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Sanofi’s rare disease drug gets world’s first approval in Japan

The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for Xenpozyme® (olipudase alfa) for the treatment of adult and pediatric...

Novartis targeted radiation therapy gets FDA nod for PSMA

Novartis announced today that the US Food and Drug Administration (FDA) approved Pluvicto™(lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with...

Pharmacovigilance risk assessment committee: Spikevax and Comirnaty mRNA vaccines

European Medicines Agency has published Meeting highlights from the Pharmacovigilance Risk Assessment Committee  (PRAC) 7-10 March 2022. COVID-19 Vaccine Janssen: small vessel vasculitis added as...

US FDA approves donepezil transdermal patch for treatment of Alzheimer disease

Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced on Monday the U.S. Food...

Lawmakers in the U.S. push for a permanent ban on illicit versions of fentanyl

A bipartisan trio of U.S. Congressmen on Monday unveiled new legislation that would permanently ban illicit versions of fentanyl, the powerful synthetic painkiller that...

U.S FDA approves expanded use of Bristol Myers lung cancer medication

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Opdivo®(nivolumab) in combination with platinum-doublet chemotherapy for adult patients with resectable...
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