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

Celltrion Submits BLA to the US FDA for CT-P39 (Biosimilar, Xolair)

Shots: Celltrion has reported BLA submission for CT-P39, biosimilar version of Xolair (omalizumab), to the US FDA for all indications as of the reference product incl. asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy (US only) & CSU The submission was supported by the data, showing comparable efficacy & safety, from P-III study…

ByDipanshu DixitMarch 10, 2024

NEWS

Sandoz Reports the US FDA’s Approval of Wyost and Jubbonti (Biosimilar, Denosumab)

Shots: Sandoz has received the US FDA’s approval for Wyost & Jubbonti (denosumab-bbdz), biosimilars of Xgeva & Prolia (denosumab), based on the clinical studies demonstrating their similarity with the reference drugs The company’s Jubbonti Risk Evaluation & Mitigation Strategy (REMS) program has also been approved to educate HCPs & patients about the severe hypocalcemia risk…

ByDipanshu DixitMarch 5, 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

The US FDA Approves Allecra Therapeutics’ Exblifep for the Treatment of Complicated Urinary Tract Infections (cUTIs)

Shots: The US FDA has granted approval to the company’s Exblifep for the treatment of complicated urinary tract infections (incl. pyelonephritis) patients (18yrs. & above) along with a 5-yr. marketing exclusivity extension until 2032 The approval was based on clinical data that showed the effectiveness of Exblifep against antimicrobial resistance in gram –ve bacteria, especially…

ByDipanshu DixitFebruary 27, 2024

INSIGHTS+

New Drug Designations – January 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EC, and China’s NMPA. This month’s report includes 13 small molecules, 7 devices, 3 biologics ADC, 3 gene therapy, 1 antineoplastics, 1 protein, 1 peptide, 1 recombinant enzyme & 1 vaccine NRx Pharmaceuticals’ NRX-101 small molecule, focused…

BySenior EditorFebruary 20, 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

INSIGHTS+

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

Shots: The US FDA approved 1 NDA in January 2024, leading to treatments for patients and advances in the healthcare industry In January 2023, Zelsuvmi was approved by the US FDA for the Treatment of Molluscum Contagiosum PharmaShots has compiled a list of US FDA-approved drugs in the month January 2024 1. Ligand Pharmaceuticals’ Zelsuvmi Receives…

BySenior EditorFebruary 8, 2024

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

Celltrion Submits BLA to the US FDA for CT-P39 (Biosimilar, Xolair)

Sandoz Reports the US FDA’s Approval of Wyost and Jubbonti (Biosimilar, Denosumab)

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

The US FDA Approves Allecra Therapeutics’ Exblifep for the Treatment of Complicated Urinary Tract Infections (cUTIs)

New Drug Designations – January 2024

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)

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

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