Summary : Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States Food and Drug Administration (FDA) has…
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U.S FDA
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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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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…
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RegulatorySanofi Inc.U.S FDA
Nexviazyme® improves respiration and mobility long-term in Pompe disease patients
by adminby adminSummary : Two-year data shows Pompe disease patients treated with Nexviazyme® (avalglucosidase alfa) have sustained improvements in respiratory function and mobility. Sanofi has…
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CompaniesCovid DrugsModernaPfizerRegulatoryU.S FDA
Moderna and Pfizer are Well-Positioned to Take mRNA into the Future
by adminby adminSummary : It’s an understatement to note that the bottom lines for Moderna and Pfizer have been fattened by the success of…
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Covid DrugsRegulatoryU.S FDA
Ocugen Ends Week on Low as FDA Rejects Covaxin EUA for Kids
by adminby adminSummary : The U.S. Food and Drug Administration turned down Ocugen’s Emergency Use Authorization (EUA) request for Covaxin in children 2 to…