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The agency officials also observed problems with the physical plant. The production room, for example, had reoccurring roof leaks that impacted two batches of drug product. Read More
One of the four FDA approvals was Enzyvant Therapeutics’ Rethymic (allogeneic processed thymus tissue-agdc), which was approved for pediatric congenital athymia. Read More
The paper, posted on the MedRxiv.com preprint server, found that Omicron infection increased immunity against Omicron reinfection by 14-fold and immunity against Delta by 4.4-fold. Read More
A federal court has ordered New Jersey-based Natural Solutions Foundation (NSF) to stop selling a “nano silver” solution marketed to prevent and treat coronavirus infections, and to recall and destroy all product distributed this year. Read More
Amylyx Pharmaceuticals has scored a priority review by the FDA for AMX0035 (sodium phenylbutyrate and taurursodiol) as a treatment for amyotrophic lateral sclerosis (ALS). Read More
With 2021 nearly over, LEO Pharma has scored a big victory with Adbry (tralokinumab-ldrm), earning the FDA’s blessing for treating moderate-to-severe eczema (atopic dermatitis). The approval marks the Denmark-based company’s first U.S. biologic. Read More
The hospitals pointed out that two federal courts have ruled drug companies are violating the law and don’t have the right to unilaterally impose these types of restrictions on 340B discounts. Read More
Leqvio works by improving the liver’s ability to prevent the production of a protein that plays a role in keeping circulating cholesterol levels high. Read More
Jeffrey Zients, White House COVID-19 response coordinator, acknowledged in a press briefing that deliveries will be slow to start, especially for Pfizer’s Paxlovid. Read More
FDA investigators observed numerous quality failures during an inspection of a KVK Tech generic drug manufacturing facility in Newton, Penn., ranging from lax cleaning to incomplete investigations of complaints. Read More