FDA Prioritises Review of Amgen’s Tarlatamab for Advanced Small Cell Lung Cancer
In a significant development for the fight against advanced small cell lung cancer (SCLC), the U.S. Food and Drug Administration
Read more
Regulatory
EC Greenlights KAFTRIO® Combo for Cystic Fibrosis
Vertex Pharmaceuticals Incorporated has announced that the European Commission (EC) has approved the label expansion of KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a
Read more
FDA Approves the World’s First Vaccine Against Chikungunya Virus
In a groundbreaking development for the vaccine development sector, biotech company Valneva SE announced, that the U.S. Food and Drug
Read more
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
Read more
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
Read more
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
Read more
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,
Read more
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
Read more
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
Read more
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,
Read more