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RSS FeedPosted by Michael Wonder on 14 Dec 2025
Highlights from the 8-11 December 2025 CHMP meeting
12 December 2025 - The EMA’s CHMP recommended seven medicines for approval at its December 2025 meeting. ...
Posted by Michael Wonder on 14 Dec 2025
Milestone receives FDA approval of Cardamyst (etripamil) as first and only self-administered nasal spray for adults with paroxysmal supraventricular tachycardia
12 December 2025 - First FDA approved treatment in 30+ years for more than 2 million Americans with paroxysmal supraventricular tachycardia. ...
Posted by Michael Wonder on 13 Dec 2025
Aflibercept 8 mg recommended for EU approval for third retinal indication
12 December 2025 - Positive opinion of the CHMP is based on the outcomes from the clinical Phase 3 trial QUASAR ...
Posted by Michael Wonder on 13 Dec 2025
More efficacious dose of Wegovy recommended by the EMA can help people with obesity achieve an average of 20.7% weight loss
12 December 2025 - In the STEP UP programme, people with obesity taking Wegovy 7.2 mg lost an average of ...
Posted by Michael Wonder on 13 Dec 2025
Depemokimab receives positive CHMP opinion for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps
12 December 2025 - Positive opinion based on four Phase 3 trials with statistically significant and clinically meaningful primary endpoints across ...
Posted by Michael Wonder on 13 Dec 2025
Nucala (mepolizumab) receives positive CHMP opinion for treatment of chronic obstructive pulmonary disease
12 December 2025 - Positive opinion based on MATINEE Phase 3 trial showing significant reduction in COPD exacerbations versus placebo in ...
Posted by Michael Wonder on 13 Dec 2025
GSK’s RSV vaccine, Arexvy, receives positive CHMP opinion for all adults 18 years and older
12 December 2025 - GSK today announced that the EMA's CHMP has recommended expanding the indication of its adjuvanted recombinant respiratory ...
Posted by Michael Wonder on 13 Dec 2025
Cytokinetics announces positive CHMP opinion of Myqorzo (aficamten) for the treatment of obstructive hypertrophic cardiomyopathy
12 December 2025 - Cytokinetics today announced that the CHMP of the EMA has adopted a positive opinion recommending marketing authorisation ...
Posted by Michael Wonder on 13 Dec 2025
FDA approves two oral therapies to treat gonorrhea
12 February 2025 - Approvals are for uncomplicated urogenital gonorrhea. ...
Posted by Michael Wonder on 13 Dec 2025
BioCryst announces FDA approval of Orladeyo (berotralstat) oral pellets, first and only oral prophylactic treatment for patients with HAE aged 2 to <12 years
12 December 2025 - BioCryst Pharmaceuticals today announced that the US FDA has approved its new drug application for the ...
Posted by Michael Wonder on 12 Dec 2025
FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer
12 December 2025 - Today, the FDA approved niraparib and abiraterone acetate (Akeega, Janssen Biotech) with prednisone for adults with ...
Posted by Michael Wonder on 12 Dec 2025
FDA approves Uplinza for adults with generalised myasthenia gravis
11 December 2025 - Amgen today announced that the US FDA has approved Uplinza (inebilizumab-cdon) for the treatment of generalised myasthenia ...
Posted by Michael Wonder on 12 Dec 2025
PTC Therapeutics announces Health Canada approval of Sephience (sepiapterin) for the treatment of children and adults living with phenylketonuria
10 December 2025 - PTC Therapeutics Canada announced that Health Canada has approved Sephience (sepiapterin) for the treatment of children and ...
Posted by Michael Wonder on 11 Dec 2025
Kymera Therapeutics announces US FDA fast track designation for KT-621, a first in class, oral STAT6 degrader for the treatment of atopic dermatitis
11 December 2025 - Fast track designation supported by positive results from the KT-621 BroADen Phase 1b atopic dermatitis patient trial. ...
Posted by Michael Wonder on 11 Dec 2025
Tris Pharma announces FDA acceptance of NDA for once nightly, low sodium oxybate product for narcolepsy and idiopathic hypersomnia
9 December 2025 - Tris Pharma today announced that the US FDA has accepted the company’s new drug application for TRN-257 ...