Approvals

FDA approves Amgen and Allergan’s trastuzumab biosimilar Kanjinti

Amgen and Allergan have secured approval from the US Food and Drug Administration (FDA) for Kanjinti (trastuzumab-anns), a biosimilar to Roche’s Herceptin (trastuzumab).

FDA extends approval of Merck’s Keytruda in head and neck cancer

Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) has been approved by the US Food and Drug Administration (FDA) for two more indications in head and neck cancer.

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).