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RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 30 Dec 2020
Tiered drug pricing policy widens price difference among generic drugs
30 December 2020 - In July, the nation implemented a “tiered system” to restructure the drug-pricing method, which called for ...
Posted by Michael Wonder on 30 Dec 2020
Bristol Myers Squibb statement on Opdivo (nivolumab) small cell lung cancer U.S. indication
29 December 2020 - In 2018, Opdivo (nivolumab) was granted accelerated approval by the U.S. FDA for the treatment of patients ...
Posted by Michael Wonder on 30 Dec 2020
Zai Lab announces inclusion of Zejula (niraparib) in China’s National Reimbursement Drug List
28 December 2020 - Zai Lab today announced that Zejula has been included in the updated National Reimbursement Drug List released ...
Posted by Michael Wonder on 30 Dec 2020
BeiGene announces inclusion of three innovative oncology products in China National Reimbursement Drug List
27 December 2020 - Internally-developed anti-PD-1 antibody tislelizumab and BTK inhibitor Brukinsa (zanubrutinib) are included in the National Reimbursement Drug List ...
Posted by Michael Wonder on 30 Dec 2020
Junshi Biosciences announces inclusion of toripalimab in the China National Reimbursement Drug List
29 December 2020 - Junshi Biosciences is pleased to announce that toripalimab has been included in the updated National Reimbursement Drug ...
Posted by Michael Wonder on 30 Dec 2020
Osmotica Pharmaceuticals receives complete response letter from U.S. Food and Drug Administration for arbaclofen extended release tablets
29 December 2020 - Osmotica Pharmaceuticals today announced that the U.S. FDA has issued a complete response letter regarding the Company's ...
Posted by Michael Wonder on 30 Dec 2020
AstraZeneca’s COVID-19 vaccine authorised for emergency supply in the UK
30 December 2020 - Regulatory interactions continue around the world for next approvals. ...
Posted by Michael Wonder on 30 Dec 2020
Novo Nordisk files for EU regulatory approval of once weekly semaglutide 2 mg for the treatment of type 2 diabetes mellitus
29 December 2020 - Novo Nordisk today announced the submission of a label extension application to the EMA for the existing ...
Posted by Michael Wonder on 30 Dec 2020
Eyenovia submits new drug application to FDA for pharmacologic mydriasis with MydCombi targeting 80 million patient encounters in the U.S. annually
29 December 2020 - Eyenovia today announced that it has submitted a new drug application to the U. S. FDA ...
Posted by Michael Wonder on 29 Dec 2020
FDA accepts Alkermes' resubmission of new drug application for ALKS 3831
29 December 2020 - FDA sets PDUFA target action date of 1 June 2021. ...
Posted by Michael Wonder on 29 Dec 2020
Vertex announces new drug submission for investigational triple combination medicine for the treatment of cystic fibrosis has been accepted for priority review by Health Canada
28 December 2020 - Vertex Pharmaceuticals Incorporated today announced its New Drug Submission for Trikafta, Vertex’s investigational triple combination medicine, ...
Posted by Michael Wonder on 29 Dec 2020
Y-mAbs announces sale of priority review voucher
28 December 2020 - Y-mAbs Therapeutics today announced that it has entered into a definitive agreement to sell its priority ...
Posted by Michael Wonder on 29 Dec 2020
European Medicines Agency validates Bristol Myers Squibb’s application for Zeposia (ozanimod) for the treatment of ulcerative colitis
28 December 2020 - Marketing authorisation application is supported by positive results from the pivotal Phase 3 True North trial evaluating ...
Posted by Michael Wonder on 29 Dec 2020
Janssen submits European marketing authorisation application for amivantamab for the treatment of patients with metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
28 December 2020 - If approved, amivantamab will be the first-ever treatment specifically targeting EGFR exon 20 insertion mutations in the ...
Posted by Michael Wonder on 29 Dec 2020
Lorbrena (lorlatinib) supplementary new drug application in previously untreated ALK positive lung cancer accepted for priority review by U.S. FDA
28 December 2020 - Supplemental new drug application being reviewed under FDA Real-Time Oncology Review and Project ORBIS pilot programs. ...