Summary: Australia has authorised the use of a new targeted therapy for the treatment of cholangiocarcinoma, a rare bile duct cancer. The…
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Active Agrochemical IngredientChlorantraniliprolePatent Litigation
Chlorantraniliprole Patent Litigation Outcome – Best Agrolife Ltd. & Natco to become First Indian Companies to launch Indigenously Manufactured Chlorantraniliprole (CTPR)
by adminby adminBest Agrolife Ltd. & Natco to become the First Indian Company to launch Indigenously Manufactured Best Agrolife Ltd Chlorantraniliprole CTPR technology is…
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GskWHO
WHO Grants Prequalification to GSK’s Mosquirix – the first and only approved Malaria Vaccine
by adminby adminSummary: The World Health Organization (WHO) has awarded prequalification to Mosquirix, GSK’s malaria vaccine. This is the first prequalification for a malaria vaccine…
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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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Synopsis: On September 1, 2022, Novo Nordisk and Forma Therapeutics revealed that Novo Nordisk would buy Forma Therapeutics for for $1.1 billion.…
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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…
