Approvals

FDA approves TEPEZZA for the treatment of thyroid eye disease

Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the U.S. Food and Drug Administration (FDA) has approved TEPEZZA (teprotumumab-trbw) for the treatment of Thyroid Eye Disease (TED).

Jazz Pharmaceuticals receives EU marketing authorisation for Sunosi for excessive daytime sleepiness in adults with narcolepsy or OSA

Jazz Pharmaceuticals announced that the European Commission approved Sunosi (solriamfetol) to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).

AstraZeneca gets FDA orphan drug status for Imfinz plus tremelimumab to treat hepatocellular carcinoma

AstraZeneca has secured orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for Imfinzi (durvalumab) and tremelimumab to treat liver cancer called hepatocellular carcinoma (HCC).

ViiV Healthcare secures Japanese approval for Dovato to treat HIV-1 infection

Specialist HIV company ViiV Healthcare has secured Japanese approval for Dovato (dolutegravir 50mg/lamivudine 300mg) two-drug regimen to treat of HIV-1 infection.

Merck gets FDA nod for Keytruda to treat BCG-unresponsive, high-risk NMIBC

Merck has secured approval from the US Food and Drug Administration (FDA) for its Keytruda to treat patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC).

Ipsen gets UK approval for Dysport to treat upper limb spasticity in children with cerebral palsy

Biopharmaceutical company Ipsen has secured approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its Dysport as a symptomatic treatment for upper limb spasticity in children with cerebral palsy.

AstraZeneca, Merck secure FDA nod for pancreatic cancer drug Lynparza

AstraZeneca and Merck have secured approval from the US Food and Drug Administration (FDA) for Lynparza (olaparib) as a first-line maintenance treatment for germline BRCA-mutated metastatic pancreatic cancer.

Roche’s Kadcyla gets EC nod as adjuvant treatment for HER2-positive early breast cancer

Roche has secured approval from the European Commission (EC) for its Kadcyla (trastuzumab emtansine) as an adjuvant (after surgery) treatment for people with HER2-positive early breast cancer (eBC).

Astellas, Seattle Genetics get FDA’s accelerated approval for bladder cancer drug Padcev

Astellas Pharma and Seattle Genetics have secured accelerated approval from the US Food and Drug Administration (FDA) for Padcev (enfortumab vedotin-ejfv) to treat people with locally advanced or metastatic urothelial cancer.