Blog
RSS FeedPosted by Michael Wonder on 01 Apr 2024
Voydeya approved in the US as add-on therapy to ravulizumab or eculizumab for treatment of extravascular haemolysis in adults with the rare disease PNH
1 April 2024 - Approval of first in class, oral, Factor D inhibitor based on results from pivotal ALPHA Phase ...
Posted by Michael Wonder on 30 Mar 2024
FDA Approves Medexus's supplemental biologics license application for Ixinity to treat haemophilia B in paediatric patients
26 March 2024 - Expanded indication includes patients under 12 years of age, based on Phase 3/4 data demonstrating safety and ...
Posted by Michael Wonder on 29 Mar 2024
Paladin Labs announces approval of Wakix (pitolisant hydrochloride tablets) for use in paediatric patients in Canada
28 March 2024 - Indication includes children ages 6 years and older and weighing at least 30 kg. ...
Posted by Michael Wonder on 28 Mar 2024
Abilify Maintena 960 mg (aripiprazole) approved in the EU as the first once every two months long-acting injectable for the maintenance treatment of schizophrenia
27 March 2024 - Otsuka Pharmaceutical announces that its subsidiary Otsuka Pharmaceutical Europe and Lundbeck announced that the European Commission ...
Posted by Michael Wonder on 28 Mar 2024
European Commission approves Merck’s Keytruda (pembrolizumab) plus chemotherapy as neo-adjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer at high risk of recurrence in adults
28 March 2024 - Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable non-small cell lung ...
Posted by Michael Wonder on 28 Mar 2024
Akebia receives FDA approval of Vafseo (vadadustat) tablets for the treatment of anaemia due to chronic kidney disease in adult patients on dialysis
27 March 2024 - Once daily oral HIF-PH inhibitor activates physiologic response to manage anaemia. ...
Posted by Michael Wonder on 27 Mar 2024
Norgine receives positive CHMP opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment of malignant hyperthermia
26 March 2024 - Norgine today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of ...
Posted by Michael Wonder on 26 Mar 2024
FDA approves Merck’s Winrevair (sotatercept-csrk), a first in class treatment for adults with pulmonary arterial hypertension (WHO Group 1)
26 March 2024 - Winrevair on top of background therapy significantly improved exercise capacity and multiple important secondary outcome measures ...
Posted by Michael Wonder on 25 Mar 2024
Regeneron provides update on biologics license application for odronextamab
25 March 2024 - Regeneron Pharmaceuticals today announced that the US FDA has issued complete response letters for the biologics license ...
Posted by Michael Wonder on 25 Mar 2024
Ultomiris approved in the US for the treatment of adults with neuromyelitis optica spectrum disorder
25 March 2024 - Unprecedented relapse risk reduction observed in CHAMPION-NMOSD trial underscores how Ultomiris may redefine patient journey for ...
Posted by Michael Wonder on 25 Mar 2024
US FDA approves Opsynvi (macitentan and tadalafil) as the first and only once daily single tablet combination therapy for patients with pulmonary arterial hypertension
22 March 2024 - Approval is based on the results from the pivotal Phase 3 A DUE study, which met ...
Posted by Michael Wonder on 25 Mar 2024
US FDA approves broad new labels for Esperion’s Nexletol and Nexlizet to prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, regardless of statin use
22 March 2024 - Esperion today announced that the US FDA has approved broad new label expansions for Nexletol (bempedoic acid) ...
Posted by Michael Wonder on 24 Mar 2024
Highlights from the 18-21 March 2024 CHMP meeting
22 March 2024 - The EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting. ...
Posted by Michael Wonder on 23 Mar 2024
FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
22 March 2024 - Today, the FDA approved mirvetuximab soravtansine-gynx (Elahere, ImmunoGen) for adult patients with FRα positive, platinum-resistant epithelial ...
Posted by Michael Wonder on 22 Mar 2024
Astellas receives positive CHMP opinion for Xtandi in additional recurrent early prostate cancer treatment setting
22 March 2024 - If approved, XTANDI would become the first and only NHT treatment available for metastatic and high risk ...