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Approvals for Endo, Boehringer Ingelheim; designations for Novartis, J&J

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Approvals for Endo, Boehringer Ingelheim; designations for Novartis, J&J

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Sept. 6.

Approvals

* Endo International PLC's first generic version of Swedish Orphan Biovitrum AB (publ)'s medicine Orfadin for hereditary tyrosinemia type 1.

* Boehringer Ingelheim Corp.'s Ofev as the first treatment for systemic sclerosis.

* Oventus Medical Ltd.'s oral device O2Vent Optima for obstructive sleep apnea.

SNL ImageFDA headquarters in Silver Spring, Md.
Source: Associated Press

Fast track

* Forty Seven Inc.'s magrolimab for myelodysplastic syndrome and acute myeloid leukemia.

Breakthrough therapy

* Novartis AG's oral drug capmatinib as initial treatment for metastatic non-small cell lung cancer with the MET exon-14 skipping genetic mutation.

* Johnson & Johnson's investigational vaccine for preventing respiratory syncytial virus.

Other designations

* Orphan drug, for Puma Biotechnology Inc.'s Nerlynx for breast cancer that has spread to the brain.

* Orphan drug, for BioXcel Therapeutics Inc.'s BXCL701 for acute myeloid leukemia.

* Orphan drug, for GeneTx Biotherapeutics LLC and Ultragenyx Pharmaceutical Inc.'s GTX-102 for Angelman syndrome.

* Orphan drug, for Ra Pharmaceuticals Inc.'s zilucoplan for myasthenia gravis.

* Rare pediatric disease, for GeneTx Biotherapeutics and Ultragenyx Pharmaceutical's GTX-102 for Angelman syndrome.

* Regenerative medicine advanced therapy, for Magenta Therapeutics Inc.'s experimental one-time cell therapy MGTA-456 for Hurler syndrome, cerebral adrenoleukodystrophy, metachromatic leukodystrophy or globoid cell leukodystrophy.