Pharma News, 2023

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. ...

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

n the EU.

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...

AbbVie Inc (ABBV.N) said on Wednesday the U.S. Food and Drug Administration had declined to approve its Parkinson's disease therapy for adults and had requested for more information on the device ...

Fusion Pharmaceuticals Inc., a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the first patient has been dos...

The FDA has cleared Diamond Therapeutics’ investigational new drug application for a clinical trial evaluating the effects of repeat low doses of psilocybin in patients with demoralization. ...