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The U.S. Food and Drug Administration has awarded its first approval in the specific interleukin-23 inhibitor space for Crohn’s disease to AbbVie’s Skyrizi I (risakizumab-rzaa). 

Despite the Biden administration’s pledge to end formula shortages, slow responses and requests for more information from the U.S. Food and Drug Administration (FDA) have led to weeks-long delays for baby formula makers seeking U.S. approval, the two companies told Reuters.

Amylyx Pharmaceuticals Inc.’s experimental drug for the neurodegenerative disease amyotrophic lateral sclerosis (ALS) would be more cost effective than other U.S.-approved treatments if priced around $170,000, an independent U.S. pricing watchdog said on Tuesday.

Mallinckrodt plc today announced the company has resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration for the investigational agent terlipressin to treat adults with hepatorenal syndrome (HRS) involving rapid reduction in kidney function.

Advisers to the U.S. Food and Drug Administration on Thursday voted to recommend approval of bluebird bio’s treatment for a rare neurological disorder, bringing it closer to becoming the third gene therapy to be available in the United States.

Pfizer Inc. and partner BioNTech completed the filing with the U.S. drugs regulator seeking authorization for their COVID-19 vaccine in children under 5 years of age.

The U.S. Food and Drug Administration said on Wednesday it has withdrawn the health regulator’s approval for TG Therapeutics Inc.’s lymphatic cancer treatment Ukoniq over concerns of higher risk of death in patients receiving the drug.

The long weekend saw three established drugs developed by Bristol Myers Squibb, Novartis, and Roche score new approvals from the U.S. Food and Drug Administration.

United Therapeutics announced on Tuesday that the company received U.S. Food and Drug Administration approval for its therapeutic Tyvaso DPI. Tyvaso DPI marks the first approval of a dry powder inhaler for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).