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Nitisinone Becomes First and Only FDA-Approved Treatment for HGA in Adults With AKU

Pharmacy Times

With this action, nitisinone is the first and only FDA-approved treatment for AKU. 1 AKU, also known as black urine disease, is a rare inherited disorder that prevents the patient’s body from completely breaking down 2 amino acids, tyrosine and phenylalanine.

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Looking Beyond mRNA-based COVID-19 Vaccines to Innovative Therapeutics

PharmaTech

cancer and vaccines), and non-immunogenic applications (e.g., cancer and vaccines), and non-immunogenic applications (e.g., Several types of mRNA-based vaccines have emerged, namely non-replicating linear mRNAs (NRM), self-amplifying mRNAs (saRNAs), and circular mRNAs (circRNAs). Types of messenger RNA (mRNA)-based vaccines.

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Wockhardt has high hopes for novel antibiotic Zaynich

pharmaphorum

R&D Life Sciences Industry Report - Biologics and Generics The importance of biosimilars only continues to grow, driven by the potential savings they are able to deliver to healthcare systems. Website and content copyright © 2009- 2025 , pharmaphorum media limited or its licensors; all rights reserved.

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Barriers are limiting UK childhood vaccination, say doctors

pharmaphorum

The Vaccination in the UK: Access, uptake and equity (PDF) report notes that, over the last decade, the uptake of vaccines in the UK has stalled and is in many cases falling, leading to outbreaks of preventable diseases such as measles and whooping cough.

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Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program

FDA Law Blog: Biosimilars

In the eleven years from 2009 to the end of 2019, FDA awarded 11 tropical disease PRVs for the development of therapies for diseases such as malaria, tuberculosis, dengue, and river blindness. See Table 1. While lapse of this program may raise concerns about the end of the Tropical Disease PRV, such a result is highly unlikely.

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GRIN Therapeutics: Seeking to address unmet needs in rare neurodevelopmental disorders

pharmaphorum

Nicole Raleigh 30 June, 2025 Rare diseases Bookmark this News Moderna shines spotlight on new flu vaccine data Moderna may be facing regulatory uncertainty in the US for its vaccine pipeline, but at least its clinical data is hitting the right notes. Oncology The Leukemia & Lymphoma Society at ASCO 2025: Blood cancers.

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Planning, not panic, as BIO weighs in on US vaccination woes

pharmaphorum

BIO 2025 this year came at a uniquely fraught moment for vaccination in the United States just days after HHS Secretary Robert F Kennedy Jr. BIO 2025 this year came at a uniquely fraught moment for vaccination in the United States just days after HHS Secretary Robert F Kennedy Jr. The economics are there.