Synopsis : This marks the second indication for Pemazyre, which received accelerated FDA approval in 2020 for adults with previously treated, unresectable…
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Regulatory
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RegulatoryU.S FDA
Axsome Therapeutics Auvelity(dextromethorphan HBr -bupropion HCl) Becomes the First FDA-Approved Oral NMDA for Major Depression
by adminby adminSummary: The FDA has approved Axsome Therapeutics’ Auvelity for major depressive disorder (MDD) in adults, making it the first and only oral…
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Global MarketRegulatoryU.S FDA
Genentech Announces FDA Approval of Xofluza(Baloxavir Marboxil) to Treat Influenza in Children Aged Five and Older
by adminby adminSummary: Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved for children as young…
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AstraZenecaRegulatoryU.S FDA
ENHERTU® Approved in the U.S. as the First HER2 Directed Therapy for Patients with HER2 Low Metastatic Breast Cancer
by adminby adminSynopsis: Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and…
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Marius PharmaceuticalsRegulatoryU.S FDA
Marius Pharmaceuticals Receives FDA Approval of KYZATREX™, an Oral Testosterone Replacement Therapy
by adminby adminSummary : Marius Pharmaceuticals, a patient-centric healthcare company, today announced the approval of KYZATREX™ (testosterone undecanoate) by the U.S. Food and Drug…
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Pharma Science & ResearchRegulatoryU.S FDA
FDA Grants Coherus’ CIMERLITM (Ranibizumab-eqrn) 12 Months of Interchangeability Exclusivity as the First and Only Interchangeable Biosimilar to Lucentis® for all Five Indications.
by adminby adminSynopsis : CIMERLI™ is Coherus’ third FDA-approved product and the first of four new product launches planned by the end of 2023 …
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RegulatoryU.S FDA
FDA Approved ZONISADE™ (Zonisamide Oral Suspension) of AZURITY PHARMACEUTICALS, INC.
by adminby adminSummary : The first and only FDA-approved zonisamide oral liquid formulation 100 mg/5 mL as adjunctive therapy for the treatment of partial…
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RegulatoryU.S FDA
The U.S. FDA has Approved Opzelura(Ruxolitinib) Cream by Incyte for the Treatment of Vitiligo.
by adminby adminSynopsis : Opzelura is the first and only FDA-approved product for repigmentation in nonsegmental vitiligo Phase 3 data supporting the approval show…
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Global MarketRegulatoryU.S FDA
Elite Pharmaceuticals Receives FDA Approval for Generic Sabril(R)
by adminby adminSummary : Elite Pharmaceuticals, Inc. (“Elite” or the “Company”) (OTCQB:ELTP), a specialty pharmaceutical company developing niche generic products, today announced that it…
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RegulatoryU.S FDA
The FDA Designated PT886 from Phanes Therapeutics as an Orphan Drug for the Treatment of Pancreatic Cancer.
by adminby adminSynopsis : The U.S. Food and Medication Administration (FDA) has designated PT886 as an orphan drug for the treatment of pancreatic cancer,…