The Pharma Data

APRIL 8, 2021

Food and Drug Administration (FDA) approved EVRYSDI for the treatment of SMA in adults and children 2 months of age and older. EVRYSDI was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively.

Clinical Trials 52

Clinical Trials Trials Disease Therapies 52

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The committee also made recommendations regarding pharmacokinetic and safety assessments.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

The Pharma Data

MARCH 16, 2021

TREMFYA is the first and only treatment approved for both adults with moderate to severe plaque PsO and for adults with active PsA that selectively inhibits IL-23, a cytokine that is a key driver of the inflammatory immune response associated with the symptoms of these chronic autoimmune diseases. TREMFYA was approved in the U.S.

Treatment 52

Treatment Disease Pharmacokinetics Therapies 52

The Pharma Data

MARCH 16, 2021

Food and Drug Administration (FDA) approved Evrysdi for the treatment of SMA in adults and children 2 months of age and older in August of 2020. Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively.

Pharmacokinetics 52

Pharmacokinetics Treatment Clinical Trials Disease 52

The Pharma Data

FEBRUARY 25, 2021

The FDA approved Evrysdi in August 2020 as the first and only at home SMA treatment with proven efficacy in adults, children and infants 2 months and older. Food and Drug Administration (FDA) approved Evrysdi for the treatment of SMA in adults and children 2 months of age and older. mg/kg for Part 2.

FDA Approval 52

FDA Approval Pharmacokinetics Treatment Disease 52

The Pharma Data

SEPTEMBER 27, 2020

In August, the FDA approved Evrysdi for the treatment of SMA in adults and children 2 months and older. The FDA approved Evrysdi for the treatment of SMA in adults and children 2 months of age and older. 59% of infants were able to sit without support for at least 5 seconds. No new safety signals were identified.

FDA Approval 52

FDA Approval Pharmacokinetics Treatment Clinical Trials 52

The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. FDA on April 28, 2011 and by the European Commission on September 7, 2011. FDA on February 8, 2018. [vi] vi] Since its first approval in the U.S. 2 ERLEADA ® received U.S.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

New Drug Approvals

MAY 30, 2025

PATENT [link] PATENT CN112457267 [link] REF Satish Kumar RangarajuSatish Kumar Rangaraju The first FDA-approved treatment for Demodex Blepharitis, a common eyelid disease caused by microscopic mites living in the eyelashes’ hair follicles. Food and Drug Administration (FDA). Food and Drug Administration (FDA).

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Drug Target Review

APRIL 25, 2025

Addressing the gaps associated with liver-on-chips, a recent 3D hepatic spheroid study predicted DILI liabilities of 152 FDA-approved small molecules using a high-throughput 384 well plate-based system with a sensitivity of 72 percent and specificity of 89 percent. Nature Communications 2017 8:1 8 (2017) 18.

Clinical Development 52

Clinical Development Small Molecule Drugs FDA Approval 52

New Drug Approvals

MAY 22, 2025

Retrieved 25 May 2023. ^ “Sulperazon” drugs.com. ^ “FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria” U.S. “Pharmacokinetics and Pharmacodynamics of -Lactamase Inhibitors” Pharmacotherapy. Food and Drug Administration (Press release). 24 May 2023.

Pharmacokinetics 62

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New Drug Approvals

APRIL 21, 2025

6] Acoramidis was approved for medical use in the United States in November 2024, [6] [7] [8] [9] and in the European Union in February 2025. [2] Jump up to: a b c d e f g h i j k “FDA approves drug for heart disorder caused by transthyretin-mediated” U.S. Food and Drug Administration (FDA). 61 (17): 78627876.

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