Shots:
FDA has cleared Deseyne, a daily disposable soft contact lens for presbyopia that uses patented Extended Depth of Focus technology
Deseyne provides continuous near, intermediate, & distance vision through Cataltheia’s patented hyper-refractive central zone, showing a clinical advantage over multifocal lenses with minimal patient adaptation, strong comfort, & no adverse events reported in studies
Made…
Shots:
The US FDA has granted IND clearance to initiate a P-IIa trial of 9MW1911 for the treatment of patients with mod. to sev. chronic obstructive pulmonary disease (COPD)
In the China P-IIa trial (n=80) vs PBO, 9MW1911 showed dose-proportional exposure & dose-dependent efficacy, with the RP2D (n=30) reducing mod. to sev. COPD exacerbations by…
Shots:
The US FDA has approved Yartemlea for the treatment of HSCT-Associated Thrombotic Microangiopathy, with US launch planned for Jan 2026. MAA is under the EMA’s review, with a decision expected in mid-2026
Approval was based on the TA-TMA Study (n=28) plus EAP (N=221 adults & pediatric pts), where 19 pts (13 adult & 6…
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The US FDA has approved Agios’ Aqvesme (mitapivat) for the treatment of anemia in adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
Approval was based on the global P-III (ENERGIZE) and (ENERGIZE-T) studies (n=452), which met all 1EPs and 2EPs, demonstrating significant improvements in hemoglobin, fatigue, and reductions in transfusion burden vs PBO
Aqvesme…
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US FDA has granted Orphan Drug Designation (ODD) to SN BioScience’s SNB-101 for the treatment of gastric cancer, including gastroesophageal junction cancer
SNB-101 is currently under P-Ib/II development for small cell lung cancer and is being evaluated across multiple solid tumor indications in Korea, Europe and US
SNB-101 is a polymer nanoparticle formulation of…
Shots:
The US FDA has approved Edwards Lifesciences’ SAPIEN M3 transcatheter mitral valve replacement (TMVR) system as the transseptal transcatheter therapy for the treatment of symptomatic moderate-to-severe or severe mitral regurgitation (MR)
SAPIEN M3 is indicated for pts unsuitable for surgery or transcatheter edge-to-edge repair (TEER) therapy, including those with mitral valve dysfunction associated with…
Shots:
Zydus Lifesciences has entered into a strategic licensing, supply & commercialization agreement with Bioeq for Nufymco (ranibizumab), an interchangeable biosimilar to Lucentis, for the US market, marking an expansion of Zydus’ US biosimilar portfolio
Under the agreement, Bioeq will handle development, manufacturing, registration & supply of the finished product while Zydus will lead US…
Shots:
FDA has approved Wegovy (25mg, QD, PO) for weight loss, chronic weight management & major adverse CV events risk reduction in adults with obesity/overweight; US availability expected in early Jan 2026. Regulatory filing is made to the EMA & other authorities in H2’25
Approval was based on the P-IIIb (OASIS 4) trial assessing oral…
Shots:
The US FDA has approved Roche’s Lunsumio VELO (mosunetuzumab) as an SC formulation for the treatment of adults with r/r follicular lymphoma (FL) after ≥2L of systemic therapy, under accelerated approval
Approval was based on the P-I/II (GO29781) study in third-line or later FL pts, where Lunsumio VELO demonstrated an ORR of 75% and…
Shots:
The US FDA has approved Jascayd for the treatment of adults with progressive pulmonary fibrosis (PPF)
Approval was based on the P-III (FIBRONEER-ILD) trial of Jascayd vs PBO, where Jascayd significantly reduced lung function decline at Wk. 52, with FVC decreases of 86mL (18mg) & 69mL (9mg) vs 152mL with PBO, showing clinically meaningful…

