Revolution Medicines Reports the US FDA NDA Acceptance of Daraxonrasib for Previously Treated Metastatic PDAC

Shots: The US FDA has accepted the NDA for Revolution Medicines’ daraxonrasib to treat pts with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), plus daraxonrasib was selected for the FDA CNPV pilot program NDA was backed by P-III (RASolute 302) trial assessing daraxonrasib (300mg, QD, PO) vs CT, in above-mentioned pts, regardless of RAS mutation, which…

ByRidhi Rastogi2 hours ago

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Arrowhead Reports P-III (SHASTA-3 & SHASTA-4) Results on Plozasiran in Severe Hypertriglyceridemia (sHTG)

Shots: Arrowhead has reported topline P-III (SHASTA-3 & 4) trial results assessing plozasiran (25mg, SC, Q3M) vs PBO in sHTG pts (n=~750), where both trials met their 1EP of reduced median TGs by 79% & 81%, respectively, at 12mos. vs ~27% Pooled analyses showed significant reductions in AP event rates & total incidence rate, with…

ByRidhi Rastogi3 hours ago

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GSK Reports the US FDA Approval of Jideytro for Previously Treated ROS1-Positive NSCLC

Shots: The US FDA has approved Jideytro (zidesamtinib) for the treatment of adults with locally advanced or metastatic ROS1-positive NSCLC who received a prior ROS1 kinase inhibitor Approval was based on the global P-I/II (ARROS-1) trial evaluating Jideytro in pts (n=117) with advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 inhibitor Trial showed meaningful & durable…

ByRidhi Rastogi7 hours ago

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BridgeBio Pharma Reports the US FDA’s NDA Acceptance for Encaleret to Treat Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Shots: The US FDA has accepted NDA for encaleret to treat ADH1, with a PDUFA date of May 8, 2027, & no advisory committee planned. BridgeBio is prepared for a potential launch, while an EU MAA filing is expected in H2’26 Encaleret was evaluated in the P-III (CALIBRATE) trial, which met its 1 & 2EPs,…

ByRidhi Rastogi1 day ago

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Novartis Reports the US FDA’s Traditional Approval of Fabhalta to Treat Primary IgAN

Shots: The US FDA has granted traditional approval to Fabhalta (iptacopan) for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression Approval was based on the P-III (APPLAUSE-IgAN) trial, where Fabhalta slowed eGFR decline by 48% vs PBO over 2yrs., with an annualized mean change from baseline…

ByRidhi RastogiJuly 17, 2026

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Takeda Reports the P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis

Shots: Takeda has reported the 2 P-III (Latitude PsO 3001 & PsO 3002) trial results assessing zasocitinib (QD, PO) in 693 & 1108 adults, respectively, with mod. to sev. PsO, where both studies showed improved NAPSI scores vs PBO at 16wks. Trials also showed that 77% (3001) & 74% (3002) pts reached ssPGA 0/1 response…

ByRidhi RastogiJuly 17, 2026

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HoneyNaps Secures FDA Clearance for AI Sleep Diagnostic Software Somnum V3.0

Shots: The US FDA has granted 510(k) clearance to Somnum V3.0, an AI-based clinical decision support software to assist medical professionals in analyzing polysomnography data, incl. sleep staging & respiratory event detection Somnum V3.0 automatically detects apnea & hypopnea events, & classifies them as obstructive, central, or mixed sleep apnea. Validation data submitted to the…

ByRidhi RastogiJuly 16, 2026

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SpinaFX Medical Secures CE Mark MDR Approval for Triojection System

Shots: SpinaFX has received MDR CE Mark for its Triojection System, which delivers a controlled ozone-oxygen gas mixture for procedures. Triojection also received US FDA’ IDE approval in Jun 2026 SpinaFX is engaging distribution partners to launch Triojection in priority markets, initially targeting pts with persistent pain from contained herniated discs who have failed conservative…

ByRidhi RastogiJuly 16, 2026

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ElectroWire Medical Secures FDA 510(k) Clearance for LightningWire Transseptal System

Shots: The US FDA has granted 510(k) clearance to the LightningWire Transseptal Puncture System, indicated to create an atrial septal defect to enable the introduction of cardiovascular catheters LightningWire combines an electrosurgical guidewire & activation cable for transseptal access, working with preferred introducers & existing electrosurgical generators. Its insulation enables low-power puncture, while the 0.032-inch…

ByRidhi RastogiJuly 16, 2026

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Roche Receives the US FDA Priority Review for Gazyva to Treat Primary Membranous Nephropathy

Shots: The US FDA has granted Priority Review to the sBLA of Gazyva/Gazyvaro (obinutuzumab) in pMN, based on the P-III (MAJESTY) study assessing Gazyva vs tacrolimus in adults (n=142), with a decision expected by Nov 2026 Trial met its 1EP, with 36.9% adults achieving CR at 2yrs. vs 5.7%, plus showed superiority across key 2EPs…

ByRidhi RastogiJuly 15, 2026

Revolution Medicines Reports the US FDA NDA Acceptance of Daraxonrasib for Previously Treated Metastatic PDAC

Arrowhead Reports P-III (SHASTA-3 & SHASTA-4) Results on Plozasiran in Severe Hypertriglyceridemia (sHTG)

GSK Reports the US FDA Approval of Jideytro for Previously Treated ROS1-Positive NSCLC

BridgeBio Pharma Reports the US FDA’s NDA Acceptance for Encaleret to Treat Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Novartis Reports the US FDA’s Traditional Approval of Fabhalta to Treat Primary IgAN

Takeda Reports the P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis

HoneyNaps Secures FDA Clearance for AI Sleep Diagnostic Software Somnum V3.0

SpinaFX Medical Secures CE Mark MDR Approval for Triojection System

ElectroWire Medical Secures FDA 510(k) Clearance for LightningWire Transseptal System

Roche Receives the US FDA Priority Review for Gazyva to Treat Primary Membranous Nephropathy

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