Regulation

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).

Cannabinoid Purification and Scale-Up on Hipersep^® Pilot

For the outstanding efficiency and scalability, high-performance liquid chromatography (HPLC) has been widely used for purification of high-quality APIs and intermediates in the pharmaceutical industry.

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.

Leap Therapeutics announces orphan drug designation of DKN-01 for the treatment of gastric and gastroesophageal junction cancer

Leap Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted the Company orphan drug designation for DKN-01 for the treatment of gastric and gastroesophageal junction cancer.

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).

AlgoTherapeutix announces orphan drug designation granted by fda for atx01 in erythromelalgia

European biotech AlgoTherapeutix, an innovator in complex pain therapy, announces the U.S. Food and Drug Administration (FDA) has granted ATX01 (proprietary topical amitriptyline) Orphan Drug Designation for the treatment of erythromelalgia.