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
Japan Becomes First Market Where Joenja Is Commercially Available for Children Aged 4 to 11

Launch marks first commercial availability of Joenja® (leniolisib) for children aged 4 to 11 worldwide OrphanPacific, Inc. serves as Marketing Au...

August 14, 2026 | Friday | News
Belite Bio Wins FDA Priority Review for Tinlarebant in Stargardt Disease

Prescription Drug User Fee Act target action date is February 12, 2027 If approved, tinlarebant would be the first-ever approved treatment for Stargar...

August 13, 2026 | Thursday | News

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