Approvals

Roche gets Chinese approval for Tecentriq plus chemotherapy to treat ES-SCLC

Roche has secured approval from the China National Medical Products Administration (NMPA) for Tecentriq (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) as a first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC).

ReAlta Life Sciences announces FDA orphan drug designation for PIC1 to treat hypoxic-ischemic encephalopathy

ReAlta Life Sciences announced that US Food and Drug Administration (FDA) has granted orphan drug designation to PIC1-dPEG24 for the treatment of hypoxic-ischemic encephalopathy (HIE) in neonates.

Aimmune’s Palforzia gets FDA approval for treatment of peanut allergy

Aimmune Therapeutics has secured approval for Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] from the US Food and Drug Administration (FDA) to treat patients with peanut allergy.

FDA approves Merck’s DIFICID to treat Clostridioides difficile in children aged six months and older

Merck, known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for DIFICID® (fidaxomicin) for oral suspension, and a supplemental New Drug Application (sNDA) for DIFICID tablets for the treatment of Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) in children aged six months and older.

Epizyme gets FDA approval for Tazverik to treat epithelioid sarcoma

Epizyme has secured accelerated approval from the US Food and Drug Administration (FDA) for its Tazverik (tazemetostat) to treat pateints epithelioid sarcoma.

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.