The US FDA Grants Priority Review to Bayer’s Sevabertinib for HER2-mutant NSCLC

Shots:The US FDA has granted priority review to sevabertinib (BAY 2927088; reversible TKI) for the treatment of previously treated pts with advanced NSCLC harboring HER2 mutationsDesignation was based on the P-I/II (SOHO-01) trial assessing (20mg, BID, PO) in HER2-mutant NSCLC, with data previously reported from 2 cohorts: pts progressing on ≥1 systemic therapy who…

ByRidhi Rastogi1 day ago

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Regeneron’s Lynozyfic (Linvoseltamab) Receives the EC’s Conditional Approval for R/R Multiple Myeloma

Shots:The EC has granted conditional approval to Lynozyfic for the treatment of adults with r/r multiple myeloma based on P-I/II (LINKER-MM1) trial data assessing Lynozyfic in >300 pts; P-II dose expansion portion is ongoing. BLA under the US FDA’s Review (PDUFA: Jul 10, 2025)In the trial, 117 pts on 200mg had a 71% ORR, with…

ByRidhi RastogiApril 29, 2025

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Telix Pharmaceuticals Reports Preliminary P-II (IPAX-Linz) Trial Data of TLX101 to Treat Glioma

Shots:The IIT P-II (IPAX-Linz) trial assessed TLX101 (IV) in 8 glioblastoma pts with recurrent tumors & PET-confirmed amino acid uptake, who received adaptive dosing with ~4GBq before & ~2GBq after, 2L EBRT; 5/8 had MGMT-unmethylated tumorsTrial showed mOS of 12.4mos. or 32.2mos. from initial diagnosis, complementing P-I (IPAX-1) trial results of 13mos. & 23mos.,…

ByRidhi RastogiApril 17, 2025

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Accent Therapeutics to Highlight Preclinical Data of ATX-559 and ATX-295 at AACR 2025

Shots:Accent Therapeutics to present preclinical data of ATX-559 (DHX9 inhibitor) & ATX-295 (KIF18A inhibitor) at AACR 2025Presentation will highlight ATX-559’s activity in cancers exhibiting genomic instability & replication stress in in vivo models, incl. dMMR/MSI-H colorectal & BRCA-altered triple-negative breast cancer, plus ATX-295’s activity in ovarian cancer & its relation with whole genome…

ByRidhi RastogiMarch 26, 2025

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PharmaShots Interview: Recce Pharmaceuticals’ James Graham Shares Insight on the P-I/II Clinical Trial of RECCE 327 (R327) for Infected Burn Wounds

In an interview with PharmaShots, James Graham, CEO of Recce Pharmaceuticals shared his views on the multiple patient dosing in P-I/II clinical trial of RECCE 327 (R327) for the treatment of infected burn wounds.Shots:The multiple patients have been dosed in P-I/II trial evaluates the effectiveness & safety of RECCE 327 in 30 patients (10 will receive RECCE 327…

BySenior EditorSeptember 14, 2021

The US FDA Grants Priority Review to Bayer’s Sevabertinib for HER2-mutant NSCLC

Regeneron’s Lynozyfic (Linvoseltamab) Receives the EC’s Conditional Approval for R/R Multiple Myeloma

Telix Pharmaceuticals Reports Preliminary P-II (IPAX-Linz) Trial Data of TLX101 to Treat Glioma

Accent Therapeutics to Highlight Preclinical Data of ATX-559 and ATX-295 at AACR 2025

PharmaShots Interview: Recce Pharmaceuticals’ James Graham Shares Insight on the P-I/II Clinical Trial of RECCE 327 (R327) for Infected Burn Wounds

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The US FDA Grants Priority Review to Bayer’s Sevabertinib for HER2-mutant NSCLC

Regeneron’s Lynozyfic (Linvoseltamab) Receives the EC’s Conditional Approval for R/R Multiple Myeloma

Telix Pharmaceuticals Reports Preliminary P-II (IPAX-Linz) Trial Data of TLX101 to Treat Glioma

Accent Therapeutics to Highlight Preclinical Data of ATX-559 and ATX-295 at AACR 2025

PharmaShots Interview: Recce Pharmaceuticals’ James Graham Shares Insight on the P-I/II Clinical Trial of RECCE 327 (R327) for Infected Burn Wounds

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