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RSS FeedPosted by Michael Wonder on 28 May 2026
BridgeBio announces FDA acceptance and priority review of NDA for BBP-418 for LGMD2I/R9
27 May 2026 - BridgeBio Pharma today announced the FDA has accepted for filing its new drug application with priority review ...
Posted by Michael Wonder on 28 May 2026
Solu Therapeutics granted FDA fast track designation for STX-0712 for treatment of chronic myelomonocytic leukaemia
27 May 2026 - Solu Therapeutics today announced that the US FDA has granted fast track designation to STX-0712, the company's ...
Posted by Michael Wonder on 27 May 2026
Outlook Therapeutics wins appeal following formal dispute resolution process for ONS-5010/Lytenava (bevacizumab-vikg) company plans to resubmit BLA to the FDA in June 2026
26 May 2026 - Outlook Therapeutics today announced that the US FDA has granted the appeal following completion of the ...
Posted by Michael Wonder on 27 May 2026
FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy
27 May 2026 - Today, the FDA approved pivekimab sunirine-pvzy (Decnupaz, AbbVie), a CD123-directed antibody and alkylating agent conjugate, for ...
Posted by Michael Wonder on 27 May 2026
US FDA decision date extended for SERENA-6 filing of camizestrant to enable review of additional data
27 May 2026 - The US FDA has informed AstraZeneca that it will extend the PDUFA date to review additional data ...
Posted by Michael Wonder on 27 May 2026
Dyne Therapeutics announces submission of biologics license application to US FDA for z-rostudirsen in exon 51 Duchenne muscular dystrophy
26 May 2026 - Submission for accelerated approval based on dystrophin as a surrogate outcome. ...
Posted by Michael Wonder on 27 May 2026
Apotex expands ophthalmic portfolio with Health Canada approval of Iheezo
26 May 2026 - Apotex today announced that Health Canada has approved Iheezo (chloroprocaine hydrochloride ophthalmic gel 3%), a topical ...
Posted by Michael Wonder on 27 May 2026
Pfizer's Braftovi becomes first Pfizer therapy to receive priority access under Ontario's FAST program, accelerating treatment for Canadians with metastatic colorectal cancer
26 May 2026 - Pfizer Canada announces that Braftovi (encorafenib) will be funded under Ontario's Funding Accelerated for Specific Treatments ...
Posted by Michael Wonder on 27 May 2026
ICER to assess treatments for Friedreich’s ataxia
26 May 2026 - Report will be subject of New England CEPAC meeting in January 2027; draft scoping document open ...
Posted by Michael Wonder on 27 May 2026
Autobahn Therapeutics announces US FDA fast track designation for elunetirom, a CNS directed thyroid hormone receptor agonist, for the adjunctive treatment of bipolar depression
26 May 2026 - Autobahn Therapeutics today announced that the US FDA granted fast track designation to elunetirom, the Company’s lead ...
Posted by Michael Wonder on 26 May 2026
Avanzanite Bioscience’s partner Agios announces Pyrukynd (mitapivat) approval in the European Union for adults with thalassaemia
22 May 2026 - Avanzanite Bioscience today reported that its partner, Agios Pharmaceuticals announced that the European Commission has granted marketing ...
Posted by Michael Wonder on 25 May 2026
First medicine to treat rare uncontrolled growth of body tissues
22 May 2026 - Vijoice addresses an unmet medical need for patients with severe or life-threatening PIK3CA-related overgrowth spectrum disorders. ...
Posted by Michael Wonder on 25 May 2026
New medicine for two types of pulmonary fibrosis
22 May 2026 - Jascayd slowed loss of lung function in patients with idiopathic or progressive pulmonary fibrosis. ...
Posted by Michael Wonder on 25 May 2026
First oral GLP-1 treatment for weight management
22 May 2026 - EMA has recommended an extension to the marketing authorisation for Wegovy (semaglutide) in the EU to add ...
Posted by Michael Wonder on 25 May 2026
Novo’s Sogroya gets Korea reimbursement for growth hormone deficiency
22 May 2026 - Novo Nordisk Pharma Korea said Thursday its once weekly growth hormone therapy Sogroya has received national ...