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. “Successful Treatment of Refractory Electrical Storm With Landiolol After More Than 100 Electrical Defibrillations” International Heart Journal.

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FDA Clinical Trials Treatment Trials 62

New Drug Approvals

DECEMBER 24, 2023

1] Society and culture Names Eplontersen is the international nonproprietary name. [9] “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. 88 (12): 5389–5398. doi : 10.1111/bcp.15468.

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Clinical Trials FDA Clinical Pharmacology FDA Approval 62

Agency IQ

JULY 8, 2024

The following PDUFA dates were obtained from publicly available sources.

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FDA Science Regulations Production 40

Agency IQ

JUNE 16, 2023

0910-AI78 June 2023 May 2023 Final Rule Stage Sunlamp Products; Amendment to the Performance Standard FDA is updating the performance standard for sunlamp products and ultraviolet lamps intended for use in these products to improve safety, reflect new scientific information, and work towards harmonization with international standards.

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Regulations FDA Science Production 40

Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

Pharma Companies 111

Pharma Companies Licensing Licensing Disease 111

Agency IQ

JUNE 2, 2023

By harmonizing with the International Electrotechnical Commission, this rule will decrease the regulatory burden on industry and allow the Agency to take advantage of the expertise of the international committees, thereby also saving resources. The following PDUFA dates were obtained from publicly available sources.

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FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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FDA Science Regulations Production 40