Approvals

Bayer gets FDA approval for prostate cancer drug Nubeqa

Bayer has secured approval from the US Food and Drug Administration (FDA) for its Nubeqa (darolutamide) to treat patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

Pfizer gets FDA nod for biosimilar to Roche’s cancer drug Rituxan

Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Ruxience (rituximab-pvvr), a biosimilar to Roche’s cancer drug Rituxan (rituximab), to treat certain cancers and autoimmune conditions.

FDA approves Baxter’s IV insulin Myxredlin

Baxter International has secured approval from the US Food and Drug Administration (FDA) for its Myxredlin (insulin human in 0.9% sodium chloride injection).

Novartis multiple sclerosis product Gilenya approved in China

The Chinese National Medical Products Administration (NMPA) approved Gilenya for relapsing forms of multiple sclerosis (RMS) for adults and children 10 years and older.

Celgene gets FDA approval for Otezla to treat oral ulcers associated with Behçet’s Disease

Celgene has secured approval from the US Food and Drug Administration (FDA) for its Otezla (apremilast) 30mg twice daily (BID) to treat adult patients with oral ulcers associated with Behçet’s Disease.

LifeMax receives rare pediatric disease designation for LM-030 to treat Netherton Syndrome

LifeMax Laboratories, a private company focused on treating rare diseases with few or no therapeutic options, announced that the Food & Drug Administration (FDA) granted rare pediatric disease designation to LM-030, an investigational therapy licensed from Novartis and ready to enter into pivotal clinical trials for the treatment of Netherton Syndrome.

FDA approves Merck’s Recarbrio to treat complicated infections

Merck has secured approval from the US Food and Drug Administration (FDA) for its Recarbrio (imipenem, cilastatin and relebactam) to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

Dicerna gets breakthrough therapy designation for DCR-PHXC to treat primary hyperoxaluria type 1

Dicerna Pharmaceuticals announced that the US Food and Drug Administration (FDA) has granted a breakthrough Therapy Designation (BTD) to DCR-PHXC for the treatment of patients with primary hyperoxaluria type 1 (PH1).

Sensorion receives FDA IND approval for Arazasetron

Sensorion has received the investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with SENS-401, based on preclinical data and clinical development plan.