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NEWS

Genentech Reports the US FDA’s sBLA Acceptance of Lunsumio VELO + Polivy for R/R Large B-Cell Lymphoma

Shots: The US FDA has accepted sBLA for Genentech's Lunsumio VELO (mosunetuzumab-axgb; SC) + Polivy (polatuzumab vedotin-piiq) for treating adults with r/r LBCL, incl. diffuse large B-cell lymphoma (DLBCL), after ≥1L of systemic therapy (PDUFA: Feb 9, 2027) sBLA was backed by the P-III (SUNMO) study assessing Lunsumio VELO + Polivy (IV) vs R-GemOx in the above…
June 18, 2026

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NEWS

GSK & Spero Therapeutics Report the US FDA Approval of Utebzi for Complicated Urinary Tract Infections (cUTIs)

Shots: The US FDA has approved Utebzi (tebipenem pivoxil; 600mg, PO, Q6H) for the treatment of cUTIs incl. pyelonephritis, in adults who have limited or no alternative oral treatment options, with launch expected by the end of 2026 Approval was supported by the P-III (PIVOT-PO) trial demonstrating that Utebzi was non-inferior to IV imipenem-cilastatin in…
June 18, 2026

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NEWS

Dimerix Inks a ~$340M Deal with Everest Medicine to Commercialize DMX-200 in Greater China, South Korea, and Southeast Asia

Shots: Dimerix has granted Everest exclusive rights to commercialize DMX-200 for all indications incl. FSGS, in Greater China, South Korea, Singapore, Malaysia, Thailand, Indonesia, Vietnam & Philippines; Dimerix will retain rights outside the licensed regions Dimerix will continue funding & conducting the P-III (ACTION3) study, while Everest will manage regulatory filings, maintenance of the regulatory…
June 16, 2026

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Astrazeneca
NEWS

AstraZeneca Reports FDA’s sBLA Acceptance Under Priority Review for Ultomiristo Treat IgA Nephropathy

Shots: The US FDA has accepted sBLA & granted priority review to AZ's Ultomiris (ravulizumab) for the treatment of adults with immunoglobulin A nephropathy (IgAN), with a PDUFA action date anticipated in Q4’26 sBLA was supported by the interim analysis data from the global P-III (I CAN/ALXN1210-IgAN-320) trial assessing Ultomiris (IV) vs PBO in ~510 adults with…
June 15, 2026

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Sanofi
NEWS

Sanofi’s Tzield Secures FDA Accelerated Approval to Preserve Endogenous Insulin Production in Recently Diagnosed Stage 3 T1D

Shots: The US FDA has granted accelerated approval to Sanofi's Tzield to delay the decline in endogenous (own) insulin production in pts (8-17yrs.) recently diagnosed with stage 3 T1D Approval was based on the P-III (PROTECT) trial assessing Tzield (n=217) vs PBO (n=111) in 328 children & adolescents (8-17yrs.) diagnosed with clinical stage 3 T1D…
June 15, 2026

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Astrazeneca
NEWS

AstraZeneca’s Truqap Combination Receives the US FDA Approval for PTEN-Deficient mAPMN/S Prostate Cancer

Shots: FDA has approved AZ's Truqap + abiraterone & ADT, along with its companion diagnostic test for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer; regulatory review is ongoing in the EU Approval was based on the global P-III (CAPItello-281) trial assessing Truqap + abiraterone & ADT vs PBO + abiraterone…
June 15, 2026

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Hutchmed
NEWS

HUTCHMED Reports the P-II/III (ESLIM-02) Trial Data on Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia at EHA 2026

Shots: HUTCHMED has reported the P-III data (n=90) from P-II/III (ESLIM-02) assessing sovleplenib in in adult patients with primary or secondary wAIHA who had relapsed or were refractory to prior ≥1L of standard treatment; NDA accepted under NMPA priority review in Apr 2026 Trial met its 1EP of improved durable response rates (66% vs 15%),…
June 12, 2026

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