New Drug Approvals

JULY 25, 2025

2025, 68, 2147−2182 Vamorolone (Agamree). “Population Pharmacokinetics of Vamorolone (VBP15) in Healthy Men and Boys With Duchenne Muscular Dystrophy” Journal of Clinical Pharmacology. Retrieved 11 February 2025. Nagaraju, J.M. Damsker, J.M. 21 (2013) 2241–2249. 77 Readily available steroid 9.1 PMC 6548694.

FDA

New Drug Approvals

APRIL 19, 2025

“Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025. August 2000). 68 (2): 14350. doi : 10.1067/mcp.2000.108733.

FDA

Agency IQ

JULY 8, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA

Agency IQ

JUNE 16, 2023

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. The anticipated date of publication is June 2023, meaning we should see this regulation imminently. Read our analysis of that rule here and here. ] the drug and device) of the combination product.

Regulations

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

FDA

Agency IQ

FEBRUARY 15, 2024

CDER, CBER Draft 12/29/2025 FDA must issue final guidance no later than 18 months after the close of the public comment period for draft guidance. Priority B List. use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

FDA

Agency IQ

FEBRUARY 2, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA