Sanofi’s Rare Disease Drug Xenpozyme Scores FDA Approval
Soon after the European Commission’s (EC) approval, Sanofi SA (NASDAQ:SNY) scooped up the FDA’s OK for the first approved therapy to treat symptoms…
Amneal Announces Submission of New Drug Application to the U.S. FDA for IPX203 for the Treatment of Parkinson’s Disease
- IPX203 is a novel, extended-release oral formulation of carbidopa and levodopa that if approved, would offer patients more "Good On" time with fewer doses
Amneal Pharmaceuticals, Inc. (NYSE:AMRX)
Bluebird bio Seeks Back-to-Back Nods, ‘Go’ or ‘No-Go’ For Revance’s Botox Rival, Amylyx’ Twin Hurdles And More: September’s Key PDUFA Catalysts Biotech Investors Must Know
After August’s mixed tally for Food and Drug Administration approvals, investors turn to a new month, which has a fairly loaded calendar.
Xenpozyme Approved By FDA As First Disease-Specific Treatment For ASMD
Paris, August 31, 2022. The U.S. Food and Drug Administration (FDA) has approved XenpozymeTM (olipudase alfa-rpcp) for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinaseParis, August 31, 2022. The U.S.
Landos Biopharma Receives Notice Of Allowance For U.S. Patent Titled ‘NLRX1 LIGANDS (TO TREAT MANY CONDITIONS INCLUDING ALZHEIMER’S DISEASE AND PARKINSON’S DISEASE)’
https://patentcenter.uspto.gov/#!/applications/17479337/ifw/docs
Ascendis Seeks FDA Nod For TransCon PTH In Adults With Hypoparathyroidism
Ascendis Pharma (NASDAQ: ASND) has submitted a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for TransCon PTH, an investigational pro-drug designed to restore parathyroid hormone (PTH [1-34]) to physiological levels over 24 hours in adult patients with hypoparathyroidism.
Moderna Receives FDA Authorization For Emergency Use Of Omicron-Targeting Bivalent COVID-19 Booster Vaccine For Adults 18 Years And Older
Moderna's Bivalent Booster Shots to be Available Nationwide In Coming Days
mRNA-1273.222 Targets BA.4/.5 Strains of Omicron Variant
CAMBRIDGE, MA / ACCESSWIRE / August 31, 2022 / Moderna, Inc. (NASDAQ:MRNA), a
Pfizer And BioNTech Granted FDA Emergency Use Authorization Of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster For Ages 12 Years And Older
Authorization based on clinical, pre-clinical and manufacturing data for Omicron-adapted bivalent vaccines
Pfizer-BioNTech Omicron BA.4/BA.5 bivalent vaccine combines 15-µg of mRNA encoding the wild-type