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RSS FeedPosted by Michael Wonder on 18 Jul 2025
Aldeyra Therapeutics announces FDA acceptance for review of reproxalap new drug application for the treatment of dry eye disease
17 July 2025 - PDUFA target action date 16 December 2025. ...
Posted by Michael Wonder on 18 Jul 2025
Johnson & Johnson receives US FDA priority review for TAR-200 NDA in high-risk non-muscle invasive bladder cancer
17 July 2025 - New drug application supported by results from the Phase 2b SunRISe-1 study. ...
Posted by Michael Wonder on 18 Jul 2025
Praxis Precision Medicines receives FDA breakthrough therapy designation for relutrigine for the treatment of seizures associated with SCN2A and SCN8A developmental and epileptic encephalopathies
17July 2025 - The breakthrough therapy designation was granted based on the highly compelling results from the Phase 2 EMBOLD trial ...
Posted by Michael Wonder on 18 Jul 2025
ICER publishes evidence report on treatments for spinal muscular atrophy
17 July 2025 - There are many remaining uncertainties around the best management of spinal muscular atrophy; ICER estimates that ...
Posted by Michael Wonder on 17 Jul 2025
Enhertu plus pertuzumab granted breakthrough therapy designation in the US as first-line therapy for patients with HER2 positive metastatic breast cancer
17 July 2025 - Ninth breakthrough therapy designation for Daiichi Sankyo and AstraZeneca’s Enhertu with the latest based on DESTINY-Breast09 ...
Posted by Michael Wonder on 17 Jul 2025
Thousands more breast cancer patients to benefit from new NHS treatment
17 July 2025 - NICE approves ribociclib combination therapy to help prevent cancer returning in early stage disease. ...
Posted by Michael Wonder on 17 Jul 2025
Eli Lilly calls out Korea as Verzenio’s $36K cost threatens cure window
17 July 2025 - While Eli Lilly’s Verzenio (abemaciclib) continues to rack up global sales on the strength of its ...
Posted by Michael Wonder on 17 Jul 2025
Pfizer broadside on PBS productivity amid pharma tariff fears
16 July 2025 - Multinational conglomerate Pfizer has accused the PBS of “undervaluing” medical products in a submission to the ...
Posted by Michael Wonder on 17 Jul 2025
Labor and Coalition in lockstep as Trump threatens to pull pharma tariffs forward
16 July 2025 - US President Donald Trump’s threat to bring forward planned tariffs of up to 200% on pharmaceuticals ...
Posted by Michael Wonder on 16 Jul 2025
Sanofi’s SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration
16 July 2025 - The US FDA has granted fast track designation to SAR446597, a one-time intravitreal gene therapy for ...
Posted by Michael Wonder on 16 Jul 2025
SMC - July 2025 decisions
7 July 2025 - The SMC which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 16 Jul 2025
MHRA approves sebetralstat (Ekterly) to treat hereditary angioedema attacks in patients aged 12 and over
15 July 2025 - The MHRA has today approved sebetralstat (Ekterly) for the treatment of hereditary angioedema attacks in adults and ...
Posted by Michael Wonder on 16 Jul 2025
FDA embraces radical transparency by publishing complete response letters
10 July 2025 - The US FDA today published more than 200 decision letters, known as complete response letters. ...
Posted by Michael Wonder on 16 Jul 2025
BeOne bets Tevimbra will beat rivals to PD-1 reimbursement in Korea
15 July 2025 - BeOne Medicines (formerly BeiGene) is doubling down on Korea’s immunotherapy market with an early access push ...
Posted by Michael Wonder on 16 Jul 2025
Corcept submits new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer
14 July 2025 - Corcept Therapeutics has submitted a new drug application to the US FDA for its proprietary, selective ...