SunGen Pharma, a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products, today announced it has received its seventh ANDA approval from the US Food and Drug Administration (FDA).
Endo International announced that Novitium Pharma, a partner of its subsidiary Endo Ventures, received approval from the US Food and Drug Administration for a room temperature stable, AB-rated, generic equivalent of Swedish Orphan Biovitrum's Orfadin (nitisinone capsules).
Allergan has received U.S. Food and Drug Administration (FDA) approval for the use of Juvéderm VOLUMA XC, a hyaluronic acid gel dermal filler, with a TSK STERiGLIDE cannula for cheek augmentation to correct age-related volume deficit in the mid-face in adults over 21.
SpringWorks Therapeutics, Inc. a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for nirogacestat, an oral, selective, small molecule, gamma-secretase inhibitor, for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.
Roche has secured approval from the European Commission (EC) for its Tecentriq (atezolizumab) in combination with Abraxane to treat people with PD-L1-positive and metastatic triple-negative breast cancer (TNBC).
The U.S. Food and Drug Administration today approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing "off" episodes.
Eli Lilly and Company (Lilly) has secured approval for its monoclonal antibody Taltz (ixekizumab) from the US Food and Drug Administration (FDA) for the treatment of active ankylosing spondylitis (AS) in adults.
GlaxoSmithKline’s (GSK) immuno-conjugate belantamab mafodotin (GSK2857916) has achieved its primary objective in the multiple myeloma trial.
Moderna, a biotechnology company, has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational Zika vaccine, mRNA-1893.
AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR).
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