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TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Multi-Cancer Test

Shots:The US FDA has granted Breakthrough Device Designation to the urine-based Multi-Cancer Early Detection (MCED) test The non-invasive platform analyzes volatile organic compounds (VOCs) using spectroscopy & machine learning to detect multiple cancers from a single urine sampleThe test provides an alternative to blood-based screening, supporting scalable population screening, while the designation enables…
April 15, 2026

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QIAGEN Launches QIAstat-Dx BCID GPF Plus AMR Panel for Bloodstream Infection Syndromic Testing

Shots:QIAGEN has launched the CE-IVDR certified QIAstat-Dx BCID GPF Plus AMR Panel, marking its entry into syndromic testing for bloodstream infections The panel identifies 20 gram-positive bacterial & fungal pathogen targets & 10 antimicrobial resistance markers, delivering results in ~1 hour to support rapid clinical decision-making & antimicrobial stewardshipThe panel was showcased at…
April 15, 2026

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Partner Therapeutics Reports the US FDA sBLA Submission of Bizengri for NRG1 Fusion Positive Cholangiocarcinoma

Shots:The US FDA has received the sBLA of Bizengri (zenocutuzumab-zbco) for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusionsBLA was supported by eNRGy study assessing Bizengri in pts with NRG1 fusion-positive cancers, incl. cholangiocarcinoma, showing an ORR of 36.8% & mDOR of 12.9mos. per BICR, in…
April 15, 2026

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Henlius Receives NMPA IND Clearance for HLX05-N (Biosimilar, Erbitux)

Shots:The NMPA has granted IND clearance to Henlius’ HLX05-N, a biosimilar version of Erbitux (cetuximab), for the treatment of metastatic colorectal cancer (mCRC)HLX05-N showed high similarity to reference cetuximab in analytical & non-clinical studies, with Henlius planning to initiate an international multi-center P-I trial upon meeting required conditionsCetuximab is an anti-EGFR monoclonal…
April 15, 2026

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Eli Lilly to Acquire CrossBridge Bio for ~$300M

Shots:Eli Lilly has entered into a definitive agreement to acquire CrossBridge Bio, incl. its synergistic dual payload platform for the development of differentiated therapeuticsAs per the deal, Lilly will acquire CrossBridge Bio for ~$300M in cash, incl. an upfront payment & a subsequent milestone paymentCrossBridge Bio is advancing CBB-120, a TROP2-targeting TOP1i/ATRi…
April 15, 2026

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SynOx Therapeutics Reports Topline P-III (TANGENT) Trial Results on Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)

Shots:SynOx has reported the global P-III (TANGENT) trial data assessing emactuzumab (1000 mg Q2W × 5 doses over 8wks.) vs PBO in TGCT for 6mos., followed by 18mos. follow-up with option for open-label emactuzumab upon disease progressionTrial met 1 & 2EPs with high significance, improving ORR (RECIST v1.1) & Tumor Volume Score, along…
April 14, 2026

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Protaryx Medical Secures FDA Clearance for its Transseptal Access Device

Shots:The US FDA has granted 510(k) clearance to the Transseptal Puncture Device to advance minimally invasive access for left-heart procedures, with plans to begin US commercialization The Device is a next-gen system enabling zero-exchange access to the left heart, integrating RF guidewire tech with standard electrosurgical generators & an echogenic, extendable atraumatic probe to…
April 14, 2026

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Travere Therapeutics
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Travere Therapeutics Reports FDA Full Approval of Filspari for Proteinuria Reduction in FSGS

Shots:The US FDA has granted full approval to Filspari (sparsentan) to reduce proteinuria in pts (≥8yrs.) with focal segmental glomerulosclerosis (FSGS) without nephrotic syndromeApproval was based on the global P-III (DUPLEX) trial assessing Filspari vs irbesartan in 371 pts (8–75 yrs.) with biopsy-proven or genetic FSGS, following a 2wk. washout, with dose titration…
April 14, 2026

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