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RSS FeedPosted by Michael Wonder on 27 Mar 2026
Norgine announces Swissmedic approval of Pedmarqsi for the prevention of cisplatin induced hearing loss in children
26 March 2026 - The data from 2 open-label, randomised Phase 3 trials, SIOPEL 6 (pivotal) and the Clinical Oncology Group ...
Posted by Michael Wonder on 27 Mar 2026
MeiraGTx announces FDA breakthrough therapy designation for AAV2-hAQP1 for the treatment of grade 2 and grade 3 radiation-induced xerostomia
26 March 2026 - FDA granted breakthrough therapy designation for AAV2-hAQP1 for the treatment of Grade 2 and Grade 3 late ...
Posted by Michael Wonder on 27 Mar 2026
Eisai and Nuvation Bio announce marketing authorisation application for taletrectinib for the treatment of advanced ROS1 positive non-small cell lung cancer validated by the EMA
26 March 2026 - Additional filings are planned for the UK, Canada and other regions included in Eisai's licensed territories. ...
Posted by Michael Wonder on 27 Mar 2026
FDA approves first gene therapy for severe leukocyte adhesion deficiency type I
26 March 2026 - The US FDA today approved Kresladi (marnetegragene autotemcel), the first gene therapy for the treatment of severe ...
Posted by Michael Wonder on 26 Mar 2026
UCB receives positive CHMP opinion for new Zilbrysq (zilucoplan) pre-filled pen in EU for adults living with generalised myasthenia gravis
26 March 2026 - UCB today announced that the CHMP of the EMA has issued a positive opinion recommending a ...
Posted by Michael Wonder on 26 Mar 2026
Apotex expands Canadian ophthalmology portfolio with Health Canada's approval of Clobivis (clobetasol propionate ophthalmic suspension, 0.05%)
25 March 2026 - Apotex today announced that Health Canada has approved Clobivis (clobetasol propionate ophthalmic suspension, 0.05%), indicated for ...
Posted by Michael Wonder on 25 Mar 2026
Triana Biomedicines’ TRI-611 granted US FDA fast track designation for treatment of ALK positive non-small cell lung cancer
25 March 2026 - Triana Biomedicines today announced that the US FDA granted fast track designation for TRI-611, an investigational molecular ...
Posted by Michael Wonder on 25 Mar 2026
FDA approves drug to treat neurologic manifestations of Hunter syndrome
25 March 2026 - The US FDA approved Avlayah (tividenofusp alfa-eknm) to treat certain individuals with Hunter syndrome (mucopolysaccharidosis type II ...
Posted by Michael Wonder on 25 Mar 2026
Anavex Life Sciences provides update on regulatory review in the EU for blarcamesine to treat early Alzheimer’s disease
25 March 2026 - Anavex Life Sciences today announced that it has withdrawn its application for the marketing authorisation of ...
Posted by Michael Wonder on 25 Mar 2026
FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
25 March 2026 - Today, the FDA approved relacorilant (Lifyorli, Corcept Therapeutics), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel ...
Posted by Michael Wonder on 23 Mar 2026
Ionis announces zilganersen new drug application for Alexander disease accepted by FDA for priority review
23 March 2026 - Ionis Pharmaceuticals today announced that the US FDA has accepted for priority review the new drug application ...
Posted by Michael Wonder on 23 Mar 2026
EMA publishes agenda for 23-26 March 2026 CHMP meeting
23 March 2026 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 22 Mar 2026
IntraBio announces submission of supplemental new drug application for levacetylleucine for ataxia-telangiectasia
20 March 2026 - IntraBio today announced the submission of a supplemental new drug application to the US FDA for ...
Posted by Michael Wonder on 21 Mar 2026
Toward greater transparency at the FDA - now is the time to act
18 March 2026 - The US FDA has generally sought to uphold the highest standards of scientific rigour in its regulation ...
Posted by Michael Wonder on 20 Mar 2026
Political influence ‘a serious problem’ for FDA under Trump, former commissioner says
19 March 2026 - Political influence ‘a serious problem’ for FDA under Trump, former commissioner says. ...