Future Medicine India – Drug Approvals Drug Approvals Archives | Future Medicine India

Drug Approvals

Mobocertinib gets breakthrough therapy status to treat NSCLC

Takeda Pharmaceutical said the US FDA granted Breakthrough Therapy Designation for its investigational drug mobocertinib (TAK-788) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

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Quadrivalent vaccine to prevent meningococcal disease

The US FDA has approved a Biologics License Application for MenQuadfi Meningococcal (Groups A, C, Y, W) conjugate vaccine for the prevention of invasive meningococcal disease in persons 2 years of age and older.

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Nintedanib to treat interstitial lung disease in Europe

Boehringer Ingelheim said the European Commission (EC) has approved nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adults.

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Pemigatinib to treat cholangio carcinoma

The US FDA has approved pemigatinib (Pemazyre), a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

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Orphan drug status to PBGM01 for treating GM1 gangliosidosis

The US FDA has granted Orphan Drug Designation to its lead product candidate, PBGM01, for the treatment of infantile GM1 gangliosidosis (GM1).

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New aflibercept injection pre-filled syringe in EU

The European Medicines Agency (EMA) has granted approval for the new aflibercept (Eylea) injection pre-filled syringe.

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Selumetinib for paediatric patients with NF1 PN

AstraZeneca and MSD announced that the US FDA has approved selumetinib (Koselugo) for the treatment of paediatric patients two years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).

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