The Latest Breaking News from FDA

Reexamining a trade deal with bipartisan support

U.S. indices finished Thursday's trading session lower. Worse-than-expected retail earnings and anticipation of further Federal Reserve policy tightening in 2022 have continued to weigh on stocks across sectors.

An Abbott baby formula plant in Michigan that’s been shut down since February could be up and running as early as next week, the head of the Food and Drug Administration told lawmakers Thursday.

Why is there an infant formula shortage in the US? Who is to blame? And when will parents see relief?

But Abbott has said that, after production resumes, it could take about two months before new formula begins arriving in stores. The company's factory has been closed due to contamination problems.

The U.S. National Institutes of Health and Pfizer Inc (NYSE:PFE) are discussing testing a longer course of COVID-19 antiviral treatment Paxlovid, required to prevent reinfections, White House Chief Medical Officer Anthony Fauci said. "We're going to be planning what studies we're going to be doing relatively soon, within the next few days," to…

Abbott Laboratories (NYSE:ABT) and the FDA are reportedly on track to reopen the company's Sturgis, Michigan, baby formula manufacturing plant within one or two weeks, FDA Commissioner Robert Califf said. Abbott, the biggest U.S. supplier of powder infant formula, including Similac, agreed with the FDA on the steps needed to resume production at…

Immunome Inc (NASDAQ:IMNM) shares are trading higher after it published data demonstrating that its COVID-19 antibody cocktail, IMM-BCP-01, potently cleared the omicron variant (BA.1) when tested in vivo in hamsters.  Additional in vitro testing of a SARS-CoV-2 pseudovirus showed that IMM20253, one of the antibodies in Immunome's cocktail, successfully neutralized the omicron subvariant…

The FDA approved the intravenous (IV) formulation of SIGA Technologies Inc's (NASDAQ:SIGA) TPOXX for smallpox. The oral formulation of TPOXX (tecovirimat) is approved in the US, Canada, and Europe to treat smallpox.  The European approval also includes the treatment of monkeypox, cowpox, and complications from immunization with vaccinia.  The IV formulation of TPOXX was…

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional approval for Calliditas Therapeutics AB's (NASDAQ:CALT) Kinpeygo for primary immunoglobulin A (IgA) nephropathy (IgAN). The opinion covers adult patients at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.  Also See: Calliditas…

Markets work if you let them. The Biden administration and Congress should remove supply restraints on baby formula that never made any sense in the first place.