pharmaceuticals Celebrate EMA Validation of Mavorixafor for WHIM Syndrome

Following the licensing agreement with X4 Pharmaceuticals, Norgine is pleased to see the announcement from X4 that their Marketing Authorization Applicatio...

January 27, 2025 | Monday | News
Biogen’s LEQEMBI® Gains FDA Approval for Once Every Four Weeks Maintenance Dosing in Alzheimer’s Disease

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

January 27, 2025 | Monday | News
Biogen's Higher Dose Regimen of Nusinersen for SMA Receives FDA and EMA Review

Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Applicati...

January 24, 2025 | Friday | News

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