Neuspera Medical’s Integrated Sacral Neuromodulation System Secures the US FDA Approval for Urinary Urge Incontinence

Shots:The US FDA has approved integrated sacral neuromodulation (iSNM) system to treat urinary urge incontinence (UUI)iSNM device was evaluated in a P-II trial in 128 pts, which showed 84.2% pts achieved ≥50% reduction in urgent leaks, with 84% & 42% responders experiencing >75% & 100% reduction, respectively in UUI symptoms at 6mos.; 3.5x…

ByRidhi RastogiJune 19, 2025

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Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma

Shots: J&J has reported P-II (RedirecTT-1) trial data on Talvey (talquetamab-tgvs) + Tecvayli (teclistamab-cqyv) in 90 heavily pretreated r/r MM pts with extramedullary disease, where 84.4% were triple-class refractory, 35.6% penta-drug refractory, 20% had prior BCMA CAR-T, & 8.9% had prior bsAb exposureTrial showed a 78.9% ORR, with 54.4% achieving CR or better, incl.…

ByRidhi RastogiJune 16, 2025

NEWS

Celldex Highlights P-II Trial Data of Barzolvolimab for Chronic Spontaneous Urticaria at EAACI Congress 2025

Shots:The P-II trial assessed barzolvolimab (Q4W: 75 or 150mg; Q8W: 300mg) vs PBO for 16wks. in 208 CSU pts unresponsive to antihistamines, followed by 36wks. of active treatment, where 75mg & PBO pts were re-randomized to 150 or 300mg; pts were then followed for 24wks. Enrolment to P-III (EMBARQ-CSU1 & EMBARQ-CSU2) trials is ongoing …

ByRidhi RastogiJune 13, 2025

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Nuvation Bio Reports the US FDA’s Approval of Ibtrozi to Treat Advanced ROS1+ NSCLC

Shots: The US FDA has approved Ibtrozi (taletrectinib) for treating locally advanced or metastatic ROS1+ NSCLCApproval was based on the P-II [TRUST-I (China) & TRUST-II (global)] studies assessing Ibtrozi monotx. in 173 & 164 pts with ROS1+ NSCLC, respectivelyTRUST-I showed a cORR of 90% in TKI-naïve pts, with longest DoR of 46.9mos. &…

ByRidhi RastogiJune 12, 2025

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HUTCHMED and Innovent Biologics Report NMPA’s NDA Acceptance of Fruquintinib + Sintilimab for Renal Cell Carcinoma

Shots:China’s NMPA has accepted NDA of fruquintinib + sintilimab for the treatment of pts with locally advanced or metastatic renal cell carcinoma who have progressed on one tyrosine kinase inhibitor therapyNDA is backed by the P-II/III (FRUSICA-2) trial assessing fruquintinib + sintilimab vs axitinib/everolimus monotx. for 2L treatment of renal cell carcinoma pts…

ByRidhi RastogiJune 5, 2025

NEWS

Sanofi to Acquire Blueprint Medicines for ~$9.5B

Shots:Sanofi to acquire Blueprint Medicines, expanding its rare immunological disease portfolioAs per the deal, Blueprint shareholders will receive $129/share in cash (~$9.1B equity value) & one non-tradeable CVR of $2 & $4 per share upon achievement of development & regulatory milestones, respectively, for BLU-808, totaling the deal value up to $9.5B on a…

ByRidhi RastogiJune 2, 2025

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Kura Oncology and Kyowa Kirin Report the US FDA’s NDA Acceptance and Priority Review of Ziftomenib for Acute Myeloid Leukemia

Shots:The US FDA has accepted NDA & granted priority review seeking full approval of ziftomenib to treat adults with r/r acute myeloid leukemia (AML) with NPM1 mutation (PDUFA: Nov 30, 2025)NDA is supported by P-II (KOMET-001) trial assessing ziftomenib in r/r NPM1-mutant AML pts, which met its 1EP of CR & CR with…

ByRidhi RastogiJune 2, 2025

NEWS

Genentech Reports P-II (FENopta) Trial Data of Fenebrutinib for Relapsing Multiple Sclerosis (RMS)

Shots:Genentech has reported 96wk. data from P-II (FENopta) trial assessing fenebrutinib vs PBO for 12wks. in 109 RMS pts (18-55yrs.); 99 pts then opted for a 192wk. OLE study, with 93 remaining after 96wks.OLE study showed sustained efficacy over 96wks. with a low ARR of 0.06, no disability progression (per EDSS) & no…

ByRidhi RastogiMay 30, 2025

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Eli Lilly to Acquire SiteOne Therapeutics for ~$1B, Strengthening its Pain Pipeline

Shots:Eli Lilly has entered into a definitive agreement to acquire SiteOne Therapeutics incl. its asset, STC-004, expanding its pain pipeline As per the deal, SiteOne shareholders will receive an upfront payment as well as regulatory & commercial milestones for a total consideration of ~$1B in cash STC-004 is a non-opioid Nav1.8 inhibitor, which will advance into…

ByRidhi RastogiMay 28, 2025

NEWS

The US FDA Approves Arcutis Biotherapeutics’ Zoryve Topical Foam for Plaque Psoriasis

Shots:FDA has approved sNDA of Zoryve (0.3% roflumilast) for pts (≥12yrs.) with plaque PsO of scalp & body based on P-III (ARRECTOR) & P-II (Trial 204) trials assessing it vs vehicle in 736 pts for 8wks.ARRECTOR met its co-1EPs, with 66.4% vs 27.8% pts achieving Scalp-IGA success & 45.5% vs 20.1% pts attaining…

ByRidhi RastogiMay 23, 2025

Neuspera Medical’s Integrated Sacral Neuromodulation System Secures the US FDA Approval for Urinary Urge Incontinence

Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma

Celldex Highlights P-II Trial Data of Barzolvolimab for Chronic Spontaneous Urticaria at EAACI Congress 2025

Nuvation Bio Reports the US FDA’s Approval of Ibtrozi to Treat Advanced ROS1+ NSCLC

HUTCHMED and Innovent Biologics Report NMPA’s NDA Acceptance of Fruquintinib + Sintilimab for Renal Cell Carcinoma

Sanofi to Acquire Blueprint Medicines for ~$9.5B

Kura Oncology and Kyowa Kirin Report the US FDA’s NDA Acceptance and Priority Review of Ziftomenib for Acute Myeloid Leukemia

Genentech Reports P-II (FENopta) Trial Data of Fenebrutinib for Relapsing Multiple Sclerosis (RMS)

Eli Lilly to Acquire SiteOne Therapeutics for ~$1B, Strengthening its Pain Pipeline

The US FDA Approves Arcutis Biotherapeutics’ Zoryve Topical Foam for Plaque Psoriasis

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