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FDA grants accelerated approval to Rybrevant Faspro in head and neck cancer

FDA grants accelerated approval to Johnson & Johnson's Rybrevant Faspro in head and neck cancer, Rezera sets terms for a $200M IPO, and NICE pilots a six-month appraisal route for new medicines.
pharminent November 6, 2026

Pharminent · Daily Brief
November 6, 2026

Regulatory & Approvals

FDA grants accelerated approval to Rybrevant Faspro in head and neck cancer
The FDA granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease has progressed on or after platinum-based chemotherapy.
FDA →

European Commission expands Jyseleca approval to axial spondyloarthritis
Alfasigma received expanded European Commission approval for Jyseleca (filgotinib) to treat adult patients with active axial spondyloarthritis.
Pharmaceutical Technology →

NICE and NHS England pilot six-month appraisal for new medicines
NICE and NHS England are piloting a shorter initial assessment process for promising new medicines, aiming to cut appraisal times from 12 months to six.
Pharmaphorum →

MHRA sets out patient and public involvement plan for 2026-2030
The MHRA published a patient and public involvement and engagement (PPIE) plan for 2026-2030, under which it will consider a diverse range of patient and public opinions when making regulatory decisions.
Pharmaceutical Technology →

Clinical Data

Moderna and Oxford Ebola vaccines backed for pivotal DRC trial
Ebola vaccines from Moderna and the University of Oxford are set to be added to a trial in the Democratic Republic of the Congo, which is battling its largest-ever outbreak.
Pharmaphorum →$MRNA

J&J and AbbVie to present early trispecific antibody data at ASH
Johnson & Johnson and AbbVie are among the drugmakers set to showcase early data at ASH for trispecific antibodies in multiple myeloma.
BioPharma Dive →$JNJ$ABBV

Deals & Partnerships

Armada Acquisition to combine with Brains Bioceutical in $750M deal
Armada Acquisition entered a definitive business combination agreement with Brains Bioceutical, valuing Brains Bioceutical at an implied pre-money equity value of $750 million.
Pharmaceutical Technology →

Business & Finance

Rezera sets terms for IPO seeking more than $200M
Rezera, formerly known as NodThera, announced terms for its planned IPO, aiming to raise upwards of $200 million for its NLRP3 inhibitor pipeline.
Pharmaphorum →

Egetis sells priority review voucher for $190 million
Egetis has sold a priority review voucher for $190 million.
PharmExec →

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