Experts/Officers from the Secretariat of CIB&RC participated for assisting the RC were Dr. Vandana Seth JD (Chem.); Dr. K.L. Gurjar JD (PP);…
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Category:
Regulatory
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2023 ApprovalsMarch 2023NovartisPharma ApprovalsU.S FDA
March 2023 Approval Update – Pharming’s Leniolisib Gains FDA Approval for Treatment for Activated Phosphoinositide 3-Kinase Delta Syndrome
by adminby adminSynopsis:- Joenja is the first drug approved in the U.S. for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in…
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447 RC meetingCIBRC - Indian Pesticide ApprovalsRC Meeting updatesRegulatory
INDIAN APPROVAL – 447TH RC MEETING UPDATES – BAYERS’s SPIROTETRAMAT AND BASF’s AFIDOPYROPEN APPROVALS
by adminby adminSpirotetramat – got the granted for registration of label expansion of Spirotetramat 15.31% OD u/s 9(3) Insecticide Act, 1968 for the control…
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2023 ApprovalsMarch 2023Pharma ApprovalsU.S FDA
March 2023 Approval Update – DAYBUE™ (Trofinetide) from Acadia Pharmaceuticals has Received U.S. FDA Approval for the Treatment of Rett syndrome in Adult and Paediatric patients Two years of age and older.
by adminby adminSynopsis First and only approved therapy for Rett syndrome, a rare, neurodevelopmental disorder, which affects 6,000 to 9,000 patients in the U.S.…
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2023 ApprovalsMay 2023Pharma ApprovalsU.S FDA
May 2023 Approval Update – Astellas’ VEOZAH™ (Fezolinetant) Gets U.S. FDA for Treatment of Vasomotor Symptoms Due to Menopause
by adminby adminOn May 12, the U.S. Food and Drug Administration (FDA) approved VEOZAHTM (Fezolinetant), 45 mg once daily for the treatment of moderate…
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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…