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RSS FeedPosted by Michael Wonder on 28 Mar 2026
Egetis announces FDA acceptance and priority review of NDA for Emcitate (tiratricol) for MCT8 feficiency
27 March 2026 - Egetis Therapeutics today announced that the US FDA has accepted the filing of its new drug application ...
Posted by Michael Wonder on 28 Mar 2026
The potential loophole in Trump’s plan to get other countries to pay more for drugs
24 March 2026 - Comments from a top health official point to a big issue. ...
Posted by Michael Wonder on 28 Mar 2026
Bepirovirsen accepted for review by the EMA as a potential first in class treatment for chronic hepatitis B
27 March 2026 - Submission supported by statistically significant and clinically meaningful functional cure rates in pivotal PhIII B-Well trials. ...
Posted by Michael Wonder on 27 Mar 2026
Awiqli approved in the US, the first and only once weekly basal insulin treatment for adults with type 2 diabetes
27 March 2026 - Novo Nordisk expects to launch Awiqli nationwide in the US in the second half of 2026. ...
Posted 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
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 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
ICER launches program to accelerate the consideration of value into drug development programs
25 March 2026 - ICER will leverage its health technology assessment expertise to encourage better evidence development in clinical trial ...
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 25 Mar 2026
Agenda for the July 2026 PBAC meeting (25 March 2026)
25 March 2026 - The agenda for the July 2026 PBAC meeting is now available. ...
Posted by Michael Wonder on 25 Mar 2026
New public listings for Canadians living with pulmonary arterial hypertension
24 March 2026 - Merck announced today that British Columbia, Non-Insured Health Benefits (NIHB), Nova Scotia, Quebec and Veterans Affairs Canada ...