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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Novo Nordisk Reports the EC Approval of Wegovy Pill and Wegovy 7.2mg Injection for Weight Management

Shots: The EC approved Wegovy pill (25mg, QD, PO) as an adjunct to lifestyle intervention for weight management in adults with obesity or overweight, with ≥1 weight-related condition; launch expected in H2’26. The EC also approved Wegovy 7.2mg injection in a single-dose pen for obesity Wegovy pill approval was based on the OASIS clinical trial…

ByRidhi RastogiJuly 16, 2026

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Merck Reports P-III (KEYNOTE C93) Trial Data on Keytruda for Endometrial Cancer with dMMR Tumors

Shots: Merck has reported the P-III (KEYNOTE‑C93) trial assessing Keytruda (400mg, IV, Q6W for ~18 cycles) vs carboplatin + paclitaxel in pts (n=299) with dMMR advanced or recurrent endometrial cancer who have not previously been treated with systemic CT Trial met its 1EP of improved PFS, & showed improvements across ORR, CRR, & DoR; OS (1EP)…

ByRidhi RastogiJuly 15, 2026

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Chai Discovery Raises $400M Series C to Advance AI-Driven Drug Discovery

Shots: Chai Discovery has raised $400M in a Series C round to develop AI models that predict & engineer molecular interactions to speed preclinical drug discovery The Series C round, valuing Chai at $3.8B, was led by Index Ventures with participation from Kleiner Perkins, Sequoia Capital, Dimension, and several new and existing investors The company’s…

ByRidhi RastogiJuly 15, 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

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Kelun-Biotech Reports P-III Trial Findings on sac-TMT + Keytruda for 1L PD-L1-Negative Non-Squamous NSCLC

Shots: Kelun-Biotech has reported P-III (OptiTROP-Lung06) trial data assessing sacituzumab tirumotecan (sac-TMT/SKB264/MK-2870) + Keytruda vs CT + Keytruda as the 1L treatment for PD-L1-negative locally advanced or metastatic non-squamous NSCLC (TPS <1%) IDMC has concluded that the trial met its 1EP of improved PFS at interim analysis vs Keytruda + pemetrexed & Pt-based CT, plus…

ByRidhi RastogiJuly 15, 2026

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Insilico Medicine and Bora Pharmaceuticals Form AI-Driven Alliance with Potential Value Exceeding $2.5B

Shots: Insilico has entered into a multi-target strategic alliance with Bora to combine its Pharma.AI platform with Bora's expertise in drug development, manufacturing, quality, & commercialization Insilico will provide end-to-end AI solutions and R&D strategies to accelerate Bora’s AI- & automation-driven drug discovery & development, with plans to expand AI across development planning, process optimization,…

ByRidhi RastogiJuly 15, 2026

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The US FDA Approves Celcuity’s Revtorpyk (Gedatolisib) to Treat HR+/HER2- PIK3CA Wild-Type Breast Cancer

Shots: FDA has approved Revtorpyk for HR+, HER2-, PIK3CA wild-type locally advanced or metastatic breast cancer that has progressed after ≥1L of endocrine therapy (ET) in the metastatic setting; launch expected in late Q3’26 Approval was backed by PIK3CA wild-type cohort data from P-III (VIKTORIA-1), where Revtorpyk + fulvestrant + palbociclib improved mPFS (9.3 vs…

ByRidhi RastogiJuly 15, 2026

Ridhi Rastogi

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

Novo Nordisk Reports the EC Approval of Wegovy Pill and Wegovy 7.2mg Injection for Weight Management

Merck Reports P-III (KEYNOTE C93) Trial Data on Keytruda for Endometrial Cancer with dMMR Tumors

Chai Discovery Raises $400M Series C to Advance AI-Driven Drug Discovery

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

Kelun-Biotech Reports P-III Trial Findings on sac-TMT + Keytruda for 1L PD-L1-Negative Non-Squamous NSCLC

Insilico Medicine and Bora Pharmaceuticals Form AI-Driven Alliance with Potential Value Exceeding $2.5B

The US FDA Approves Celcuity’s Revtorpyk (Gedatolisib) to Treat HR+/HER2- PIK3CA Wild-Type Breast Cancer

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