Approvals

Epizyme announces US FDA accelerated approval of TAZVERIK for relapsed/refractory follicular lymphoma

Epizyme, a fully integrated, commercial-stage biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for TAZVERIK™ (tazemetostat) for the following two distinct follicular lymphoma (FL) indications.

Novartis gets FDA approval for Cosentyx to treat active non-radiographic axial spondyloarthritis

Novartis has secured approval from the US Food and Drug Administration (FDA) for its Cosentyx (secukinumab) to treat active non-radiographic axial spondyloarthritis (nr-axSpA).

Jazz, PharmaMar get FDA accelerated approval for Zepzelca in metastatic SCLC

Jazz Pharmaceuticals and PharmaMar have secured accelerated approval from the US Food and Drug Administration (FDA) for Zepzelca (lurbinectedin) for the treatment of metastatic small cell lung cancer (SCLC).

NeoImmuneTech receives FDA orphan drug designation for NT-I7 to treat Progressive Multifocal Leukoencephalopathy

NeoImmuneTech, a clinical-stage T cell-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NeoImmuneTech’s NT-I7 (efineptakin alfa), the only clinical-stage long-acting human IL-7, for the treatment of Progressive Multifocal Leukoencephalopathy (PML).

FDA approves dispersible tablet formulation of dolutegravir for HIV in children

ViiV Healthcare has been granted approval by the US Food and Drug Administration (FDA) for Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for suspension for the treatment of human immunodeficiency virus type 1 (HIV-1) in infants and children.

Vertex gets EC nod for Kalydeco to treat children and adolescents with cystic fibrosis

Vertex Pharmaceuticals has secured approval from the European Commission (EC) for its Kalydeco (ivacaftor) to treat children and adolescents with cystic fibrosis (CF).

Merck secures FDA approval for Recarbrio to treat adults with HABP/VABP

Merck has secured approval from the US Food and Drug Administration (FDA) for its Recarbrio (imipenem, cilastatin, and relebactam) to treat adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).

Pierre Fabre gets EC nod for Braftovi plus cetuximab to treat BRAFV600E-mutant mCRC

Pierre Fabre has secured approval from the European Commission (EC) for Braftovi (encorafenib) plus cetuximab (Erbitux) to treat adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) who have received prior systemic therapy.

FDA approves new indication for AstraZeneca’s heart disease drug Brilinta

AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its Brilinta (ticagrelor) to minimise the risk of a first heart attack or stroke in high-risk patients with a heart disease known as coronary artery disease (CAD).