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RSS FeedPosted by Michael Wonder on 21 May 2026
Neurofibromatosis patients push for adult reimbursement of Koselugo
19 May 2026 - Patients with neurofibromatosis are calling for insurance reimbursement to be expanded to adult patients for the ...
Posted by Michael Wonder on 20 May 2026
EMA publishes agenda for 18-21 May 2026 CHMP meeting
18 May 2026 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 20 May 2026
FDA official offers examples of RWE being used to secure drug approval
19 May 2026 - An official from the US FDA on Monday presented three case studies demonstrating how sponsors effectively ...
Posted by Michael Wonder on 20 May 2026
ImmunityBio announces FDA acceptance of supplemental BLA for Anktiva plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary disease
19 May 2026 - ImmunityBio today announced that the US FDA has accepted for review the supplemental biologics license application for ...
Posted by Michael Wonder on 20 May 2026
FDA accepts sNDA and grants priority review to Aqneursa for ataxia-telangiectasia
19 May 2026 - IntraBio today announced that the US FDA has accepted for review its supplemental new drug application ...
Posted by Michael Wonder on 20 May 2026
BioSyent announces Health Canada approval of Thyconvi (levothyroxine oral solution)
19 May 2026 - BioSyent announces that Health Canada has approved Thyconvi (levothyroxine sodium), the first and only levothyroxine oral ...
Posted by Michael Wonder on 20 May 2026
TrumpRx adds generic drugs, with Mark Cuban, GoodRx and Amazon
18 May 2026 - President Trump announced the addition of 600 medicines to his online drugstore as he appeals to Americans ...
Posted by Michael Wonder on 19 May 2026
US FDA accepts Viatris new drug application for fast-acting meloxicam for the treatment of moderate to severe acute pain
18 May 2026 - Viatris today announced that the US FDA has accepted for review the new drug application for ...
Posted by Michael Wonder on 19 May 2026
Bayer granted priority review by US FDA for asundexian in patients after a non-cardioembolic ischaemic stroke or transient ischaemic attack
19 May 2026 - Bayer today announced that the US FDA has accepted the company’s new drug application and granted priority ...
Posted by Michael Wonder on 19 May 2026
FDA approves Immgolis (golimumab-sldi) and Immgolis Intri (golimumab-sldi), first biosimilars to Simponi (golimumab) and Simponi Aria (golimumab)
18 May 2026 - Accord BioPharma announced today that the US FDA has approved Immgolis (golimumab-sldi), a biosimilar to Simponi ...
Posted by Michael Wonder on 19 May 2026
FDA grants breakthrough therapy designation to Vertanical's VER-01, a first in class non-opioid investigational treatment for chronic low back pain
18 May 2026 - Vertanical today announced that the US FDA has granted breakthrough therapy designation to VER-01, the company's ...
Posted by Michael Wonder on 18 May 2026
US FDA grants priority review to supplemental new drug application for Hyrnuo (sevabertinib) under investigation as a first-line treatment of HER2 mutated non-small cell lung cancer
18 May 2026 - Regulatory submission for first-line use of Hyrnuo is based on results from the on-going Phase I/II SOHO-01 ...
Posted by Michael Wonder on 18 May 2026
Baxfendy approved in the US as the first and only aldosterone synthase inhibitor treatment for adults with hypertension
18 May 2026 - Approval based on BaxHTN Phase 3 results showing statistically significant and clinically meaningful reduction in systolic blood ...
Posted by Michael Wonder on 18 May 2026
Pressure mounting to subsidise weight loss drugs
18 May 2026 - Two-thirds of Australian adults are overweight and many are at risk of heart failure. This plan could ...
Posted by Michael Wonder on 17 May 2026
New medicines may be out of reach of PBS patients as Australia fails to adapt to ‘seismic market shifts’
18 May 2026 - Donald Trump’s medicines prices policy is causing global market disruption even as Australia’s broken approval processes leave ...