Clinical-stage ophthalmology firm Acucela has secured orphan designation from the European Medicines Agency (EMA) for its emixustat hydrochloride to treat Stargardt disease.
Reata Pharmaceuticals, a clinical-stage biopharmaceutical company, announced the US Food and Drug Administration (FDA) has granted orphan drug designation to bardoxolone methyl (bardoxolone) for the treatment of autosomal dominant polycystic kidney disease (ADPKD).
Eli Lilly has secured approval from the US Food and Drug Administration (FDA) for its Emgality (galcanezumab-gnlm) injection (300mg) to treat episodic cluster headache in adults.
The U.S. Food and Drug Administration today approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older.
German neurotoxin firm Merz has secured European approval for its Xeomin (incobotulinumtoxinA) for the symptomatic treatment of chronic sialorrhea (drooling) due to neurological disorders in adult patients.
Celgene has secured approval from the US Food and Drug Administration (FDA) for its Revlimid (lenalidomide) in combination with a rituximab product (R²) to treat adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL).
Novartis has secured approval from the US Food and Drug Administration (FDA) for its breast cancer drug combo Piqray (alpelisib, formerly BYL719) plus fulvestrant.
The US Food and Drug Administration today approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), the most severe form of SMA and a leading genetic cause of infant mortality.
GlaxoSmithKline (GSK) has secured approval from China’s National Medical Products Administration (NMPA) for Shingrix vaccine to prevent shingles (herpes zoster) in adults aged 50 years or older.
Mayne Pharma Group has announced that the US Food and Drug Administration (FDA) has approved SORILUX (calcipotriene) Foam, 0.005% in adolescents.
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