Cosette Pharmaceuticals has secured a significant regulatory milestone with the United States Food and Drug Administration (FDA) granting approval for…
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FDA Approves Zanvastro as the First Disease-Modifying Treatment for Rare Alexander Disease
The U.S. Food and Drug Administration (FDA) has officially granted approval to Zanvastro, marking a watershed moment in medical history…
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FDA Approves Asahi Kasei Therapeutics Hovilpri for Refractory Mucocutaneous Herpes Simplex Virus in Immunocompromised Adults
The United States Food and Drug Administration (FDA) has granted formal marketing approval for Hovilpri (pritelivir) 100mg tablets, developed by…
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FDA Approves Pfizer’s Tukysa Regimen as Frontline Maintenance Therapy for Advanced HER2-Positive Breast Cancer
The United States Food and Drug Administration (FDA) has granted regulatory approval to Pfizer’s targeted oncology medication Tukysa (tucatinib) in…
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FDA approves expanded indication for Lilly’s Jaypirca
The United States Food and Drug Administration (FDA) has granted an expanded regulatory approval for Eli Lilly and Company’s Jaypirca,…
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FDA Approves Eli Lilly’s Once-Weekly Basal Insulin Onswik for Type 2 Diabetes Following Robust Phase III Clinical Trials
The United States Food and Drug Administration has officially granted marketing authorization to Eli Lilly and Company for Onswik, chemically…
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FDA Approves Ultragenyx Gene Therapy Fayuvi for Sanfilippo Syndrome Type A at a Record-Breaking $3.95m Price Tag
In a landmark decision for pediatric neurology and rare disease research, the US Food and Drug Administration (FDA) has granted…
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Japan Ministry of Health Labour and Welfare Approves Viatris Wakix Pitolisant for Excessive Daytime Sleepiness and Narcolepsy
Viatris has secured a major regulatory milestone in East Asia as Japan’s Ministry of Health, Labour and Welfare (MHLW) officially…
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European Commission Approves Expanded Use of Crysvita (burosumab) for Infants with X-Linked Hypophosphatemia
Kyowa Kirin EMEA, a subsidiary of Kyowa Kirin, has secured a significant approval from the European Commission (EC) to broaden…
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Canada approves generic semaglutide from Dr. Reddy’s, a G7 first enabled by Novo Nordisk’s lapsed CAD$250 patent
In a landmark decision poised to reshape access to one of the world’s most sought-after medications, Health Canada has granted…
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