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RSS FeedPosted by Michael Wonder on 29 Mar 2025
FDA approves durvalumab for muscle invasive bladder cancer
28 March 2025 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neo-adjuvant treatment, followed by ...
Posted by Michael Wonder on 29 Mar 2025
FDA approves novel treatment for haemophilia A or B, with or without factor inhibitors
28 March 2025 - Medication can be given up to once every 2 months. ...
Posted by Michael Wonder on 28 Mar 2025
Crinetics Pharmaceuticals announces EMA validation of marketing authorisation application and orphan drug designation for paltusotine in acromegaly
27 March 2025 - Crinetics Pharmaceuticals today announced that the EMA has validated the marketing authorisation application for paltusotine, the ...
Posted by Michael Wonder on 28 Mar 2025
Richter announces submission to EMA for biosimilar tocilizumab in multiple indications
27 March 2025 - Gedeon Richter announces today that the EMA has accepted Richter’s marketing authorisation application for its proposed biosimilar ...
Posted by Michael Wonder on 28 Mar 2025
Neurim Pharmaceuticals receives European marketing authorisation for paediatric prolonged-release melatonin (Slenyto) for the treatment of insomnia in children with ADHD
26 March 2025 - Neurim Pharmaceuticals announces that the European Commission has approved the extension of the indication to include ...
Posted 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
EMA publishes agenda for 24-27 March 2025 CHMP meeting
24 March 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 27 Mar 2025
ICER publishes evidence report on treatment for retinitis pigmentosa
26 March 2025 - There are significant uncertainties regarding long term efficacy and durability of sonpiretigene isteparvovec; ICER estimates that ...
Posted by Michael Wonder on 27 Mar 2025
ViiV Healthcare announces reimbursement for Apretude for HIV-1 pre-exposure prophylaxis under the Non-Insured Health Benefits (NIHB) Program
25 March 2025 - ViiV Healthcare is pleased to announce that Apretude (cabotegravir tablets and extended release injectable suspension) is ...
Posted by Michael Wonder on 27 Mar 2025
American pharmaceutical boss does not support tariffs on Australian medicines
26 March 2025 - The head of one of America's largest pharmaceutical companies says he does not support tariffs on ...
Posted by Michael Wonder on 27 Mar 2025
New and expanded cheaper medicines
27 March 2025 - Australians with Cushing’s syndrome, retinal vein occlusion and psoriatic arthritis, leukaemia, and women needing contraception and menopause ...
Posted by Michael Wonder on 27 Mar 2025
Soleno Therapeutics announces US FDA approval of Vykat XR to treat hyperphagia in Prader-Willi syndrome
26 March 2025 - First approved therapy to address hyperphagia in individuals with Prader-Willi syndrome. ...
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. ...