Register Now: From Clinical to Commercial: Accelerating ADC Late-Stage Development with Technology Innovation and Integrated Platform
Logo Image
News|Podcasts|June 18, 2026 (Updated: June 10, 2026)

The BioPharm Brief: FDA Decisions, Vaccine Momentum, and Lymphoma Advances

Today's BioPharm Brief covers an FDA filing acceptance for Roche's Lunsumio and Polivy combination in lymphoma, a pediatric expansion for Merck's CAPVAXIVE vaccine, and a key advisory committee meeting for Moderna's mRNA-based flu vaccine.

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry.

Today's stories highlight three important FDA-related developments spanning oncology and vaccines.

First, Roche announced that the FDA has accepted its supplemental Biologics License Application for a combination of Lunsumio (mosunetuzumab) and Polivy (polatuzumab vedotin) for patients with relapsed or refractory large B-cell lymphoma. The filing is supported by data showing the combination significantly improved progression-free survival compared with standard treatment options, potentially offering a new chemotherapy-free approach for patients whose disease has returned after prior therapy.

Next, Merck received FDA approval for CAPVAXIVE, its 21-valent pneumococcal conjugate vaccine, in children and adolescents aged 2 through 17 years who are at increased risk for pneumococcal disease. The expanded indication extends protection to a vulnerable pediatric population and reflects growing efforts to broaden vaccine coverage against pneumococcal serotypes associated with invasive disease.

Finally, all eyes were on the FDA's Vaccines and Related Biological Products Advisory Committee as members evaluated Moderna's mRNA-based influenza vaccine, MFLUSIVA. The panel voted unanimously that the vaccine's benefits outweigh its risks for adults aged 50 and older, a recommendation that could pave the way for the first mRNA-based seasonal flu vaccine in the United States. The decision follows a closely watched regulatory review process and could have broader implications for future mRNA vaccine development beyond COVID-19.

Thanks for listening to The BioPharm Brief. For analysis and expert insights, please visit BioPharmInternational.com.

Key Insights

  • Roche moves closer to a potential new treatment option for relapsed or refractory large B-cell lymphoma.
  • Merck expands CAPVAXIVE's reach to high-risk pediatric patients.
  • Moderna's mRNA flu vaccine clears a major regulatory hurdle with unanimous advisory committee support.

Related to this article

View more
The BioPharm Brief: An AI-Designed Multibody ADC Enters the Clinic, Blackstone Backs Pfizer’s Monthly GLP-1, and enGene Readies a Bladder Cancer BLA
The BioPharm Brief: An AI-Designed Multibody ADC Enters the Clinic, Blackstone Backs Pfizer’s Monthly GLP-1, and enGene Readies a Bladder Cancer BLA
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
Read more
The BioPharm Brief: FDA Designations for a Bispecific CAR-T, a BLA for Friedreich’s Ataxia, and Phase 2b MASH Data for Efinopegdutide
The BioPharm Brief: FDA Designations for a Bispecific CAR-T, a BLA for Friedreich’s Ataxia, and Phase 2b MASH Data for Efinopegdutide
FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.
Read more
The BioPharm Brief: argenx Bets on Peptides, a Two-Bispecific Regimen in Prostate Cancer, and a New Take on T-Cell Engagers
The BioPharm Brief: argenx Bets on Peptides, a Two-Bispecific Regimen in Prostate Cancer, and a New Take on T-Cell Engagers
argenx agrees to acquire macrocyclic peptide developer Unnatural Products for up to about $1.15 billion, Johnson & Johnson’s pasritamig and JNJ-9401 bispecific regimen achieves a 73% PSA response in phase 1 in metastatic castration-resistant prostate cancer, and Janux Therapeutics’ TRBV6-targeted T-cell engager JANX011 shows deep B-cell depletion in healthy volunteers.
Read more
The BioPharm Brief: A Bispecific Approval in Head and Neck Cancer, TCR Bispecifics Head to the Clinic, and a New Antibody Target in Essential Thrombocythemia
The BioPharm Brief: A Bispecific Approval in Head and Neck Cancer, TCR Bispecifics Head to the Clinic, and a New Antibody Target in Essential Thrombocythemia
FDA grants accelerated approval to Johnson & Johnson’s subcutaneous EGFR/MET bispecific Rybrevant Faspro for previously treated head and neck squamous cell carcinoma, T-Therapeutics raises a $133 million Series B to take TCR-CD3 bispecifics into clinical trials, and Alethio Therapeutics raises a $90 million Series A to advance its first-in-class G6B antibody for essential thrombocythemia.
Read more
The BioPharm Brief: Ivonescimab Priority Review in China, Stargardt Gene Therapy Moves Toward Phase 3, and Longer Dosing Intervals for an IBD Bispecific
The BioPharm Brief: Ivonescimab Priority Review in China, Stargardt Gene Therapy Moves Toward Phase 3, and Longer Dosing Intervals for an IBD Bispecific
China’s NMPA grants priority review to Akeso’s PD-1/VEGF bispecific ivonescimab with chemotherapy for first-line biliary tract cancer, VeonGen Therapeutics aligns with FDA on a phase 3 design for its dual-AAV Stargardt gene therapy VG801, and Caldera Therapeutics’ IL-23p19×TL1A bispecific CLD-423 shows a half-life of more than 40 days in a phase 1a trial.
Read more
The BioPharm Brief: A $7 Billion Oncology Option Deal, a TL1A Pivot, and Oral Adalimumab Heads to the Clinic
The BioPharm Brief: A $7 Billion Oncology Option Deal, a TL1A Pivot, and Oral Adalimumab Heads to the Clinic
Boehringer Ingelheim licenses six preclinical ADC and T-cell engager programs from Sino Biopharmaceutical in a deal worth up to $7 billion, Spyre Therapeutics drops anti-TL1A antibody SPY072 in rheumatic diseases after phase 2 misses and turns to hidradenitis suppurativa, and Biora Therapeutics gets ethics approval for a first-in-human trial of its BioJet oral adalimumab capsule.
Read more