Summary : 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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U.S FDA
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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,…
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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…
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Bristol Myers SquibbRegulatoryU.S FDA
U.S. FDA Approves Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi®(lisocabtagene maraleucel) for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy
by adminby adminSynopsis: In the pivotal Phase 3 TRANSFORM trial, single infusion of Breyanzi significantly outperformed the nearly 30-year standard of care with median…
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CompaniesGlobal MarketMerck & CoRegulatoryU.S FDA
Merck Scores FDA Approval for Vaxneuvance ( Pneumococcal 15-valent conjugate vaccine) for Ages 6 Weeks through 17 Years
by adminby adminSummary : The FDA today approved the pneumococcal 15-valent conjugate vaccine for the prevention of invasive pneumococcal disease in infants and children.…
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AbbVieCompaniesRegulatoryU.S FDA
AbbVie’s Skyrizi (risakizumab-rzaa) Becomes First FDA-Approved IL-23 Inhibitor for Crohn’s Disease
by adminby adminSummary : Third approved indication for SKYRIZI (risankizumab-rzaa) is supported by safety and efficacy data from two induction and one maintenance clinical…
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RegulatoryU.S FDA
FDA Approves First Systemic Treatment Olumiant (Baricitinib) for Alopecia Areata
by adminby adminSummary : The U.S. Food and Drug Administration approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a…
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RegulatorySetmelanotideU.S FDA
Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (Setmelanotide) for Use in Patients with Bardet-Biedl Syndrome
by adminby adminSummary : IMCIVREE now available for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic…