MINUTES OF THE 437th REGISTRATION COMMITTEE (RC) MEETING HELD ON 16.03.2022. The 437th meeting of the Registration Committee (RC) was held under…
Regulatory
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AscenzaLaunch
In Brazil, Ascenza’s multisite fungicide has been licenced for minor crops.
by adminby adminSummary : Cuprital 700, a protective multisite fungicide/bactericide, has been approved for use in fruits and vegetables, as well as large crops,…
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RegulatoryU.S FDA
Telix Granted FDA Orphan Drug Designation for Bone Marrow Conditioning Treatment
by adminby adminSummary : Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States Food and Drug Administration (FDA) has…
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RegulatoryU.S FDA
CANbridge Pharmaceuticals CAN108 New Drug Application/Orphan Drug Registration (NDA/ORD) for Alagille Syndrome Accepted by the Taiwan Food and Drug Administration
by adminby adminSummary Taiwan Food and Drug Administration (TFDA) has accepted the New Drug Application/Orphan Drug Registration (NDA/ODR) for CAN108 (maralixibat oral solution (LIVMARLI TM))…
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RegulatoryU.S FDA
IQVIA selected to accelerate clinical development of VYVGART by argenx SE
by adminby adminSynopsis : IQVIA announced an agreement today with argenx SE. The multi-year contract covers a unique collaboration for the development of new…
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Agro Science & ResearchLaunch
In Brazil, Corteva Agriscience has released a new generation of fungicides for small crops.
by adminby adminSummary : Corteva Agriscience has announced the debut of “Range Z,” a new generation of fungicides for minor crops based on a…
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RegulatoryU.S FDA
FDA approves first generic of Symbicort to treat asthma and COPD
by adminby adminSummary : Today, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol…
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AstraZenecaCompaniesMerck & CoRegulatoryU.S FDA
AZ, Merck get FDA okay for Lynparza as adjuvant breast cancer therapy
by adminby adminSummary : The FDA has cleared AstraZeneca and Merck & Co’s Lynparza as an adjuvant or neoadjuvant treatment for breast cancer, extending…
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AstraZenecaRegulatoryU.S FDA
FDA says no to AZ’s Fasenra for nasal polyp indication
by adminby adminSummary : AstraZeneca has failed in its bid to get US approval for its IL-5 inhibitor Fasenra as a treatment for chronic…
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Alembic PharmaRegulatoryU.S FDA
Alembic Pharmaceuticals bags USFDA nod for Macitentan tablets
by adminby adminSummary : Alembic Pharmaceuticals received a tentative approval from the United States Food & Drug Administration (USFDA) for its Abbreviated New Drug…
