FDA Delays PDUFA Action on Agios’ Mitapivat sNDA for SCD
The FDA has delayed a decision on Agios Pharmaceuticals’ supplemental New Drug Application (sNDA) seeking…
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AstraZeneca Restructures, Alnylam Faces Challenges, Regeneron Reports Success
AstraZeneca is set to redeploy resources as part of a new restructuring program aimed at…
FDA Issues Revised Guidance on Drug Delivery Devices
The FDA has announced a revised draft guidance for industry titled “Essential Drug Delivery Performance…
Neuralink’s Blindsight Vision Implant Faces Clinical Readiness Questions
Neuralink’s plans for a brain implant designed to restore vision have gained attention following a…
Fresenius Expands Biosimilars Pipeline with WuXi Biologics Partnership
Fresenius is expanding its biosimilars strategy through an exclusive development agreement with WuXi Biologics that…
Buccal Drug Delivery Market Expected to Grow Significantly
The global market for buccal drug delivery systems is projected to maintain strong growth through…
Inovio’s Voceryq Receives FDA Accelerated Approval
Inovio has secured accelerated approval from the FDA for Voceryq to minimise the frequency of…
MHRA Promotes Yellow Card Reporting for MedSafetyWeek
The MHRA is encouraging patients, parents, carers, and healthcare professionals to report suspected side effects…
Kymera’s eczema trial readout could rival Dupixent
Kymera Therapeutics is set to announce data from a mid-stage clinical trial of its lead…
Gene Editing Stocks Surge on FDA Guidance and ESGCT Data
Shares of gene editing therapy companies surged by double digits recently, driven by two key…