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Pharma News

Incyte Gets CRL for Jakafi Extended-Release Tablets
Incyte Gets CRL for Jakafi Extended-Release Tablets
The FDA has told Incyte that it can’t review the company’s new drug application (NDA) for Janus kinase inhibitor Jakafi (ruxolitinib) extended-release (XR) tablets without more supporting data....
NICE Recommends Upstaza for Rare Genetic Disorder
NICE Recommends Upstaza for Rare Genetic Disorder
The UK’s National Institute for Health and Care Excellence (NICE) has recommended PTC Therapeutics’ Upstaza (eladocagene exuparvovec) for National Health Service (NHS) use in treating patients ...
FDA Approves First-Ever Treatment for Activated Phosphoinositide 3-Kinase Delta Syndrome
FDA Approves First-Ever Treatment for Activated Phosphoinositide 3-Kinase Delta Syndrome
The FDA has approved Pharming’s Joenja (leniolisib) twice-daily tablets as the first treatment for adult and pediatric patients 12 years and older with activated phosphoinositide 3-kinase delta s...
AstraZeneca and Ionis build case for amyloidosis drug eplontersen
AstraZeneca and Ionis build case for amyloidosis drug eplontersen
AstraZeneca and Ionis are waiting for an FDA decision on their new therapy for one of the complications of the disease transthyretin amyloidosis (ATTR) later this year, and now have new data sugges...
AbbVie Hits Snag for Parkinson’s Disease Candidate
AbbVie Hits Snag for Parkinson’s Disease Candidate
The FDA said it could not approve AbbVie’s new drug application (NDA) for ABBV-951 (foslevodopa/foscarbidopa), an investigational therapy for advanced Parkinson’s disease, because of concerns a...
FDA Approves Sandoz’s Citrate-Free Adalimubab Formulation
FDA Approves Sandoz’s Citrate-Free Adalimubab Formulation
The FDA has approved Sandoz’s citrate-free high-concentration formulation of its biosimilar Hyrimoz (adalimumab-adaz) injection for seven of the approved indications of AbbVie’s Humira (adalimu...
FDA Approves Sandoz’ High-Concentration Version of Adalimumab Biosimilar, Hyrimoz
FDA Approves Sandoz’ High-Concentration Version of Adalimumab Biosimilar, Hyrimoz
Both the high-concentration and low-concentration versions of adalimumab-adaz (Hyrimoz) injection will launch in July, along with a wave of other biosimilars to Humira (reference adalimumab). ...
Arkansas Drug Manufacturer Draws FDA Warning Letter
Arkansas Drug Manufacturer Draws FDA Warning Letter
Dunagin Pharmaceuticals of Rogers, Ark., received an FDA warning letter for manufacturing drugs on the same equipment used to manufacture non-drug products and failing to test samples of product co...
FDA Approves Rezzayo, a Novel Echinocandin
FDA Approves Rezzayo, a Novel Echinocandin
The FDA approved rezafungin for injection (Rezzayo, Cidara Therapeutics/Melinta Therapeutics), a novel echinocandin, for the treatment of candidemia and invasive candidiasis in adults 18 years of a...
FDA Issues Warning Letter on Nyquil
FDA Issues Warning Letter on Nyquil
The FDA has accused Procter & Gamble (P&G) of submitting one ingredient list for Nyquil to the agency and using a different one for the over-the-counter product’s physical labeling. ...
EU Authorizes Dupixent for Young Kids With Severe Atopic Dermatitis
EU Authorizes Dupixent for Young Kids With Severe Atopic Dermatitis

The European Commission has authorized Sanofi’s Dupixent (dupilumab) for use treating children six months years old to five years i

n the EU.
FDA Approves Evkeeza for Kids With Ultra-Rare Cholesterol Disorder
FDA Approves Evkeeza for Kids With Ultra-Rare Cholesterol Disorder
The FDA has expanded Regeneron’s Evkeeza (evinacumab-dgnb) approval to include treatment of children aged five years old to 11 suffering from homozygous familial hypercholesterolemia (HoFH), an u...
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