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RSS FeedPosted by Michael Wonder on 27 May 2025
Teva celiac disease candidate granted fast track designation by US FDA
27 May 2025 - Designation underscores the potential of TEV-53408, currently undergoing a Phase 2a study for the treatment of celiac ...
Posted by Michael Wonder on 27 May 2025
BeiGene receives positive CHMP opinion for Tevimbra as a first-line treatment for nasopharyngeal cancer
27 May 2025 - Positive opinion for Tevimbra in combination with chemotherapy as a first-line treatment of nasopharyngeal cancer based ...
Posted by Michael Wonder on 27 May 2025
ICER releases draft evidence report on treatments for spinal muscular atrophy
27 May 2025 - Public comment period now open until 24 June 2025; requests to make oral comment during public ...
Posted by Michael Wonder on 27 May 2025
Savara receives refusal to file letter from the US FDA for the biologics license application for Molbreevi to treat patients with auto-immune pulmonary alveolar proteinosis
27 May 2025 - Savara today announced that the Company received a refusal to file letter from the FDA for ...
Posted by Michael Wonder on 27 May 2025
Imfinzi recommended for approval in the EU by CHMP as first and only peri-operative immunotherapy for muscle-invasive bladder cancer
27 May 2025 - Recommendation based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of ...
Posted by Michael Wonder on 27 May 2025
Arcutis’ Zoryve (roflumilast) 0.3% topical foam approved by US FDA for the treatment of plaque psoriasis in adults and adolescents ages 12 and older
22 May 2025 - Fifth FDA approval for Zoryve in less than three years. ...
Posted by Michael Wonder on 27 May 2025
Eylea 8 mg with extended 6 month treatment interval recommended for approval in EU
23 May 2025 - CHMP opinion is based on the findings from the pivotal clinical trials PULSAR in neovascular (wet) ...
Posted by Michael Wonder on 27 May 2025
GSK's depemokimab accepted for review by Health Canada for the treatment of asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps
26 May 2025 - GSK has submitted a new drug submission to Health Canada for depemokimab for two proposed indications: the ...
Posted by Michael Wonder on 27 May 2025
Schedule rule changes will improve continuity of cancer care
23 May 2025 - PHARMAC is proposing a change to the Pharmaceutical Schedule rules, which if agreed, would give New ...
Posted by Michael Wonder on 26 May 2025
Otsuka announces FDA acceptance and priority review of biologics license application for sibeprenlimab in the treatment of immunoglobulin A nephropathy
26 May 2025 - Otsuka Pharmaceutical today announce the US FDA has accepted for review the biologics license application for ...
Posted by Michael Wonder on 25 May 2025
Blenrep (belantamab mafodotin) combinations receive positive CHMP opinion in relapsed/refractory multiple myeloma
23 May 2025 - Positive opinion supported by superior efficacy shown in two head-to-head Phase 3 trials, including overall survival in ...
Posted by Michael Wonder on 25 May 2025
SpringWorks Therapeutics receives positive CHMP opinion for mirdametinib for the treatment of adult and paediatric patients with NF1-PN
23 May 2025 - If approved, mirdametinib is expected to be the first and only therapy in the European Union with ...
Posted by Michael Wonder on 25 May 2025
CHMP recommends EU approval of Roche’s Itovebi for PIK3CA mutated, ER positive, HER2 negative, advanced breast cancer
23 May 2025 - Positive recommendation based on Phase 3 INAVO120 data showing Itovebi (inavolisib) in combination with palbociclib and fulvestrant ...
Posted by Michael Wonder on 25 May 2025
MHRA approves polihexanide to treat acanthamoeba keratitis
23 May 2025 - The Medicines and Healthcare products Regulatory Agency (MHRA) has approved polihexanide (Akantior) to treat acanthamoeba keratitis. ...
Posted by Michael Wonder on 24 May 2025
US FDA approves Liquidia’s Yutrepia (treprostinil) inhalation powder for patients with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease
23 May 2025 - Yutrepia is designed to enhance deep-lung delivery with an easy-to-use device requiring low inspiratory effort. ...