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
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
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
Pfizer and Valneva Lyme Disease Vaccine Application Validated by EMA

Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA)  announced that the European Medicines Agency (EMA) has validated the Mar...

August 18, 2026 | Tuesday | News
Nanochon Receives Panama Approval to Begin First-in-Human Chondrograft Knee Study

Nanochon, a medical device company developing Chondrograft, a novel patented implant for the treatment of articular cartilage defects of the knee, announ...

August 17, 2026 | Monday | News
Aurisco Pharmaceutical Passes USFDA Inspection as First Generic Oligonucleotide API Manufacturer

Aurisco Pharmaceutical, a leading global Oligonucleotide and Peptide (TIDES) manufacturer, announced that its site in Yangzhou, China has passed the USFDA ...

August 17, 2026 | Monday | News
Veloxis Pharmaceuticals to Pay $46 Million to Resolve Envarsus XR Fraud Case

In a major healthcare fraud enforcement action, Veloxis Pharmaceuticals will pay over million and accept a stringent deferred prosecution agreement ...

August 17, 2026 | Monday | News
Summit Therapeutics’ Ivonescimab Regimen Gains Third NMPA Approval in China

Marks Third NMPA Approval in China for an Ivonescimab-Containing Regimen NMPA Approval Based on HARMONi-6 Clinical Trial Conducted by Akeso in China ...

August 14, 2026 | Friday | News

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