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RSS FeedPosted by Michael Wonder on 14 Mar 2024
European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease
13 March 2024 - Prevenar 20 (20 valent pneumococcal conjugate vaccine) offers the broadest serotype coverage of any paediatric pneumococcal ...
Posted by Michael Wonder on 13 Mar 2024
Sumitomo Pharma announces availability of Orgovyx (relugolix) in Canada, the first and only oral androgen deprivation therapy treatment for men with advanced prostate cancer
12 March 2024 - Sumitomo Pharma announced today that Orgovyx (relugolix), an oral gonadotropin-releasing hormone receptor antagonist, is now available for ...
Posted by Michael Wonder on 12 Mar 2024
Johnson & Johnson submits supplemental biologics license application to US FDA seeking approval of Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis
11 March 2024 - Submission is supported by data from the Phase 3 QUASAR program, which showed a significantly greater percentage ...
Posted by Michael Wonder on 12 Mar 2024
Travere Therapeutics submits supplemental new drug application to the US FDA seeking full approval of Filspari (sparsentan) for the treatment of IgA nephropathy
11 March 2024 - Submission is based on 2 year confirmatory results from the Phase 3 PROTECT study in which Filspari ...
Posted by Michael Wonder on 12 Mar 2024
Viatris and Mapi Pharma statement regarding new drug application for glatiramer acetate depot
11 March 2024 - Viatris has been informed that Mapi Pharma has received a complete response letter regarding the new drug ...
Posted by Michael Wonder on 11 Mar 2024
Praluent (alirocumab) injection receives FDA approval to treat children with genetic form of high cholesterol
11 March 2024 - Approval extends treatment of Praluent to children aged 8 and older with heterozygous familial hypercholesterolaemia. ...
Posted by Michael Wonder on 11 Mar 2024
Celltrion USA completes submission of biologics license application to US FDA for CT-P39, an interchangeable biosimilar candidate of Xolair (omalizumab)
10 March 2024 - The BLA for CT-P39 was based on totality of evidence including results from Phase III data ...
Posted by Michael Wonder on 09 Mar 2024
Fresenius Kabi’s biosimilar Tyenne (tocilizumab-aazg) becomes the first intravenous and subcutaneous tocilizumab biosimilar approved by the FDA
7 March 2024 - Fresenius Kabi announced today that the US FDA has approved Tyenne (tocilizumab-aazg), its tocilizumab biosimilar referencing Actemra ...
Posted by Michael Wonder on 08 Mar 2024
FDA approves first treatment to reduce risk of serious heart problems specifically in adults with obesity or overweight
8 March 2024 - Today, the US FDA approved a new indication for use for Wegovy (semaglutide) injection to reduce the ...
Posted by Michael Wonder on 08 Mar 2024
MindMed receives FDA breakthrough therapy designation for MM120 for generalized anxiety disorder
7 March 2024 - Mind Medicine today announced that FDA has granted breakthrough designation to its MM120 (lysergide d-tartrate) program for ...
Posted by Michael Wonder on 07 Mar 2024
FDA grants accelerated approval to zanubrutinib for relapsed or refractory follicular lymphoma
7 March 2024 - Today, the FDA granted accelerated approval to zanubrutinib (Brukinsa, BeiGene) with obinutuzumab for relapsed or refractory ...
Posted by Michael Wonder on 07 Mar 2024
FDA approves nivolumab in combination with cisplatin and gemcitabine for unresectable or metastatic urothelial carcinoma
7 March 2024 - On 6 March 2024, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) in combination with cisplatin and gemcitabine ...
Posted by Michael Wonder on 07 Mar 2024
Johnson & Johnson submits application to the EMA for Darzalex (daratumumab)-based quadruplet therapy for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma
6 March 2024 - Submission supported by data from Phase 3 PERSEUS study, which showed the daratumumab subcutaneous formulation-based regimen significantly ...
Posted by Michael Wonder on 06 Mar 2024
Trellis Bioscience's TRL1068 receives FDA fast track and QIDP designations, amplifying commitment to combat infectious diseases
6 March 2024 - Trellis Bioscience is thrilled to announce that its lead antibody candidate, TRL1068, has been granted fast ...
Posted by Michael Wonder on 06 Mar 2024
FDA approves inotuzumab ozogamicin for paediatric patients with acute lymphoblastic leukaemia
6 March 2024 - Today, the FDA approved inotuzumab ozogamicin (Besponsa, Pfizer) for paediatric patients 1 year and older with ...