Sobi Reports the US FDA Approval of Gamifant for Macrophage Activation Syndrome in Still’s Disease

Shots: The US FDA has approved Gamifant (emapalumab-lzsg) for treating hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in Still's disease, including systemic Juvenile Idiopathic Arthritis (sJIA), in pts of all ages who are unresponsive, intolerant to glucocorticoids, or have recurrent MAS Approval was based on pooled data from two pivotal trials, P-III (EMERALD) and P-II (NI-0501-06),…

ByDipanshu DixitJune 30, 2025

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Daiichi Sankyo and AstraZeneca Report the US FDA Approval of Datroway for Advanced EGFR-Mutated NSCLC

Shots: The US FDA has approved Datroway (datopotamab deruxtecan-dlnk; 6 mg/kg) for adults with locally advanced or metastatic EGFR-mutated NSCLC previously treated with EGFR therapy & Pt CT Approval was based on the global P-II (TROPION-Lung05) trial results (n=137) and supported by data from the P-III (TROPION-Lung01) trial (n=590), which showed a 45% confirmed ORR…

ByDipanshu DixitJune 26, 2025

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GSK Receives the US FDA’s Approval for Benlysta to Treat Active Lupus Nephritis (LN)

Shots: The US FDA has approved Benlysta (belimumab) 200 mg/mL Autoinjector for SC use in pts (age≥5) with active LN receiving standard therapy Benlysta (belimumab) is a BLyS-specific inhibitor that reduces B cell survival and differentiation by binding to soluble BLyS, targeting autoreactive B cells. With this approval, GSK offers a first-of-its-kind at-home SC option…

ByDipanshu DixitJune 25, 2025

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Dizal Reports Enrollment Completion in P-III (WU-KONG28) Trial of Sunvozertinib for EGFRm NSCLC

Shots: Dizal has completed pts enrollment in P-III (WU-KONG28) trial of sunvozertinib as a 1L treatment of NSCLC harboring EGFR exon 20 insertion mutations (exon20ins); NDA under the US FDA’s priority review (PDUFA: Jul 7, 2025) Trial assessed sunvozertinib vs Pt-based doublet CTs in treatment-naïve NSCLC pts with EGFR exon20ins across 16 countries & regions…

ByRidhi RastogiJune 20, 2025

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Regeneron and Sanofi Receive the US FDA’s Approval for Dupixent to Treat Bullous Pemphigoid

Shots: The US FDA has approved Dupixent to treat adults with bullous pemphigoid based on P-II/III (ADEPT) trial assessing Dupixent vs PBO for 52wks.; regulatory review is ongoing in the EU, Japan, & China Pts (n=106) received a loading dose of Dupixent (300mg; n=53) or PBO (n=53), followed by Q2W dosing with OCS. OCS tapering began at Wks.…

ByRidhi RastogiJune 20, 2025

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Partner Therapeutics Reports CHMP’s Positive Opinion for Imreplys to Treat Exposure to Myelosuppressive Doses of Radiation

Shots: The CHMP has recommended Imreplys (sargramostim) to treat pts of all ages with Haematopoietic Sub-syndrome of Acute Radiation Syndrome (H-ARS) following myelosuppressive radiation exposure, across the EU, Norway, Iceland, and Liechtenstein Sargramostim is a recombinant human GM-CSF produced using yeast (S. cerevisiae) expression technology In 2018, the same formulation was approved by the US…

ByRidhi RastogiJune 20, 2025

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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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Incyte’s Monjuvi Regimen Receives the US FDA Approval for R/R Follicular Lymphoma

Shots: The US FDA has approved Monjuvi (tafasitamab-cxix) + rituximab & lenalidomide for the treatment of adult pts with r/r follicular lymphoma (FL) Approval was based on the P-III (inMIND) trial assessing Monjuvi regimen vs PBO + rituximab & lenalidomide in adults (n=654) with r/r Grade 1 to 3a FL or r/r nodal, splenic or…

ByRidhi RastogiJune 19, 2025

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Gilead Reports the US FDA’s Approval of Yeztugo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Shots: FDA has approved Yeztugo for PrEP in individuals (≥35kgs) at risk of HIV. MAA & EU-M4all filing are under EMA review, with ongoing reviews in Australia, Brazil, Canada, & South Africa; further filings are planned in Argentina, Mexico, & Peru Approval was based on P-III (PURPOSE 1 & 2) trials assessing Yeztugo (SC; twice…

ByRidhi RastogiJune 19, 2025

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Brain Navi Biotechnology Reports the US FDA’s 510(k) Clearance of NaoTrac for Neurosurgical Procedures

Shots: Brain Navi Biotechnology has received the US FDA’s 510(k) clearance for NaoTrac neurosurgical robot NaoTrac is a stereotaxic guiding surgical device that uses SMART tech for rapid, non-contact, frameless registration by aligning the pts anatomy with preoperative imaging, & a robotic arm to guide instruments while keeping the surgeon in control NaoTrac integrates AI…

ByRidhi RastogiJune 18, 2025

Sobi Reports the US FDA Approval of Gamifant for Macrophage Activation Syndrome in Still’s Disease

Daiichi Sankyo and AstraZeneca Report the US FDA Approval of Datroway for Advanced EGFR-Mutated NSCLC

GSK Receives the US FDA’s Approval for Benlysta to Treat Active Lupus Nephritis (LN)

Dizal Reports Enrollment Completion in P-III (WU-KONG28) Trial of Sunvozertinib for EGFRm NSCLC

Regeneron and Sanofi Receive the US FDA’s Approval for Dupixent to Treat Bullous Pemphigoid

Partner Therapeutics Reports CHMP’s Positive Opinion for Imreplys to Treat Exposure to Myelosuppressive Doses of Radiation

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

Incyte’s Monjuvi Regimen Receives the US FDA Approval for R/R Follicular Lymphoma

Gilead Reports the US FDA’s Approval of Yeztugo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Brain Navi Biotechnology Reports the US FDA’s 510(k) Clearance of NaoTrac for Neurosurgical Procedures

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