Trethera’s TRE-515 Receives FDA Fast Track Designation for Advanced Prostate Cancer Treatment

Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company developing first-in-class therapies for cancer and autoimmune d...

July 11, 2025 | Friday | News
Zhimeng Biopharma Receives CDE Approval to Advance CB03-154 into Phase 2/3 Trials for ALS in China

Shanghai Zhimeng Biopharma, Inc. ("Zhimeng Biopharma"), a clinical-stage biopharmaceutical company dedicated to innovative drug development for liver and...

July 10, 2025 | Thursday | News
SimBioSys Secures Third FDA Clearance for TumorSight™ Viz to Advance Precision in Breast Cancer Surgery

SimBioSys®, a clinical AI company leveraging spatial biophysics to drive precision in breast cancer treatment, today announced its third FDA 510(k) c...

July 10, 2025 | Thursday | News
Purespring Therapeutics Receives FDA Clearance to Initiate Clinical Trials for IgA Nephropathy Gene Therapy

Purespring Therapeutics, a precision nephrology company focused on transforming the treatment of kidney diseases, announces that the U.S. Food and Drug A...

July 10, 2025 | Thursday | News
Longeveron Receives FDA Clearance to Begin Phase 2 Trial of Stem Cell Therapy for Pediatric Dilated Cardiomyopathy

 Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and...

July 09, 2025 | Wednesday | News
Masitinib Receives FDA and EMA Authorisation for Confirmatory Phase 3 Trial in Metastatic Castrate-Resistant Prostate Cancer

MASITINIB RECEIVES FDA AND EMA AUTHORIZATION FOR CONFIRMATORY PHASE 3 TRIAL IN METASTATIC CASTRATE-RESISTANT PROSTATE CANCER, WITH BIOMARKER-DRIVEN PATIE...

July 07, 2025 | Monday | News
WeightWatchers Expands Collaboration With Novo Nordisk to Boost Access to FDA-Approved Wegovy® at Special Pricing

WeightWatchers Clinic Members Can Access FDA-Approved Wegovy® for $299 in July, a $200 Savings Offer to Improve Access as WeightWatchers’ Trust...

July 02, 2025 | Wednesday | News
Bristol Myers Squibb’s streamlined CAR T therapy labels signal broader patient access and regulatory confidence

Bristol Myers Squibb’s announcement that the US Food and Drug Administration has approved the removal of REMS programs an...

June 27, 2025 | Friday | News
Sanofi’s Riliprubart Secures FDA Orphan Drug Status for AMR in Transplants; Phase 2 Kidney Study Underway

Ongoing phase 2 study evaluating riliprubart for the potential prevention and treatment of active antibody-mediated rejection in kidney transplant reci...

June 25, 2025 | Wednesday | News
Novadip Biosciences Secures FDA RMAT Designation for NVD003 in Rare Pediatric Bone Disorder

Novadip Biosciences, a late-stage clinical biotechnology company specializing in regenerative medicine, announces that the FDA has granted the Regenerative...

June 24, 2025 | Tuesday | News
Bayer Submits US FDA Application for Gadoquatrane, a Low-Dose MRI Contrast Agent

FDA submission seeks approval for investigational gadolinium-based contrast agent (GBCA) gadoquatrane for contrast-enhanced magnetic resonance imagin...

June 18, 2025 | Wednesday | News
Medicovestor Receives FDA Orphan Drug Designation for Pancreatic Cancer ADC

Medicovestor, Inc., a biotechnology company advancing next-generation antibody-drug conjugates (ADCs), announced that the U.S. Food and Drug Administrati...

June 18, 2025 | Wednesday | News
BioAegis Therapeutics’ rhu-pGSN Receives FDA Fast Track Designation for ARDS, Advancing Development of Novel Immune Modulator

Fast Track status enables expedited regulatory review timelines and supports the development of recombinant human plasma gelsolin (rhu-pGSN), a novel imm...

June 18, 2025 | Wednesday | News
Sanofi’s Rilzabrutinib Receives FDA Orphan Drug Designation for Sickle Cell Disease

The US Food and Drug Administration (FDA) has granted orphan drug designation to rilzabrutinib, a novel, advanced, oral, reversible Bruton's tyrosine kin...

June 04, 2025 | Wednesday | News

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