Regulation

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.

EC approves ZYNTEGLO gene therapy for transfusion-dependent β-thalassemia

bluebird bio has secured conditional marketing authorisation from the European Commission (EC) for its one-time gene therapy ZYNTEGLO (autologous CD34+ cells encoding βA-T87Q-globin gene) for the treatment of transfusion-dependent β-thalassemia (TDT).

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.

Vertex to submit VX-445, Tezacaftor and Ivacaftor regimen for global regulatory approvals in cystic fibrosis

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has selected the triple combination of the next-generation corrector VX-445 (elexacaftor), tezacaftor and ivacaftor to submit for potential global regulatory approvals for people ages 12 and older with cystic fibrosis (CF).

Epizyme submits NDA to US FDA for tazemetostat to treat epithelioid sarcoma

Epizyme has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for accelerated approval of tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.