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
Lexicon Earns Third $10 Million Milestone Payment From Novo Nordisk for LX9851

Lexicon Pharmaceuticals, Inc.  announced that it has earned a third $10 million milestone payment in 2026 from Novo Nordisk A/S following the achiev...

August 26, 2026 | Wednesday | 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
Qosina Launches Regulatory Services to Support Medical Device Compliance

Qosina, a global supplier of single-use components for the medical device and life sciences industries, today announced the launch of Qosina Regulatory S...

August 25, 2026 | Tuesday | News
QT Imaging Advances Quantitative Breast Imaging With 3D, Radiation-Free Ultrasound

  As breast imaging continues to evolve toward more quantitative and patient-centred approaches, QT Imaging is developing a three-dimensional ultraso...

August 25, 2026 | Tuesday | Interview
Johnson & Johnson Wins EU Approval for TECVAYLI Plus Daratumumab in Earlier-Line Multiple Myeloma

Johnson & Johnson announced that the European Commission (EC) has approved an indication extension for TECVAYLI®(teclistamab) in combination with...

August 24, 2026 | Monday | 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
Orum Therapeutics Wins FDA Clearance for ORM-1153 AML Degrader-Antibody Conjugate

Orum Therapeutics(“Orum” or the “Company”), a biotechnology company pioneering the field of degrader-antibody conjugates (DACs), ...

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

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