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Natera Seeks US FDA Approval for Signatera Cdx To Support MRD-Guided Treatment in Bladder Cancer

Shots: The US FDA has received a premarket approval (PMA) application of Signatera CDx for the detection of molecular residual disease (MRD) in pts with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with Tecentriq (atezolizumab) Submission was supported by the P-III (IMvigor011) trial, which met its 1EP & showed that Signatera-guided therapy improved…
February 2, 2026

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Origami Therapeutics Collaborates with Ipsen to Develop Protein Degrader Program for Neurodegenerative Disorder

Shots: Origami Therapeutics has entered into a global collaboration & option agreement with Ipsen to develop a small-molecule protein degrader, using Origami’s Oricision platform, for a rare inherited neurodegenerative disorder Under the deal, Ipsen will secure an exclusive option to license the program globally after drug candidate nomination &, upon exercise, would take over worldwide…
February 2, 2026

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Alvotech and Sandoz Partner to Expand Access to Biosimilars Across Canada, Australia, & New Zealand

Shots: Alvotech has entered into supply & commercialization agreements with Sandoz for multiple biosimilar candidates across Canada, Australia, & New Zealand In Canada, the deal includes one ophthalmology biosimilar in a prefilled intravitreal syringe, while in Australia & New Zealand, it covers 3 biosimilar candidates across immunology & gastroenterology in multiple formulations As per the…
February 2, 2026

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Johnson & Johnson Gains CHMP Positive Opinion for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The CHMP has recommended label expansion of Akeega (niraparib & abiraterone acetate tablet) + prednisone/prednisolone + androgen deprivation therapy (ADT) to treat adults with mHSPC & BRCA1/2 mutations Opinion was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/ prednisolone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic…
February 2, 2026

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Sanofi
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Sanofi Receives the CHMP Positive Opinion for Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD)

Shots: The CHMP has recommended Rezurock (200mg) for conditional approval in chronic GVHD pts (≥12yrs., ≥40kg), with EC’s decision expected in the coming wks. Opinion was supported by extensive clinical data, incl. the P-II (ROCKstar) trial, which showed an improved ORR of 74% in chronic GVHD pts post–stem cell transplant & after ≥2 prior systemic…
February 2, 2026

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UCB Reports the CHMP Positive Opinion of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

Shots: The CHMP has recommended Kygevvi (PO) under exceptional circumstances for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age, supported through EMA's PRIME scheme. EC decision is expected by Q2’26 Supportive evidence came from pooled data from 2 studies of Kygevvi in 39 pts with genetically confirmed TK2d & symptom…
February 2, 2026

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CSPC Pharmaceutical and AstraZeneca Seal ~$18.5B Long-Acting Peptide Deal for Obesity

Shots: CSPC has entered a strategic collaboration & license deal with AZ to develop long-acting peptides, using CSPC’s sustained-release delivery tech platform & AI-driven peptide drug discovery platform As per the deal, the Group will collaborate with AZ on novel peptide discovery & long-acting delivery, while AZ will gain exclusive global rights (excl. Greater China)…
January 30, 2026

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Recordati and Moderna Collaborate To Develop And Commercialize mRNA 3927 in a ~$160M Deal

Shots: Recordati has entered into a collaboration & license deal with Moderna to develop & commercialize mRNA-3927 globally for the treatment of propionic acidemia As per the deal, Moderna will continue to co-develop mRNA-3927 with Recordati, while Recordati will lead global commercialization if approved. In exchange, Moderna will receive $50M upfront, ~$110M in development &…
January 30, 2026

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KORU Medical Systems Receives the US FDA Clearance for FreedomEDGE System to Deliver Rystiggo in gMG Patients

Shots: The US FDA has granted 510(k) clearance to FreedomEDGE infusion system to subcutaneously administer Rystiggo (rozanolixizumab-noli) in generalized myasthenia gravis (gMG) patients FreedomEDGE Infusion System enables efficient large-volume SC drug delivery, expanding from home use to clinic-based care to deliver life-changing therapies across various care settings The system supports SC drugs with varying viscosity, flow…
January 30, 2026

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