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RSS FeedPosted by Michael Wonder on 22 Apr 2026
Biocon receives Health Canada approval of Bosaya (denosumab) and Vevzuo (denosumab), biosimilars to Prolia and Xgeva
21 April 2026 - Biocon is pleased to announce that Health Canada has granted a Notice of Compliance for Bosaya (denosumab), ...
Posted by Michael Wonder on 22 Apr 2026
Moderna receives European Commission marketing authorisation for mCOMBRIAX, Moderna's mRNA combination vaccine against influenza and COVID-19
21 April 2026 - mCOMBRIAX will be made available in the European Union, subject to national regulatory and access procedures ...
Posted by Michael Wonder on 21 Apr 2026
FDA approves Merck’s once daily Idvynso (doravirine/islatravir)
21 April 2026 - Idvynso is the first and only non-INSTI, tenofovir free, once daily, complete two drug regimen to ...
Posted by Michael Wonder on 21 Apr 2026
FDA grants priority review for Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each with Padcev (enfortumab vedotin-ejfv), for cisplatin-eligible patients with muscle invasive bladder cancer
20 April 2026 - Merck today announced that the US FDA granted priority review for two supplemental biologics license applications for ...
Posted by Michael Wonder on 21 Apr 2026
FDA accepts application for Genentech’s Gazyva for the treatment of the most common form of lupus
20 April 2026 - Filing acceptance based on Phase 3 ALLEGORY data for Gazyva showing a significant reduction in disease activity ...
Posted by Michael Wonder on 21 Apr 2026
European Commission approves Merck’s Enflonsia (clesrovimab) for the prevention of respiratory syncytial virus lower respiratory tract disease in infants during their first RSV season
17 April 2026 - Merck announced today that the European Commission has approved Enflonsia (clesrovimab) for the prevention of respiratory syncytial ...
Posted by Michael Wonder on 21 Apr 2026
EMA validates type II variation application for Padcev (enfortumab vedotin) plus Keytruda (pembrolizumab) in cisplatin-eligible patients with muscle invasive bladder cancer
23 March 2026 - Astellas today announced that the European Medicines Agency (EMA) has validated for review a Type II ...
Posted by Michael Wonder on 21 Apr 2026
First FDA approved treatment for patients with focal segmental glomerulosclerosis—a rare kidney condition
16 April 2026 - The US FDA on Monday approved a new indication for Filspari (sparsentan) tablets for reducing proteinuria in ...
Posted by Michael Wonder on 21 Apr 2026
US FDA grants priority review to sBLA for Padcev and Keytruda as peri-operative treatment for muscle invasive bladder cancer regardless of cisplatin eligibility
20 April 2026 - Astellas Pharma and Pfizer announced that the US FDA accepted for triority review a supplemental biologics license ...
Posted by Michael Wonder on 19 Apr 2026
Aicuris receives FDA priority review for pritelivir NDA
16 April 2026 - 26 - Aicuris Anti-infective Cures today announced that the US FDA has granted priority review for the ...
Posted by Michael Wonder on 18 Apr 2026
Bracco receives Health Canada approval for Vueway injection (gadopiclenol), advancing lower dose MRI contrast imaging
17 April 2026 - Approval marks a major milestone in reducing gadolinium exposure while maintaining diagnostic performance, aligning with clinical guidance ...
Posted by Michael Wonder on 16 Apr 2026
Savara announces the US FDA has extended the review period for the molgramostim inhalation solution biologics license application in autoimmune pulmonary alveolar proteinosis
15 April 2026 - Savara today announced that the FDA has extended the review period for the molgramostim BLA in ...
Posted by Michael Wonder on 16 Apr 2026
Health Canada approves Cysklar (cysteamine ophthalmic solution) 0.44% for treatment of corneal crystals in people with cystinosis
15 April 2026 - Leadiant Biosciences today announced that Health Canada has approved Cysklar (cysteamine ophthalmic solution) 0.44%, a topical eye ...
Posted by Michael Wonder on 16 Apr 2026
Health Canada approves neffy - the first needle free epinephrine spray for anaphylaxis
15 April 2026 - ALK-Abello today announced that Health Canada has approved neffy 2 mg for the emergency treatment of ...
Posted by Michael Wonder on 15 Apr 2026
Partner Therapeutics announces submission of supplemental biologics license application to FDA for Bizengri (zenocutuzumab-zbco) in NRG1 fusion positive cholangiocarcinoma
14 April 2026 - Partner Therapeutics announces the submission of a supplemental biologics license application to the US FDA for Bizengri ...