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NEWS

BeOne Receives the US FDA Priority Review to  Tevimbra Combination for 1L Treatment of HER2+ GEA Cancers

Shots: FDA has granted priority review to BeOne's Tevimbra + Ziihera & CT for the 1L treatment of unresectable locally advanced/metastatic HER2+ gastric, GEJ, or esophageal adenocarcinoma; BeOne plans to participate in the FDA’s Project Orbis sBLA was based on the P-III (HERIZON-GEA-01) trial, which assessed Ziihera + CT ± Tevimbra vs Herceptin + CT as…
April 30, 2026

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NEWS

Laguna Biotherapeutics Reports the US FDA IND Clearance for LGNA-100 to Treat High-Risk Pediatric Leukemias

Shots: The US FDA has granted IND clearance to LGNA-100, Laguna Biotherapeutics’ lead clinical candidate from the QUAIL platform, to initiate the P-I trial The P-I single ascending dose study will assess safety, tolerability, & mechanism of LGNA-100 via IV infusion in pediatric & young adults with high-risk acute leukemias & MDS post αβ-depleted HSCT…
April 30, 2026

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Hutchmed
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HUTCHMED Reports NMPA’s NDA Acceptance under Priority Review for Sovleplenib to Treat wAIHA

Shots: The Chinese NMPA has accepted NDA & granted priority review to HUTCHMED's sovleplenib for the treatment of adults with warm antibody autoimmune hemolytic anemia (wAIHA) who had an inadequate response to ≥1 previous glucocorticoid treatment NDA was supported by the Chinese P-II/III (ESLIM-02) assessing sovleplenib vs PBO in adults with primary or secondary wAIHA who had…
April 29, 2026

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Astrazeneca
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AstraZeneca Reports US FDA Approval of Breztri Aerosphere for Asthma

Shots: The US FDA has approved AstraZeneca's Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) for the maintenance treatment of asthma in pts (≥12yrs.); regulatory review is ongoing in the EU, Japan & China Approval was based on the P-III (LOGOS & KALOS) trials evaluating Breztri Aerosphere vs PT009, Symbicort, and PT009 + Symbicort in ~4,300…
April 28, 2026

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Astrazeneca
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AstraZeneca Reports FDA Approval of Saphnelo for Systemic Lupus Erythematosus (SLE)

Shots: The US FDA has approved AstraZeneca’s Saphnelo pen (anifrolumab; 120mg, SC, QW, autoinjector) for the treatment of adults with SLE in combination with SoC Approval was based on the P-III (TULIP-SC) trial assessing Saphnelo pen vs PBO in 367 pts (18-70yrs.) with mod. to sev. SLE while receiving SoC, which showed Saphnelo reduced disease activity (1EP); full…
April 27, 2026

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NEWS

Tanabe Pharma Report the EC Approval of Onerji for Parkinson’s Disease (PD) 

Shots:  The EC has approved Onerji (levodopa/carbidopa) infusion for advanced PD pts with uncontrolled motor fluctuations. The therapy is being developed by its wholly owned subsidiary, NeuroDerm   Approval was based on the global P-III (BouNDless) trial, which demonstrated Onerji + supplemental oral LD/CD significantly increased ON time without troublesome dyskinesia and reduced OFF time vs immediate-release oral LD/CD. Favourable long-term safety and tolerability results were also observed in the…
April 27, 2026

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NEWS

X4 Pharmaceuticals’ Xolremdi Receives the EC’s Approval for WHIM Syndrome 

Shots:  The EC has approved Xolremdi (Mavorixafor), under exceptional circumstances, for the treatment of WHIM syndrome  Approval was supported by the global pivotal P-III (4WHIM) trial, PBO-controlled 52-wk study evaluating mavorixafor’s efficacy & safety in pts ≥12 yrs with WHIM syndrome  Xolremdi (PO, QD), a CXCR4 antagonist, is used in pts ≥12 yrs with WHIM syndrome to increase circulating mature neutrophils & lymphocytes  Ref: X4…
April 27, 2026

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