Highlights : IFFCO and Mitsubishi Corporation formed a joint venture to produce Tabiki (Flubendiamide 20% WG). The major causes of biotic stress…
Regulatory
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442 RC meetingCIBRC - Indian Pesticide ApprovalsIndiaRC Meeting updates
INDIAN PESTICIDE APPROVALS – 442ND RC MEETING – CHLORANTRANILIPROLE – FMC MOLECULE – MAJOR HIGHLIGHT
by adminby adminINDIAN PESTICIDE APPROVALS UPDATES – MINUTES OF THE 442ND REGISTRATION COMMITTEE (RC) MEETING HELD ON 18.11.2022 The 442nd meeting of the Registration…
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RegulatoryU.S FDA
FDA Approves First-in-Class Microbiota-Based Live Biotherapeutic for C. Difficile Infection
by adminby adminSummary- The FDA has approved fecal microbiota, live-jslm (Rebyota; Ferring Pharmaceuticals) for the prevention of recurring Clostridioides difficile infection (CDI) among patients 18…
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RegulatoryU.S FDA
The FDA has Approved TZIELDTM (Teplizumab-mzwv) as the First and Only Medication Intended to Postpone the onset of Stage 3 Type 1 Diabetes (T1D) in Adult and Paediatric Patients with Stage 2 T1D Who are 8 Years of Age and Older.
by adminby adminSummary:- TZIELD is the first disease-modifying therapy in T1D, a life-threatening autoimmune disease In a clinical trial, in Stage 2 T1D patients,…
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RegulatoryU.S FDA
Libtayo® (cemiplimab-rwlc) in Combination with Chemotherapy Approved by the FDA as First-line Treatment for Advanced Non-small Cell Lung Cancer (NSCLC)
by adminby adminSummary: Approval based on superior survival outcomes of Libtayo plus chemotherapy, compared to chemotherapy alone, in a patient population with a wide…
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CompaniesPfizerRegulatoryU.S FDA
Pfizer’s Elranatamab Granted FDA Breakthrough Therapy Designation for relapsed or Refractory Multiple Myeloma
by adminby adminPfizer Inc. (NYSE:PFE) announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for…
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RegulatoryU.S FDA
U.S. FDA Approves TECVAYLI™ (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
by adminby adminSummary-The Food and Drug Administration granted accelerated approval to teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.), the first bispecific B-cell maturation antigen (BCMA)-directed CD3…
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RegulatoryU.S FDA
Nevro Announces FDA Approval of HFX iQ™ Spinal Cord Stimulation System to Personalize the Treatment of Chronic Pain
by adminby adminNext Generation Senza® HFX iQ™ is the First and Only SCS System that Uses Artificial Intelligence to Optimize and Maintain Pain Relief…
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RegulatoryU.S FDA
Santen and UBE Received FDA Approval for OMLONTI® (Omidenepag Isopropyl Ophthalmic Solution) 0.002% for the Reduction of Elevated Intraocular Pressure in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension
by adminby adminSanten 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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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…