FDA issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion-positive cholangiocarcinoma, an ultra-rare, aggressive cancer that forms in the bile ducts.

Original title: “FDA Grants Seventh Approval under the National Priority Voucher Pilot Program”

The FDA’s extension will give reviewers more time to review a major amendment to Biogen and Eisai’s application for a subcutaneous induction formulation of Alzheimer’s therapy Leqembi. The new target action date is on Aug. 24.

Original title: “Biogen, Eisai hit with 3-month delay for starting SubQ Alzheimer’s therapy”

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines:…, Agenda Agenda of the PRAC meeting 4-7 May 2026Draft Reference Number…, PRAC statistics: May 2026 , , Glossary Safety signal assessments. A safety signal is information which suggests a new potentially caus

Original title: “Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 May 2026”

While the company claimed a victory, analysts said data from a Phase 1/2 study fell short of expectations. Entrada shares subsequently tumbled more than 50%.

Original title: “Entrada shares dive as Duchenne results disappoint”

The FDA turned away Ebvallo in January, taking issue with the design of the registrational trial. In a recent meeting, however, the agency agreed that the study could in fact support the cell therapy’s approval. The news comes a week after the departure of controversial biologics Director Vinay Prasad.

Original title: “FDA reverses course on Atara, Pierre Fabre’s twice-rejected cell therapy after Prasad’s exit”

This news announcement was updated on 7 May 2026 to include additional recommendations for strains for seasonal egg-derived and live-attenuated influenza vaccinesEMA has issued…

Original title: “EU recommendations for 2026/2027 seasonal flu vaccine composition”

Nihr‑funded phase 2 study to assess progesterone delivery using Callavid device

Original title: “Calla Lily Clinical Care begins dosing in trial of intravaginal platform for threatened miscarriage”

Johnson & Johnson plans to advance the co-antibody therapy, which combines its IL-23 blocker Tremfya and the TNF-alpha inhibitor Simponi, into late-stage testing for Crohn’s disease and ulcerative colitis.

Original title: “J&J pushes dual-antibody IBD therapy into Phase 3 despite mid-stage fails”

100% complete response (“CR”) rate among all 15 CAR-T-naïve efficacy evaluable patients treated with TPST-2003 dual-targeting CD19/BCMA CAR-T across two... 100% CR as measured by normalization of serum vascular endothelial growth factor levels (“CRVEGF“) rate among all five efficacy evaluable patients in POEMS-1 trial evaluating TPST-2003 in the rare disease, POEMS syndrome ... Results support clinical benefit of parallel-structure dual-targeting CAR architecture in patients with rrMM, including in patients with extramedullary disease (“EMD”) Median progression free survival of 23.1 months, including in patients with EMD, if replicated in registrational trial, would position TPST-2003 as potentially class-leading therapy for rrMM TPST-2003 is being developed in China by Tempest’s partner, Novatim Immune Therapeutics (“Novatim”). Under its agreement with Novatim, Tempest has the exclusive right to develop TPST-2003 outside of China, India, Turkey, and Russia. ... REDEEM-1 (Study nos. CTR20233309/NCT06223646) is a Phase 1/2a clinical trial evaluating TPST-2003 in patients with relapsed/refractory multiple myeloma, including patients with high-risk cytogenetics and patients with extramedullary disease. Xiaojing Yan), and The Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College (Dr. Dehui Zou). ... POEMS-1 is a Phase 1 clinical trial (Study nos. CTR20242409/NCT06518876) evaluating TPST-2003 in patients with POEMS, a rare blood disorder caused by abnormal plasma cells. NCT04714827) is evaluating TPST-2003 in patients with relapsed/refractory multiple myeloma, including patients with high-risk cytogenetics and patients with extramedullary disease. The IIT is sponsored and being conducted by Tempest’s partner, Novatim, with a total of two clinical sites registered in China: Shanghai Fourth People’s Hospital (Dr. Weijun Fu; lead site) and Shanxi Provincial Cancer Hospital (Dr. Liping Su). ... Tempest Therapeutics is a clinical-stage biotechnology company developing a pipeline of advanced CAR-T cell therapy product candidates to treat cancer.

Original title: “Tempest Presents Clinical Update at ISCT 2026 Annual Meeting”

FDA today authorized the marketing of four Glas electronic nicotine delivery systems (ENDS) through the premarket tobacco product application (PMTA) pathway.

Original title: “FDA Expands Market Access, Authorizes New ENDS Products”

Findings support once‑daily dosing and reinforce PALI‑2108’s potential

Original title: “Palisade Bio reports phase 1a/b data showing colon‑targeted exposure”

Study expands evaluation of survivin‑targeting vaccine

Original title: “MimiVax and Roswell Park open phase 2 trial of SurVaxM for metastatic neuroendocrine tumours”