FDA
Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.
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Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Shares of Teva Pharmaceuticals jumped more than 7 percent in afternoon trading Thursday and continue to rise in premarket trading this morning after the U.S. Food and Drug Administration approved the company’s generic version of the EpiPen Auto-Injector.
Shares of Sun Pharmaceuticals have climbed more than 3 percent this morning after the U.S. Food and Drug Administration approved its dry eye treatment Cequa (cyclosporine ophthalmic solution) 0.09 percent.
This morning Genentech announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Xolair to treat exposure to those deadly food allergies.
The U.S. Food and Drug Administration (FDA) approved Alnylam Pharmaceuticals’ Onpattro (patisiran) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. It is the first and only RNA interference (RNAi) therapeutic to ever be approved.
This week had three important target action dates, known as Prescription Drug User Fee Act (PDUFA) dates, for the U.S. Food and Drug Administration (FDA). The agency got ahead of its schedule and approved all of these drugs ahead of schedule. Let’s take a look.
GW Pharmaceuticals has finally revealed the price of its cannabis-based epilepsy drug Epidiolex.
The U.S. Food and Drug Administration approved a new generic potassium chloride oral solution under a novel term called the Competitive Generic Therapy designation.
Shares of Novo Nordisk are down about five percent this morning after the company reported an overall decline in sales during the second quarter of this year. Sales were particularly disappointing in North America.
Now that July is over, the U.S. Food and Drug Administration (FDA) appears to be back in full swing with a full docket of drug decisions to make. There are four therapeutics with PDUFA dates this week involving six biopharma companies. Here’s a look.
Shionogi, based in Osaka, Japan and Florham Park, New Jersey, announced that the U.S. Food and Drug Administration (FDA) approved Mulpleta (lusutrombopag) for thrombocytopenia in adults with chronic liver disease who were about to have a medical procedure performed.