Summary: The FDA has approved Axsome Therapeutics’ Auvelity for major depressive disorder (MDD) in adults, making it the first and only oral…
ChemRobotics Pvt. Ltd. © 2023, All Rights Reserved.
Designed and Developed by Ample eBusiness
Category:
Regulatory
-
-
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…
-
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…
-
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…
-
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 …
-
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…
-
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…
-
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…
-
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,…
-
Global MarketRegulatoryU.S FDA
Beyond Air’s LungFit® PH Receives FDA Approval to Treat Term and Near-Term Neonates with Hypoxic Respiratory Failure
by adminby adminSummary : First and only nitric oxide generator and delivery system indicated for the treatment of termand near-term neonates with hypoxic respiratory…