Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (Santen), and UBE Corporation (UBE) today announced that the U.S. Food and…
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Regulatory
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RegulatoryU.S FDA
bluebird bio Receives FDA Accelerated Approval for SKYSONA®(elivaldogene autotemcel)Gene Therapy for Early, Active Cerebral Adrenoleukodystrophy (CALD)
by adminby adminSynopsis: SKYSONA is the first FDA approved therapy shown to slow the progression of neurologic dysfunction in boys with this devastating and…
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RegulatoryU.S FDA
Mallinckrodt Receives U.S. FDA Approval for Terlivaz® (Terlipressin) for Injection for the Treatment of Hepatorenal Syndrome (HRS)
by adminby adminHighlights: Terlivaz is the first and only FDA-approved treatment for adults with HRS involving rapid reduction in kidney function. Terlivaz is expected…
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RegulatoryU.S FDA
Spectrum Pharmaceuticals Receives FDA Approval for ROLVEDON™ (eflapegrastim-xnst) Injection
by adminby adminSummary: First novel Long-Acting GCSF (LA-GCSF) product approved in over 20 years ROLVEDON™ developed using proprietary LAPSCOVERY™ technology with a differentiated molecular structure and…
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Bristol Myers SquibbRegulatoryU.S FDA
Bristol Myers Squibb Notches another FDA Approval for Sotyktu™ (Deucravacitinib), Oral Treatment for Adults with Moderate-to-Severe Plaque Psoriasis
by adminby adminHighlights: Bristol Myers Squibb’s Sotyktu, a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is the only approved TYK2 inhibitor worldwide and the…
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RegulatoryU.S FDA
QOL Medical, LLC receives FDA approval of Sucraid® (Sacrosidase) Oral Solution single-use containers for Patients with Congenital Sucrase-Isomaltase Deficiency (CSID)
by adminby adminQOL Medical, LLC, a ground-breaking, rare disease pharmaceutical company, announced today that the United States (U.S.) Food & Drug Administration (FDA) approved Sucraid® single-use containers…
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RegulatoryU.S FDAVertex
Vertex Announces U.S. FDA Approval for ORKAMBI® (lumacaftor/ivacaftor) in Children With Cystic Fibrosis Ages 12 to 24 months
by adminby adminSummary: Orkambi was first approved in 2015 in the US and is now available in more than 30 countries. Vertex Pharmaceuticals Incorporated…
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Boehringer IngelheimRegulatoryU.S FDA
Boehringer’s Spevigo (spesolimab) Bags First FDA Approval for Rare Skin Disease, for Generalized Pustular Psoriasis (GPP)
by adminby adminSynopsis: German drugmaker Boehringer Ingelheim has its first regulatory approval for spesolimab, its antibody therapy for rare and life-threatening skin disorder generalised…
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RegulatorySanofi Inc.U.S FDA
XenpozymeTM (Olipudase alfa-rpcp) Approved by FDA as First Disease-Specific Treatment for Acid Sphingomyelinase Deficiency, a Rare Genetic Disease to Sanofi
by adminby adminSummary: XenpozymeTM (olipudase alfa-rpcp) approved by FDA as first disease-specific treatment for ASMD (non-CNS manifestations) Xenpozyme is the first approved medication to treat symptoms that are not related…
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RegulatoryU.S FDA
Incyte Announces FDA Approval of Pemazyre® (Pemigatinib) as the First and Only Targeted Treatment for Myeloid/Lymphoid Neoplasms (MLNs) with FGFR1 Rearrangement
by adminby adminSynopsis : This marks the second indication for Pemazyre, which received accelerated FDA approval in 2020 for adults with previously treated, unresectable…