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RSS FeedPosted by Michael Wonder on 28 Mar 2025
Fresenius receives FDA approval for their denosumab biosimilars and secures global settlement agreement
27 March 2025 - Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) received FDA approval for all indications of the reference products: Prolia (denosumab) ...
Posted by Michael Wonder on 27 Mar 2025
Chlamydia vaccine candidate granted fast track designation by the US FDA
26 March 2025 - The US FDA has granted fast track designation to Sanofi’s mRNA vaccine candidate for the prevention of ...
Posted by Michael Wonder on 27 Mar 2025
Savara completes submission of the biologics license application to the US FDA for Molbreevi as a treatment for auto-immune pulmonary alveolar proteinosis
26 March 2025 - Priority review was requested, commercial launch preparations ynderway. ...
Posted by Michael Wonder on 27 Mar 2025
FDA approves cabozantinib for adults and paediatric patients 12 years of age and older with pNET and epNET
26 March 2025 - Today, the FDA approved cabozantinib (Cabometyx, Exelixis) for adult and paediatric patients 12 years of age ...
Posted by Michael Wonder on 26 Mar 2025
Theratechnologies receives FDA approval for Egrifta WR (tesamorelin F8) to treat excess visceral abdominal fat in adults with HIV and lipodystrophy
25 March 2025 - New, improved formulation set to replace Egrifta SV. ...
Posted by Michael Wonder on 26 Mar 2025
FDA grants priority review for biologics license application and EMA accepts marketing authorisation application for apitegromab as a treatment for spinal muscular atrophy
25 March 2025 - FDA to review BLA application under priority review, with a PDUFA date of 22 September 2025. ...
Posted by Michael Wonder on 26 Mar 2025
Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections in female adults and paediatric patients 12 years of age and older
25 March 2025 - Blujepa is the first in a new class of oral antibiotics for uUTIs in nearly 30 ...
Posted by Michael Wonder on 26 Mar 2025
Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis
25 March 2025 - Tolebrutinib was granted breakthrough therapy designation by the FDA based on positive results from the HERCULES Phase ...
Posted by Michael Wonder on 25 Mar 2025
Sungen Biomedical's world first new drug SGC001 monoclonal antibody receives FDA fast track approval
24 March 2025 - On 17 March 2025, US time, the world's first acute myocardial infarction antibody drug, SGC001, developed by ...
Posted by Michael Wonder on 23 Mar 2025
FDA approves new prostate cancer imaging agent Gozellix
21 March 2025 - Telix Pharmaceuticals today announces that the US FDA has approved its new drug application for Gozellix ...
Posted by Michael Wonder on 21 Mar 2025
Novartis receives third FDA approval for oral Fabhalta (iptacopan) – the first and only treatment approved in C3 glomerulopathy
20 March 2025 - Phase 3 study showed sustained proteinuria reduction at one year with favourable safety. ...
Posted by Michael Wonder on 21 Mar 2025
Alnylam announces FDA approval of Amvuttra (vutrisiran), the first RNAi therapeutic to reduce cardiovascular death, hospitalisations and urgent heart failure visits in adults with ATTR amyloidosis with cardiomyopathy
20 March 2025 - Only therapeutic approved in the US to address both cardiomyopathy and polyneuropathy manifestations of ATTR amyloidosis. ...
Posted by Michael Wonder on 21 Mar 2025
US FDA approves Tremfya (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn’s disease
20 March 2025 - Supported by data from the GALAXI study, Tremfya is the only IL-23 inhibitor to show superiority versus ...
Posted by Michael Wonder on 21 Mar 2025
Secretome Therapeutics granted FDA fast track designation for STM-01, a neonatal cardiac progenitor cell therapy for HFpEF
20 March 2025 - Secretome Therapeutics today announced that the US FDA has granted fast track designation to STM-01, the company’s ...
Posted by Michael Wonder on 20 Mar 2025
FDA approves pembrolizumab for HER2 positive gastric or gastro-oesophageal junction adenocarcinoma expressing PD-L1
19 March 2025 - Today, the FDA granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy ...