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RSS FeedPosted by Michael Wonder on 22 May 2026
The EMA accepts Teva’s marketing authorisation application for olanzapine long-acting injectable for the treatment of schizophrenia in adults
21 May 2026 - Teva Pharmaceuticals and Medincell today announced that the EMA has accepted the marketing authorisation application for olanzapine ...
Posted by Michael Wonder on 22 May 2026
FDA approves new Guardant360 Liquid CDx, the largest FDA approved liquid biopsy panel with a 100x expanded footprint
20 May 2026 - Guardant Health today announced that the US FDA has approved Guardant360 Liquid CDx, advancing blood-based comprehensive genomic ...
Posted by Michael Wonder on 21 May 2026
Allergan Aesthetics receives positive CHMP opinion for Boey (trenibotulinumtoxinE) for the temporary improvement of moderate to severe glabellar lines in adults
21 May 2026 - Positive opinion is supported by data from two pivotal Phase 3 trials, which demonstrated rapid results as ...
Posted by Michael Wonder on 21 May 2026
Bayer’s Kerendia (finerenone) granted priority review of supplemental new drug application by US FDA for treatment of adults with type 1 diabetes and chronic kidney disease
21 May 2026 - Bayer announced today that the US FDA accepted its supplemental new drug application and granted priority review ...
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 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 ...