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RSS FeedPosted by Michael Wonder on 18 Jun 2025
Cancer inhibitors scrapped from basic insurance for some users
18 June 2025 - National health care institute Zorginstituut Nederland has scrapped several cancer inhibiting drugs from the basic health ...
Posted by Michael Wonder on 27 Dec 2023
Amgen provides regulatory update on the status of Lumakras (sotorasib)
26 December 2023 - FDA has issued a new post-marketing requirement. ...
Posted by Michael Wonder on 27 Dec 2023
Scilex announces filing of a new drug submission to Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for the approval of Elyxyb for acute treatment of migraine with or without aura in Canada
26 December 2023 - The anticipated timeline for approval in Canada is approximately 12 months depending on review cycles and ...
Posted by Michael Wonder on 26 Dec 2023
US Food and Drug Administration issues complete response letter for dasiglucagon in congenital hyperinsulinism for up to three weeks of dosing due to inspection findings at third-party manufacturing facility
23 December 2023 - The CRL is related to deficiencies identified at a third-party manufacturing facility following an inspection but are ...
Posted by Michael Wonder on 24 Dec 2023
AstraZeneca cancer drug Calquence cost tumbles with PBS listing
23 December 2023 - An AstraZeneca drug’s listing on the PBS from January 1 will see bills fall massively for people ...
Posted by Michael Wonder on 23 Dec 2023
Patritumab deruxtecan granted priority review in the US for certain patients with previously treated locally advanced or metastatic EGFR mutated non-small-cell lung cancer
22 December 2023 - Submission based on HERTHENA-Lung01 results showing patritumab deruxtecan demonstrated clinically meaningful and durable responses in patients ...
Posted by Michael Wonder on 23 Dec 2023
Cidara Therapeutics announces European Approval of Rezzayo (rezafungin) for the treatment of invasive candidiasis in adults
22 December 2023 - Approval based on positive results from the pivotal ReSTORE Phase 3 clinical trial and supported by the ...
Posted by Michael Wonder on 23 Dec 2023
Sarepta Therapeutics submits efficacy supplement to expand the Elevidys label to include Duchenne muscular dystrophy patients without restriction to age or ambulatory status
22 December 2023 - Sarepta has also submitted the EMBARK post-marketing requirement to the FDA seeking conversion of the Elevidys accelerated ...
Posted by Michael Wonder on 23 Dec 2023
Zealand Pharma submits new drug application to the US FDA for glepaglutide in short bowel syndrome
22 December 2023 - Zealand Pharma today announced the submission of a new drug application to the US FDA for glepaglutide, ...
Posted by Michael Wonder on 22 Dec 2023
Centralised marketing authorisations of generic versions of Tecfidera are revoked by the European Commission
19 December 2023 - Biogen today announced that the European Commission has revoked the centralised marketing authorizations for generic versions ...
Posted by Michael Wonder on 22 Dec 2023
BioNTech and DualityBio receive FDA breakthrough therapy designation for antibody drug conjugate candidate BNT323/DB-1303 in endometrial cancer
21 December 2023 - Designation is based on Phase 1/2 safety and efficacy data in patients with HER2 expressing advanced endometrial ...
Posted by Michael Wonder on 22 Dec 2023
Wainua (eplontersen) granted first ever regulatory approval in the US for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis
21 December 2023 - US FDA approval based on NEURO-TTRansform Phase 3 results showing Wainua demonstrated consistent and sustained benefit improving ...
Posted by Michael Wonder on 22 Dec 2023
PBS Expenditure and Prescriptions Report 2022-23
22 December 2023 - The PBS Expenditure and Prescriptions Report 1 July 2022 to 30 June 2023 is now available. ...
Posted by Michael Wonder on 22 Dec 2023
Takeda announces China NMPA approval of Livtencity (maribavir) for the treatment of adults with post-transplant cytomegalovirus refractory to prior therapies
21 December 2023 - Approval based on Phase 3 TAK-620-303 SOLSTICE study demonstrating maribavir was superior to conventional therapies at week ...
Posted by Michael Wonder on 22 Dec 2023
Keytruda (pembrolizumab) plus Lenvima (lenvatinib) receive public listing for patients with advanced endometrial carcinoma that is not MSI-H or dMMR
21 December 2023 - Merck and Eisai announce that Keytruda plus Lenvima, is now reimbursed with clinical criteria and conditions ...
Posted by Michael Wonder on 21 Dec 2023
Merry Christmas and a Happy New Year to all
22 December 2023 - Merry Christmas to all MAESTrO Daily readers. ...