Synopsis: 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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AdamaBrazilCombination ProductsGlobal MarketLaunch
ADAMA Launches Combination Herbicide Apresa (flumioxazine + S-metolachlor) in Brazil
by adminby adminSummary : Apresa, a premium pre-emergent herbicide for various crops with an exclusive combination of active chemicals (Flumioxazin + S-metolachlor), was introduced…
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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…
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RegulatoryU.S FDA
Alnylam Scores Another FDA Nod for Amvuttra (Vutrisiran) for the Treatment of Hereditary Transthyretin-Mediated Amyloidosis (hATTR)
by adminby adminSummary : Amvuttra (vutrisiran) from Alnylam Pharmaceuticals has been licenced by the US Food and Drug Administration for the treatment of hereditary…
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RegulatoryRocheU.S FDA
FDA Approves Roche’s Evrysdi for Use in Babies under Two Months with Spinal Muscular Atrophy (SMA)
by adminby adminSummary : Roche announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include…
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Amgen Inc.RegulatoryU.S FDA
FDA Approves RIABNI™ (Rituximab-arrx), a Biosimilar to Rituxan® (Rituximab), for adults with moderate to severe Rheumatoid Arthritis
by adminby adminSummary : Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved RIABNI™ (rituximab-arrx), a biosimilar to Rituxan®, in…
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Global MarketRegulatorySanofi Inc.U.S FDA
FDA Approves Dupixent®(Dupilumab) as First Biologic Medicine for Children Aged 6 Months to 5 Years with Moderate-to-Severe Atopic Dermatitis
by adminby adminSummary : Children treated with Dupixent and topical corticosteroids (TCS) achieved clearer skin, experienced significantly improved overall disease severity and significantly reduced…