On May 12, the U.S. Food and Drug Administration (FDA) approved VEOZAHTM (Fezolinetant), 45 mg once daily for the treatment of moderate…
Regulatory
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2023 ApprovalsMay 2023Pharma ApprovalsU.S FDA
May 2023 Approval Update – Lexicon’s INPEFA™(Sotagliflozin) Notch FDA Approval for Treatment of Heart Failure
by adminby adminSummary:- INPEFA granted broad label across full range of left ventricular ejection fraction, including HFpEF and HFrEF, and for patients with or…
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446 RC meetingCIBRC - Indian Pesticide ApprovalsRC Meeting updates
INDIAN APPROVAL – 446TH RC MEETING UPDATES – CORTEVA GETS FLUAZAINDOLIZINE TECHNICAL AS WELL AS FORMULATION APPROVALS
by adminby adminCorteva got Indian approval of Fluazaindolizine – technical 96.1% w/w min and formulation (41.15% SC) in the 446th Registration Committee (RC) meeting.…
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444 RC MeetingCIBRC - Indian Pesticide ApprovalsRC Meeting updatesRegulatory
INDIAN PESTICIDE APPROVAL UPDATES – MINUTES OF THE 444th REGISTRATION COMMITTEE (RC) MEETING HELD ON 16.01.2023
by adminby adminThe 444th meeting of the Registration Committee (RC) was held under the Chairmanship of Dr. K. Singh, Chairman, Registration Committee on 16.01.2023…
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443RC meetingActive Agrochemical IngredientChlorantraniliproleCIBRC - Indian Pesticide ApprovalsRC Meeting updatesRegulatory
INDIAN PESTICIDE APPROVALS – 443RD RC MEETING – CHLORANTRANILIPROLE – APPROVALS – MAJOR HIGHLIGHT
by adminby adminINDIAN PESTICIDE APPROVALS – 443RD RC MEETING – CHLORANTRANILIPROLE – APPROVALS – MAJOR HIGHLIGHT MINUTES OF THE 443rd REGISTRATION COMMITTEE MEETING HELD…
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RegulatoryU.S FDA
TG Therapeutics Announces FDA Approval of BRIUMVI™ (Ublituximab-xiiy)
by adminby adminSummary:- BRIUMVI is the first and only anti-CD20 monoclonal antibody approved for patients with relapsing forms of multiple sclerosis that can be…
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RegulatoryU.S FDA
FDA Approves Adstiladrin , First Gene Therapy for the Treatment of High-risk, Non-muscle-invasive bladder cancer to Ferring Pharmaceuticals
by adminby adminSummary:- Ferring’s novel adenovirus vector-based gene therapy Adstiladrin® (nadofaragene firadenovec-vncg) is the first gene therapy approved for bladder cancer Efficacy and safety of Adstiladrin supported…
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GileadRegulatoryU.S FDA
Sunlenca® (lenacapavir) Receives FDA Approval as a First-in-Class, Twice-Yearly Treatment Option for People Living With Multi-Drug Resistant HIV
by adminby adminSummary :- Sunlenca is the First and Only Approved Capsid Inhibitor-Based HIV Treatment Option New Drug Application Approval Based on High Rates…
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Mirati TherapeuticsRegulatoryU.S FDA
Mirati Therapeutics Announces U.S. FDA Accelerated Approval of KRAZATI™ (adagrasib) as a Targeted Treatment Option for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation
by adminby adminSummary :-Mirati Therapeutics, Inc. (NASDAQ: MRTX), a targeted oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted…
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IndiaLaunch
Indian Farmers Fertiliser Cooperative Limited and Mitsubishi Corporation Launches Takibi (Flubendiamide 20% WG) Insecticide
by adminby adminHighlights : IFFCO and Mitsubishi Corporation formed a joint venture to produce Tabiki (Flubendiamide 20% WG). The major causes of biotic stress…