Approvals

Genentech secures FDA accelerated approval for Polivy, BR combo for DLBCL

Roche’s subsidiary Genentech has secured accelerated approval from the US Food and Drug Administration (FDA) for Polivy (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan (rituximab) (BR) for the treatment of diffuse large B-cell lymphoma (DLBCL).

Acucela gets European orphan designation for emixustat to treat Stargardt disease

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 gets orphan drug designation for bardoxolone methyl to treat ADPKD

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 gets FDA nod for Emgality to treat episodic cluster headache

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.

FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia

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.

Merz gets European approval for Xeomin to treat chronic sialorrhea in adults

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 gets FDA nod for blood cancer drug combo Revlimid plus rituximab

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 gets FDA nod for breast cancer drug combo Piqray plus fulvestrant

Novartis has secured approval from the US Food and Drug Administration (FDA) for its breast cancer drug combo Piqray (alpelisib, formerly BYL719) plus fulvestrant.

FDA approves gene therapy to treat pediatric patients with spinal muscular atrophy

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.