Summary : 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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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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Bristol Myers SquibbRegulatoryU.S FDA
BMS Scores FDA Approval for Novel HCM Treatment Camzyos (Mavacamten)
by adminby adminSummary : Camzyos (mavacamten), the first FDA-approved cardiac myosin inhibitor that directly addresses the root of obstructive hypertrophic cardiomyopathy, has been authorised…
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Summary : HYFTOR™ is the first topical treatment approved by the FDA for facial angiofibroma in individuals with tuberous sclerosis complex (TSC) 6…
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Summary : The Venus VivaTM will now make its American premiere, having already established itself as a pioneer in the worldwide medical…
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Global MarketRegulatoryU.S FDA
Sol-Gel Technologies and Galderma’s EPSOLAY® Scores US FDA Approval
by adminby adminSummary: EPSOLAY (benzoyl peroxide, cream, 5%) utilizes Sol-Gel’s proprietary microencapsulation technology for the treatment of inflammatory lesions of rosacea and is patent…
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Covid DrugsGileadRegulatoryU.S FDA
Gilead’s Veklury Becomes the First FDA-approved COVID-19 Treatment for Infants
by adminby adminSummary : The first treatment for COVID-19 in young children has been approved by the US Food and Drug Administration. In this…
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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…