Sanofi’s Venglustat Secures the US FDA Priority Review for Type 3 Gaucher Disease

Shots: The US FDA has accepted NDA & granted priority review to Sanofi's venglustat for the treatment of neurological manifestations of type 3 Gaucher disease (GD3), with the PDUFA action date of Nov 25, 2026 NDA was supported by the ongoing P-III (LEAP2MONO) trial assessing venglustat (QD, PO) vs enzyme replacement therapy (IV, Q2W) in 43 pts…

ByRidhi Rastogi2 days ago

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AbbVie Reports the US FDA Approval for Decnupaz to Treat Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Shots: The US FDA has approved AbbVie's Decnupaz (pivekimab sunirine-pvzy) for the treatment of adults with BPDCN Approval was supported by the global P-I/II (CADENZA) trial in 84 pts with CD123+ hematologic malignancies, incl. BPDCN, where pts received Decnupaz in both frontline (n=33) & relapsed/refractory (R/R) settings (n=51) without active CNS disease Trial reported a 69.7% composite…

ByRidhi Rastogi2 days ago

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Apogee Therapeutics Secures Up to $1.3B Financing from Blackstone to Advance Zumilokibart

Shot: Apogee will receive ~$1.3B in flexible, non-dilutive capital from Blackstone, incl. ~$800M of synthetic royalty & ~$500M in senior debt available at the mutual consent of both parties, to support the late-stage development & potential commercialization of zumilokibart Blackstone will provide ~$800M in synthetic royalty funding to Apogee in exchange for 15-year tiered royalties…

ByRidhi Rastogi3 days ago

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Junshi Biosciences Reports P-III (NEOTORCH) Trial Results on Toripalimab + CT for Resectable Stage II-III NSCLC

Shots: Junshi Biosciences has reported the final analysis from the P-III (NEOTORCH) trial assessing toripalimab + Pt-containing doublet CT vs PBO + CT as perioperative treatment in 501 pts with resectable stage II-III NSCLC pts Trial improved EFS, with mEFS not reached vs 15.1mos. for CT alone, reducing risk of recurrence, progression, or death by 60%,…

ByRidhi Rastogi3 days ago

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D&D Pharmatech Reports P-II Trial Results on Zabopegdutide for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Shots: D&D Pharmatech has reported the topline P-II (DD01-DN-02) trial data assessing zabopegdutide (DD01) vs PBO in 67 overweight/obese pts with MASH & significant liver fat across the US, which met its all 3 key histological EPs Pts received a 2wk. 20mg titration followed by maintenance dosing of DD01 (40mg, QW) or PBO; the Wk.…

ByRidhi Rastogi3 days ago

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Myriad Genetics Launches Prolaris + AI Test for Personalized Prostate Cancer Active Surveillance

Shots: Myriad Genetics to launch the Prolaris + AI Test, with the new AI metric available for all Prolaris Biopsy Tests in the US from May 29, 2026 excl. New York; approval in NY is expected soon A validation study of 998 pts for model training & 296 pts for validation, demonstrated that AI-GUR independently…

ByRidhi Rastogi3 days ago

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TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Alzheimer’s Disease Test

Shots: The US FDA has granted BDD to the TOBY Test for diagnosing Alzheimer’s disease in adults (≥50yrs.) with signs and symptoms of cognitive impairment undergoing evaluation for Alzheimer’s disease The TOBY Test is a non-invasive urine-based diagnostic designed to aid Alzheimer’s disease diagnosis by analyzing urinary volatile organic compound patterns using mass spectrometry and…

ByRidhi Rastogi3 days ago

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Sobi Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at EAS 2026

Shots: Sobi has reported pooled subgroup analysis (n=455) from P-III (CORE: n=617 & CORE2: n=446) trials assessing Tryngolza (olezarsen; 50 or 80mg, SC, Q4W) vs PBO in adults with severe hypertriglyceridemia (sHTG) & triglyceride (TG) levels ≥500 mg/dL Trial showed PBO-adjusted TG reductions of 66% (80mg) & 59% (50mg) at 6mos. in pts with TGs…

ByRidhi Rastogi3 days ago

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Eli Lilly Builds Infectious Disease Pipeline With 3 Acquisitions Valued ~$3.8B

Shots: Eli Lilly will acquire 3 companies, Curevo, LimmaTech Biologics, & Vaccine Company, to build its infectious disease portfolio through differentiated vaccine & platform technologies The deals incl. Curevo’s P-II shingles vaccine candidate amezosvatein, LimmaTech’s P-I vaccine LTB-SA7 targeting S. aureus infections, & Vaccine Company’s preclinical EBV vaccine platform leveraging proprietary in vivo nanoparticle technology As…

ByRidhi Rastogi4 days ago

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Merz Therapeutics and Kvvit Partner to Advance Inbrija in Mainland China, Hong Kong and Macao

Shots: Merz has granted Kvvit exclusive license to Inbrija (levodopa inhalation powder) in mainland China, Hong Kong, & Macao for intermittent treatment of OFF episodes in adults with Parkinson’s disease receiving levodopa/dopa-decarboxylase inhibitor Merz will supply Inbrija, oversee global quality & key regulatory activities, & act as Overseas Holder of the Drug Registration Certificate, while…

ByRidhi Rastogi4 days ago

Ridhi Rastogi

Sanofi’s Venglustat Secures the US FDA Priority Review for Type 3 Gaucher Disease

AbbVie Reports the US FDA Approval for Decnupaz to Treat Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Apogee Therapeutics Secures Up to $1.3B Financing from Blackstone to Advance Zumilokibart

Junshi Biosciences Reports P-III (NEOTORCH) Trial Results on Toripalimab + CT for Resectable Stage II-III NSCLC

D&D Pharmatech Reports P-II Trial Results on Zabopegdutide for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Myriad Genetics Launches Prolaris + AI Test for Personalized Prostate Cancer Active Surveillance

TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Alzheimer’s Disease Test

Sobi Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at EAS 2026

Eli Lilly Builds Infectious Disease Pipeline With 3 Acquisitions Valued ~$3.8B

Merz Therapeutics and Kvvit Partner to Advance Inbrija in Mainland China, Hong Kong and Macao

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