Agios Reports the US FDA Approval of Aqvesme for Anemia in Alpha or Beta Thalassemia

Shots: 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…

ByPrince GiriDecember 25, 2025

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SN BioScience Receives US FDA ODD for SNB-101 in Gastric Cancer

Shots: 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…

ByPrince GiriDecember 25, 2025

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The US FDA Approves Edwards Lifesciences’ SAPIEN M3 Mitral Valve Replacement System for Mitral Regurgitation

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…

ByPrince GiriDecember 25, 2025

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Zydus Partners with Bioeq for US Commercialization of Nufymco (Biosimilar, Lucentis)

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…

ByPrince GiriDecember 25, 2025

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Novo Nordisk Reports the US FDA Approval of Oral Wegovy for Weight Management

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…

ByRidhi RastogiDecember 24, 2025

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Roche Receives the US FDA Approval of Lunsumio VELO for Subcutaneous Use in R/R Follicular Lymphoma

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…

ByPrince GiriDecember 23, 2025

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Boehringer Ingelheim Receives the US FDA Approval of Jascayd (Nerandomilast) for Progressive Pulmonary Fibrosis

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…

ByRidhi RastogiDecember 22, 2025

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Cytokinetics Reports the US FDA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The US FDA has approved Cytokinetics’ Myqorzo (5, 10, 15 & 20mg) for the treatment of adults with symptomatic oHCM, available in second half of Jan 2026 through a restricted program via REMS Approval was based on P-III (SEQUOIA-HCM) trial of Myqorzo, showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen…

ByRidhi RastogiDecember 22, 2025

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Novo Nordisk Reports the US FDA’s NDA Submission of CagriSema for Weight Management

Shots: The U.S. FDA has accepted the NDA for Novo's CagriSema (cagrilintide 2.4mg + semaglutide 2.4mg) to support long-term weight loss & maintenance in adults with obesity or overweight & ≥1 related comorbidity, alongside lifestyle intervention NDA was supported by the P-III (REDEFINE 1) trial assessing CagriSema (QW) vs semaglutide 2.4mg alone, cagrilintide 2.4mg alone,…

ByRidhi RastogiDecember 19, 2025

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Pulse Biosciences Receives the US FDA IDE Approval to Initiate Study for nsPFA System in Paroxysmal Atrial Fibrillation (PAF)

Shots: The US FDA has granted IDE approval to initiate the NANOPULSE-AF study of Pulse's nsPFA Cardiac Catheter System for the treatment of PAF The study will assess the primary safety and efficacy of the nsPFA Cardiac Catheter System in ~145 pts for the treatment of drug-resistant symptomatic PAF across 30 sites, incl. 3 outside…

ByRidhi RastogiDecember 19, 2025

Agios Reports the US FDA Approval of Aqvesme for Anemia in Alpha or Beta Thalassemia

SN BioScience Receives US FDA ODD for SNB-101 in Gastric Cancer

The US FDA Approves Edwards Lifesciences’ SAPIEN M3 Mitral Valve Replacement System for Mitral Regurgitation

Zydus Partners with Bioeq for US Commercialization of Nufymco (Biosimilar, Lucentis)

Novo Nordisk Reports the US FDA Approval of Oral Wegovy for Weight Management

Roche Receives the US FDA Approval of Lunsumio VELO for Subcutaneous Use in R/R Follicular Lymphoma

Boehringer Ingelheim Receives the US FDA Approval of Jascayd (Nerandomilast) for Progressive Pulmonary Fibrosis

Cytokinetics Reports the US FDA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Novo Nordisk Reports the US FDA’s NDA Submission of CagriSema for Weight Management

Pulse Biosciences Receives the US FDA IDE Approval to Initiate Study for nsPFA System in Paroxysmal Atrial Fibrillation (PAF)

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