Merck’s Winrevair (sotatercept-csrk) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension (PAH)

Shots: The approval was based on the results from the P-III (STELLAR) trial evaluating Winrevair (0.7mg/kg) vs PBO + stable background therapy (SC, Q3W) in patients (n=163 vs 160) with PAH. The 1EP was change from baseline at wk.24 in 6MWD The results depicted a 41m median increase in 6MWD with Winrevair vs PBO along…

ByDipanshu DixitMarch 26, 2024

NEWS

Johnson & Johnson’s Opsynvi (macitentan and tadalafil) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension

Shots: The approval was based on the results from the P-III (A DUE) clinical trial evaluating the safety & efficacy of Opsynvi vs macitentan/tadalafil monotx. in patients with PAH (WHO FC II or III). The 1EP was a change from baseline in Pulmonary Vascular Resistance (PVR) at 16wks. The study depicted a greater reduction…

ByDipanshu DixitMarch 22, 2024

NEWS

Italfarmaco’s Duvyzat Obtains the US FDA’s Approval to Treat Duchenne Muscular Dystrophy

Shots: The US FDA has granted approval to Italfarmaco’s Duvyzat (givinostat), histone deacetylase (HDAC) inhibitor, to treat Duchenne muscular dystrophy (DMD) patients (6yrs. or above) The approval was supported by the P-III (EPIDYS) study assessing the safety & efficacy of Duvyzat (BID) vs PBO in DMD ambulant male patients (n=179, 6yrs. or above) The trial…

ByDipanshu DixitMarch 22, 2024

NEWS

Idorsia’s Tryvio Receives the US FDA’s Approval for the Treatment of Hypertension

Shots: The US FDA has approved Tryvio (12.5mg, oral, QD, with/without food) in addition with antihypertensive drugs to treat hypertensive adults not controlled on other drugs The P-III (PRECISION) trial assessed the efficacy of Tryvio for hypertensive adults with SBP ≥140 mmHg receiving at least 3 antihypertensive therapies with the 1EP as change in SiSBP…

ByDipanshu DixitMarch 20, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in February 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of February 2024 The US FDA approved a total of 7 drugs including 6 new molecular entities and 1 biologic leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was Takeda’s Eohilia (budesonide oral suspension) for treating eosinophilic…

BySenior EditorMarch 13, 2024

NEWS

Formosa Pharmaceuticals Receives the US FDA’s Approval for Clobetasol Propionate to Treat Post-Operative Inflammation and Pain Following Ocular Surgery

Shots: The US FDA has approved Formosa’s clobetasol propionate ophthalmic suspension 0.05% (APP13007) to treat post-operative inflammation & pain following ocular surgery Sosei Heptares will receive a payment of $2.5M from Formosa on achieving the milestone as per the agreement signed b/w them APP13007 was initially developed by Activus Pharma (subsidiary of Sosei) using its…

ByDipanshu DixitMarch 4, 2024

NEWS

The US FDA Approves Hugel’s Letybo for the Treatment of Glabellar Lines

Shots: The US FDA has granted approval to the company’s Letybo for 50 and 100 units to treat moderate-to-severe glabellar lines in adults The approval was based on the data from three P-III completed studies that recruited more than 1,000 participants across the US and the EU The data from the clinical studies showed the…

ByDipanshu DixitFebruary 28, 2024

NEWS

Eicos Sciences’ Aurlumyn (Iloprost) Receives the US FDA’s Approval for the Treatment of Severe Frostbite

Shots: The approval was based on the study evaluating the efficacy of Aurlumyn for treating patients (n=47) with severe frostbite, all received aspirin & SoC. Patients were divided into 3 treatment arms receiving Aurlumyn (IV, 6hrs., daily for up to 8 days) alone in arm 1 & unapproved medications with/without Aurlumyn in arms 2 &…

ByDipanshu DixitFebruary 14, 2024

NEWS

The US FDA Approves Takeda’s Eohilia (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis (EoE)

Shots: The approval was based on the results from 2 trials (Study 1) & (Study 2) evaluating the safety & efficacy of Eohilia (2mg, BID) vs PBO in patients (aged 11-56yrs. & 11-42yrs.) with EoE. The efficacy endpoints of the trials were histologic remission & change from baseline in patient reported DSQ post 12wks of…

ByDipanshu DixitFebruary 12, 2024

VIEWPOINTS

Anas Batikhi, Founder & CEO at Santechture Shares on RCM-Tech, A Necessity in The Healthcare Industry

Shots: Anas spoke about revenue cycle management in the healthcare sector and the traditional challenges in the healthcare RCM He also elaborated on how the evolving technologies can help to overcome the challenges in healthcare revenue cycle management The interview shows how Santechture is developing smart AI-based and cloud-based solutions to help healthcare providers develop…

BySenior EditorJune 2, 2023

Merck’s Winrevair (sotatercept-csrk) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension (PAH)

Johnson & Johnson’s Opsynvi (macitentan and tadalafil) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension

Italfarmaco’s Duvyzat Obtains the US FDA’s Approval to Treat Duchenne Muscular Dystrophy

Idorsia’s Tryvio Receives the US FDA’s Approval for the Treatment of Hypertension

Insights+: The US FDA New Drug Approvals in February 2024

Formosa Pharmaceuticals Receives the US FDA’s Approval for Clobetasol Propionate to Treat Post-Operative Inflammation and Pain Following Ocular Surgery

The US FDA Approves Hugel’s Letybo for the Treatment of Glabellar Lines

Eicos Sciences’ Aurlumyn (Iloprost) Receives the US FDA’s Approval for the Treatment of Severe Frostbite

The US FDA Approves Takeda’s Eohilia (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis (EoE)

Anas Batikhi, Founder & CEO at Santechture Shares on RCM-Tech, A Necessity in The Healthcare Industry

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