Daiichi Sankyo’s VANFLYTA® Approved for Acute Myeloid Leukaemia in EU
VANFLYTA® (quizartinib) is now the first FLT3 inhibitor approved in the European Union (EU) specifically for the treatment of patients
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Regulatory
Sandoz Receives EC Approval for First Biosimilar for MS
The Biosimilar Tyruko® has been approved for all indications of reference medicine, as the first and only biosimilar to treat
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Pfizer and BioNTech Granted Favorable CHMP Assessment for Omicron XBB.1.5-adapted COVID-19 Vaccine in the EU
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommendation is grounded in pre-clinical
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FDA Greenlights First-ever Treatment for Demodex Blepharitis
Tarsus Pharmaceuticals, Inc. has received FDA approval for XDEMVY™ (lotilaner ophthalmic solution) 0.25% as a therapeutic solution for Demodex blepharitis,
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FDA Approves Krystal Biotech’s VYJUVEK™: First Redosable Skin-disorder Gene Therapy
Krystal Biotech, Inc., a Pennsylvania-headquartered biotech company specialising in genetic medicines for rare diseases, announced on Friday that the US
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Astellas Pharma’s Pill for Menopause Hot Flashes Approved by the US FDA
Astellas Pharma Inc announced that the US Food and Drug Administration (FDA) has given approval for the oral drug VEOZAHTM
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Chiesi and Protalix’s Therapy for Fabry Disease Receives Marketing Approval from EC
Chiesi Global Rare Diseases and Protalix BioTherapeutics, Inc. have received marketing authorization from the European Commission (EC) for their drug,
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Janssen Claims First Global Approval for AKEEGA®
Janssen has received its first worldwide approval for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) as EC Authorized treatment
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FDA Grants Fast Track Designation for Shionogi’s Investigational COVID-19 Oral Antiviral
Japanese multinational pharmaceutical company Shionogi & Co., Ltd,. announced at the beginning of April that the U.S. FDA has granted
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FDA Grants EUA for InflaRx’s Gohibic (vilobelimab) to Treat Critically Ill COVID-19 Patients
InflaRx N.V., a biopharmaceutical company in the clinical stage of developing anti-inflammatory therapeutics that target the complement system, has announced
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