Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (Santen), and UBE Corporation (UBE) today announced that the U.S. Food and…
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U.S. Food and Drug Administration (FDA)
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RegulatoryU.S FDA
Incyte Announces FDA Approval of Pemazyre® (Pemigatinib) as the First and Only Targeted Treatment for Myeloid/Lymphoid Neoplasms (MLNs) with FGFR1 Rearrangement
by adminby adminSynopsis : This marks the second indication for Pemazyre, which received accelerated FDA approval in 2020 for adults with previously treated, unresectable…
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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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CompaniesMerger / AcquisitionPfizer
Pfizer Acquire ReViral for $ 525 Millon and its Respiratory Syncytial Virus Therapeutic Candidates Sisunatovir
by adminby adminSynopsis : Under the terms of the agreement, Pfizer will acquire ReViral for a total consideration of up to $525 million, including…
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Agrochemicals
Gilead : U.S. FDA Approves Kite’s Tecartus® as the First and Only Car T for Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
by adminby admin— 65% of Patients Achieved Overall Complete Remission with Tecartus — — High Unmet Need: Fifty Percent of Adult Patients Will Relapse…