Pharma News

The FDA has granted Orphan Drug designation to Cyclerion Therapeutics’ investigational drug zagociguat for treatment of mitochondrial diseases.

The FDA has approved Glenmark Pharmaceuticals’ generic version of Leo Pharma’s Enstilar (calcipotriene and betamethasone dipropionate), for topical treatment of plaque psoriasis. ...

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....

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 ...

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 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...

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...

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...

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). ...

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...

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...

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. ...