DrugBank

FEBRUARY 12, 2025

This approach capitalizes on prior investments in R&D, mitigates risk by leveraging established safety and pharmacokinetic profiles, and accelerates the delivery of treatments to patients. The National Institutes of Health (NIH) Clinical Collection , a library of FDA-approved drugs, is widely used for HTS in drug repurposing initiatives.

Cell Based Assays 52

Cell Based Assays Drugs Pharmacokinetics Disease 52

New Drug Approvals

APRIL 19, 2025

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 The fast turnover of landiolol will diminish most adverse events due to self-limiting administration. Jump up to: a b “Novel Drug Approvals for 2024” U.S. 32 (2): 828.

FDA 62

FDA Clinical Trials Treatment Trials 62

The Pharma Data

APRIL 11, 2021

In this cohort, the most common treatment-emergent adverse events of any grade (?20%) No patients in this cohort discontinued treatment due to treatment-related adverse events. ” In May 2020, Lilly’s first-in-class selective RET inhibitor Retevmo received Accelerated Approval from the U.S. Retevmo is an U.S.

Research 52

Research Treatment Therapies Trials 52

The Pharma Data

OCTOBER 25, 2020

“We are pleased to continue pursuing additional neuroscience opportunities with BXCL501, targeting agitation associated with delirium, a fifth potential indication for this candidate and a condition for which there is no FDA-approved treatment,” commented Vimal Mehta, Chief Executive Officer of BTI.

Treatment 40

Treatment Trials FDA Hospitals 40

The Pharma Data

DECEMBER 29, 2020

PRX-102 was well-tolerated in the study, with all adverse events being transient in nature without sequelae. The most common moderate treatment emergent adverse events were nasopharyngitis, headache and dyspnea. mL/min/ 1.73m 2 in males, and 86.14 mL/min/ 1.73m 2 in females and plasma lyso-Gb 3 mean levels were 51.81 nM and 13.81

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

AUGUST 30, 2021

For the 16-week treatment period, overall rates of adverse events (AEs) were 64% for Dupixent and 74% for placebo. Significantly improved measures of observed patient outcomes (including sleep, skin pain and health-related quality of life), as well as caregiver-reported health-related quality of life.

Trials 52

Trials Disease Treatment Clinical Trials 52

The Pharma Data

DECEMBER 5, 2020

The most common adverse events (AEs) were cytokine release syndrome (CRS; 39%; n=19), anemia (37%; n=18), fatigue (35%; n=17), nausea (31%; n=15), pyrexia (31%; n=15) and back pain (27%; n=13). 6 months of follow-up, 83% (10 of 12 patients) have ongoing responses for up to 13 months at the time of analysis.

Production 40

Production Trials Treatment Disease 40

The Pharma Data

APRIL 8, 2021

This includes the number of infants able to sit without support for 5 and 30 seconds, a key motor milestone not normally seen in the natural course of the disease, as well as data on event-free survival and reduced hospitalisations. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement.

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

JANUARY 21, 2021

These events may have been associated with inadvertent (partial) intravenous administration and began to resolve within a few minutes after the injection. Hepatotoxicity: Hepatic adverse events were reported. The causal relationship, mechanism, and long-term consequences of these events have not been established.

FDA Approval 52

FDA Approval Treatment RNA FDA 52

The Pharma Data

MAY 5, 2021

It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . A total of 197 patients in the study arm had at least one of the composite endpoint events, compared with 312 patients in the placebo arm. New indications.

FDA Approval 52

FDA Approval FDA Therapies Pharmacokinetics 52

The Pharma Data

FEBRUARY 12, 2022

Nasdaq GILD) moment blazoned new data from an interim analysis of its ongoing, Phase2/3 single arm, open- marker study to estimate the safety, tolerability and pharmacokinetics of Veklury ® (remdesivir) in pediatric cases rehabilitated with COVID-19 with periods ranging from 28 days to lower than 18 times. Gilead Lores,Inc.

Pharmacokinetics 52

Pharmacokinetics RNA Hospitals Laboratories 52

The Pharma Data

MARCH 16, 2021

Decreases in serious adverse events, high-grade adverse events and treatment-related adverse events were observed in the second year versus the first year in both treatment arms. The most common serious adverse events were pneumonia (6.7% and 10%, respectively), nasopharyngitis (21.7% and 0%, respectively).

Pharmacokinetics 52

Pharmacokinetics Treatment Clinical Trials Disease 52

Codon

APRIL 2, 2023

Read Safety and pharmacokinetics of escalating doses of neutralising monoclonal antibody CAP256V2LS administered with and without VRC07-523LS in HIV-negative women in South Africa (CAPRISA 012B): a phase 1, dose-escalation, randomised controlled trial. . Read 🏘️ Events Send me your events. Ricciardi M.J.

DNA 52

DNA RNA Engineering Licensing 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

FEBRUARY 8, 2021

Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. Ischemic cardiovascular events, including events leading to death, occurred in patients receiving ERLEADA ®.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. It is approved in the U.S. Olumiant was recently approved in Japan for the treatment of pneumonia associated with COVID-19 in hospitalized adult patients.

Therapies 52

Therapies Hospitals Treatment FDA Approval 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 most common adverse events (n=21) included fever (pyrexia; 71%), upper respiratory tract infection (52%), cough (33%), vomiting (33%), diarrhea (29%) and respiratory tract infection (29%).

FDA Approval 52

FDA Approval Pharmacokinetics Treatment Clinical Trials 52

The Pharma Data

JANUARY 26, 2021

Across 1,035 patients, there were 11 events (2.1 percent) in patients taking therapy and 36 events (7.0 Serious adverse events were reported at a similar frequency in the bamlanivimab and etesevimab together and placebo groups. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity.

Hospitals 52

Hospitals Treatment Trials Long-Term Care Facilities 52

Metabolite Tales Blog

JANUARY 22, 2025

Metabolism of 2024 FDA approved small molecules part 1 By Julia Shanu-Wilson Involvement of active metabolites The number of small molecules approved by the FDA in 2024 totaled 31 out of 50 NMEs with 56% (28) of these comprising small molecule therapies. Clin Pharmacokinet. What’s next? 2015 May;54(5):457-71.

Small Molecule 52

Small Molecule FDA Approval FDA Pharmacokinetics 52

The Pharma Data

SEPTEMBER 1, 2020

months, 2,039 participants (81.8%) had any treatment-emergent adverse event (TEAE), 236 (9.5%) had a serious TEAE (SAE) and 56 (2.2%) discontinued the study due to a TEAE. Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod. Author: Zhang.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

New Drug Approvals

APRIL 21, 2025

Adverse events were similar in the two groups. [14] 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. Jump up to: a b “Novel Drug Approvals for 2024” U.S. Jump up to: a b “Novel Drug Approvals for 2024” U.S.

FDA Approval 62

FDA Approval FDA Production Treatment 62

Codon

FEBRUARY 23, 2025

Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates.

Clinical Trials 80

Clinical Trials Virus Vaccine DNA 80