NEWS

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…

2 days ago

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…

2 days ago

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)…

3 days ago

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…

3 days ago

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…

3 days ago

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…

3 days ago

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,…

3 days ago

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…

3 days ago

Innovent Biologics Licenses SP001 (IBI355) to Spero Therapeutics in a ~$1.1B Deal

Shots: Innovent will grant Spero Therapeutics exclusive rights to develop, research, manufacture, & commercialize SP001 worldwide, excl. Greater China, where Innovent will retain the rights In return, Innovent will receive an upfront payment & development, regulatory & commercial milestone payments, representing the total deal value of ~$1.1B, plus Innovent will also receive tiered royalties on…

4 days ago

BioMarin Reports the US FDA’s sNDA Acceptance for Full Approval of Voxzogo in Achondroplasia

Shots: The US FDA has accepted an sNDA for Voxzogo (vosoritide) for full approval in children with achondroplasia (PDUFA: Feb. 28, 2027) The sNDA was supported by long-term safety & efficacy data from the ongoing 111-205, 111-208, & 111-302 studies, demonstrating clinically meaningful improvements in growth & key skeletal measures, incl. body proportionality & arm span…

4 days ago

NEWS

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

BioMarin Reports the US FDA’s sNDA Acceptance for Full Approval of Voxzogo in Achondroplasia

Contact US

FOLLOW US