The 451st meeting of the Registration Committee (RC) was held under the Chairmanship of Dr. P. K. Singh, Chairman, Registration Committee on…
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450 RC meetingAgrochemicalsRC Meeting updates
SEPTEMBER 2023 – INDIAN PESTICIDE APPROVAL UPDATE || MINUTES OF THE 450TH REGISTRATION MEETING GET PUBLISHED
by adminby adminAgrochemical / bio-pesticide solo and various combination (mixture) case were discussed, wherein major highlights are as follows M/s Sumitomo Chemical India Ltd.,…
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2023 ApprovalsBiogenU.S FDA
August 2023 Approval Update: Sage and Biogen’s Zurzuvae™ (Zuranolone) notched FDA approval for the Treatment of Women with Postpartum Depression
by adminby adminThe U.S. Food and Drug Administration (FDA) on Friday approved Biogen and Sage Therapeutics oral pill to treat postpartum depression (PPD) in…
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449 RC meetingAgrochemicalsRC Meeting updates
INDIAN PESTICIDE APPROVAL UPDATE || MINUTES OF THE 449TH REGISTRATION MEETING GET PUBLISHED
by adminby adminAgrochemical solo and various combination (mixture) case were discussed, wherein major highlights are as follows Syngenta India Ltd., got approval for import…
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448 RC meetingAgrochemicals
INDIAN PESTICIDE APPROVAL UPDATE || MINUTES OF THE 448TH REGISTRATION MEETING GET PUBLISHED
by adminby adminExperts/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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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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