Roche Wins FDA Approval to Expand HER2 Diagnostic Testing for Gastroesophageal Cancer

Roche  announced that it has received FDA approval for expanded use of its PATHWAY® HER2 (4B5) and VENTANA® HER2 Dual ISH DNA Probe Coc...

August 28, 2026 | Friday | News
Revolution Medicines Wins FDA Approval for RASONQUE in Metastatic Pancreatic Cancer

Revolution Medicines, Inc., a global commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patie...

August 28, 2026 | Friday | News
Immuneering Advances Atebimetinib Phase 3 Trial in First-Line Metastatic Pancreatic Cancer

Immuneering Corporation, a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, shared comments followi...

August 28, 2026 | Friday | News
Caliway Advances CBL-514 With U.S. FDA Clearance and Phase 3 Trial Launch

Caliway Biopharmaceuticals, a clinical-stage biopharmaceutical company developing innovative small-molecule therapeutics, announced two major clinical mi...

August 27, 2026 | Thursday | News
NeuroThera and Clearmind Advance MDMA-PEA Program With U.S. Patent Application Publication

SciSparc Ltd.(“Company” or “SciSparc”), announced that its  subsidiary, NeuroThera Labs Inc. (TSXV: NTLX) ("NeuroThera"), a ...

August 26, 2026 | Wednesday | News
FDA Grants Orphan Drug Designation to Lakefront’s Gamgertamig for Pemphigus

Lakefront Biotherapeutics NV  announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to gamgertamig for the ...

August 26, 2026 | Wednesday | News
Milestone Pharmaceuticals Enrolls First Patient in Phase 3 Trial of Etripamil for AFib-RVR

Milestone® Pharmaceuticals Inc. , a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medi...

August 24, 2026 | Monday | News
Teva’s Ecopipam NDA Accepted by FDA for Pediatric Tourette Syndrome

Ecopipam (EBS-101) is a first-in-class selective D1 (dopamine) receptor antagonist with Orphan Drug designation NDA acceptance is supported by po...

August 21, 2026 | Friday | News
Ultragenyx Wins FDA Accelerated Approval for GENGLYCOS in GSDIa

GENGLYCOS is the first gene therapy approval, and fifth FDA approval overall, for the company Approval provides a long-awaited first-ever option to redu...

August 21, 2026 | Friday | News
FDA Seeks Input on Regulatory Framework for GenAI-Enabled Medical Devices

The U.S. Food and Drug Administration issued a discussion paper on considerations for the regulation of generative artificial intelligence (GenAI)-enable...

August 20, 2026 | Thursday | News
Radiopharm Theranostics Schedules FDA Meeting for RAD101 Phase 3 Trial

RAD 101 Phase 2b trial demonstrated 93% concordance with MRI across all evaluable lesions, meeting the Phase 2 trial's primary endpoint End-of-Phase 2 m...

August 19, 2026 | Wednesday | News
Bristol Myers Squibb Receives FDA Accelerated Approval for ZENBEXUS in Multiple Myeloma

-Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved ZENBEXUS™ (iberdomide) in combination with darat...

August 18, 2026 | Tuesday | News
QIAGEN Wins FDA Clearance for QIAstat-Dx Bloodstream Infection Panel

QIAstat-Dx BCID GPF Plus AMR Panel detects 20 pathogen targets and 10 antimicrobial resistance markers from positive blood cultures in about one hour...

August 12, 2026 | Wednesday | News
Fresenius Kabi Recalls Tyenne Injection Lot Over Glass Particle Contamination

Fresenius Kabi, an operating company of the Fresenius Group, is recalling one lot of Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 m...

August 12, 2026 | Wednesday | News

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