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+

A Complete Account of FDA Approvals in 2023

Shots: 2023 remained a year of notable approvals by the US FDA. Around 55 drugs were approved, by the US FDA in 2023 PharmaShots, in an enlightening report, brings a summarized analysis of the approved drugs. The most explored section remains Oncology, Neurology, and Hematology  For the complete report with analysis, reach out to us…

BySenior EditorFebruary 1, 2024

NEWS

Celltrion Reports BLA Submission for CT-P47 (Biosimilar, Actemra) to the US FDA for Treating Rheumatoid Arthritis

Shots : Celltrion has submitted BLA to the US FDA seeking approval for CT-P47 in both IV and SC route of administrations based on the P-III study The P-III study assesses the safety, efficacy, PK, and immunogenicity of CT-P47 vs Actemra for treating moderate to severe active rheumatoid arthritis with inadequate response to methotrexate…

ByDipanshu DixitJanuary 28, 2024

INSIGHTS+

New Drug Designations – December 2023

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 6 biological drugs, 10 small molecules, 5 cell and gene therapies, 1 recombinant fusion protein, 1 peptide and 2 devices Neurocrine Biosciences’ Crinecerfont, focused on the treatment of Congenital Adrenal Hyperplasia…

BySenior EditorJanuary 25, 2024

NEWS

Ligand Pharmaceuticals’ Zelsuvmi Receives the US FDA’s Approval for the Treatment of Molluscum Contagiosum

Shots: Zelsuvmi (berdazimer topical gel, 10.3%) received the US FDA’s approval as a novel drug for the treatment of molluscum infections in adults & pediatric patients aged ≥1yrs. Zelsuvmi is expected to be commercially available in the US by H2’24 The company evaluated the safety & effectiveness of the US FDA-approved Zelsuvmi in P-III clinical…

ByDipanshu DixitJanuary 8, 2024

VIEWPOINTS

Björn Mellgård shares insights from the Pivotal Phase III data of TAK-755 for congenital thrombotic thrombocytopenic purpura (cTTP)

Shots: Björn Mellgård Vice President and Global Program Lead, TTP Program, Takeda, shares insights from the P-III data of TAK-755 for the treatment of cTTP Björn eloquently shares the highlights of the study design for TAK-755, safety and efficacy outcomes, and goes on to share an update from the P-IIIb continuation trial evaluating TAK-755 With…

BySaurabh ChaubeyOctober 19, 2023

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

A Complete Account of FDA Approvals in 2023

Celltrion Reports BLA Submission for CT-P47 (Biosimilar, Actemra) to the US FDA for Treating Rheumatoid Arthritis

New Drug Designations – December 2023

Ligand Pharmaceuticals’ Zelsuvmi Receives the US FDA’s Approval for the Treatment of Molluscum Contagiosum

Björn Mellgård shares insights from the Pivotal Phase III data of TAK-755 for congenital thrombotic thrombocytopenic purpura (cTTP)

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