Drug Target Review

JUNE 16, 2025

Unlike traditional pharmacokinetic (PK) studies that rely on plasma measurements alone, MSI, when combined with traditional histology, enables spatial mapping of drug distribution, metabolism and target engagement. Multimodal Imaging Distribution Assessment of a Liposomal Antibiotic in an Infectious Disease Model.

Drugs 52

Drugs Organic Chemistry Laboratories Pharmaceuticals 52

The Pharma Data

JUNE 11, 2025

Conducted in healthy adult volunteers, these studies were designed to evaluate the pharmacokinetics and establish bioequivalence between the new tablet and the original capsule form. The rollout of the tablet formulation is expected to begin in October 2025, with BRUKINSA tablets replacing the current capsule offering in the U.S.

FDA Approval 40

FDA Approval FDA Treatment Therapies 40

PPD

OCTOBER 12, 2023

Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes. However, key differences between PCR assays and immunotherapeutic assays must be considered.

Laboratories 52

Laboratories Clinical Trials Protein Expression Pharmacokinetics 52

New Drug Approvals

APRIL 18, 2025

4] A medication used to reduce the amount of steroid replacement required in patients with a genetic disease that causes, amongst other symptoms, a steroid deficiency. Retrieved 25 January 2025. January 2025. Archived from the original on 21 January 2025. . : 321839-75-2 Molecular Weight 519.50 1] It is taken by mouth. [1]

FDA 62

FDA FDA Approval Drugs Trials 62

Drug Target Review

JULY 1, 2024

As a non-NSAID, it reduces adverse effects associated with these pain relief drugs, including kidney injury, GI gastritis/ulceration and blood pressure elevation, which can affect patients with cardiovascular disease and the elderly. We set out to improve health by developing a novel non-opioid that avoids potential abuse.

Treatment 59

Treatment Clinical Trials Therapies Molecular Biology 59

New Drug Approvals

SEPTEMBER 13, 2024

2] [3] [4] A regulatory application for approval of the medication is expected to be submitted by 2025. [2] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 2] [3] [4] A regulatory application for approval of the medication is expected to be submitted by 2025. [2] 2] Aticaprant is taken by mouth. [1]

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Agency IQ

AUGUST 9, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time. When would the guidance go into effect?

Science 40

Science FDA Production Drugs 40

The Pharma Data

JANUARY 10, 2021

In 2019, we introduced Vision 3×3, the company’s strategic roadmap through 2025, to build a leading biopharma company by achieving sustainable growth through multiple approaches. Independently optimized receptor bias and potency as well as pharmacokinetics to create a potentially best-in-class IL-2 product. .

Clinical Trials 40

Clinical Trials Clinical Development Small Molecule Trials 40

Covalent Modifiers

JULY 8, 2025

2025 [link] The coronavirus disease 2019 (COVID-19) pandemic crisis has been mitigated by worldwide efforts to develop vaccines and therapeutic drugs. Subsequent optimization efforts yielded S-892216, which combined a favorable pharmacokinetic profile and high off-target selectivity.

Pharmacokinetics 130

Pharmacokinetics Vaccine Disease Drugs 130

The Pharma Data

JUNE 9, 2025

Sanofi Ramps Up Early Global Distribution of Beyfortus to Meet Growing RSV Season Demand, Enhancing Protection for Infants Worldwide In a proactive move to ensure readiness for the 2025-2026 respiratory syncytial virus (RSV) season, Sanofi has announced that shipments of Beyfortus® (nirsevimab) will begin in early Q3 2025.

Virus 40

Virus Hospitals Vaccine Immune Response 40

Agency IQ

JULY 28, 2023

This assessment is due to be published for public comment by June 30, 2025 , will a public meeting to be held by September 30, 2025 “to discuss the report, its findings, and the Agency’s specific plans to address the report recommendations.” Read the full AgencyIQ analysis here.

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40

FDA Law Blog: Drug Discovery

JULY 9, 2024

This could be based on differential pharmacokinetics (“PK”) or pharmacodynamics (“PD”), possible differences in susceptibility to specific adverse events of concern, or due to differential presentation of the disease or condition. intended use population. population demographics. population in light of the U.S. role in global health.

FDA 59

FDA Clinical Trials Disease Trials 59

Alta Sciences

JULY 31, 2024

Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. Similarly, more than 90% of people in the United States with sickle cell disease are Black, with an estimated three to nine percent being Hispanic or Latino.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Drug Development 52

Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

JUNE 28, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time. What about rare diseases?

FDA 40

FDA Science Clinical Trials Production 40

The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. BNT162 mRNA-based Vaccine Program.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

New Drug Approvals

MAY 14, 2025

7] This pharmacokinetic property has supported its investigation for the treatment of deep-seated Candida infections, including osteomyelitis. [8] Albanell-Fernndez M (January 2025). Grasselli Kmet N, Luzzati R, Monticelli J, Babich S, Conti J, Bella SD (March 2025). 23 March 2023. 64 (1): 2752. doi : 10.1007/s40262-024-01461-5.

Pharmacokinetics 62

Pharmacokinetics FDA FDA Approval Treatment 62

New Drug Approvals

APRIL 5, 2025

7] Treosulfan was authorized for medical use in the European Union in June 2019, [9] and approved for medical use in the United States in January 2025. [7] 7] Treosulfan was authorized for medical use in the European Union in June 2019, [9] and approved for medical use in the United States in January 2025. [7] 14 January 2025.

FDA 62

FDA FDA Approval Production Treatment 62

New Drug Approvals

MAY 11, 2025

5] The condition can also cause heart disease. [5] 5] This disease tends to develop in children and teenagers and gradually worsens over time. [5] 5] The mFARS is a clinical assessment that measures disease progression, namely swallowing and speech (bulbar), upper limb coordination, lower limb coordination, and upright stability. [5]

FDA 57

FDA FDA Approval Disease Production 57

Drug Target Review

APRIL 21, 2025

LB Pharmaceuticals is making significant strides in the field of drug discovery, particularly in the development of therapies for neuropsychiatric diseases such as schizophrenia. The road ahead The next step for LB-102 is the initiation of pivotal Phase III trials, expected to launch in late 2025.

Treatment 59

Treatment Drugs Clinical Trials Trials 59

New Drug Approvals

APRIL 21, 2025

3] Revumenib was administered until disease progression, unacceptable toxicity, failure to achieve morphological leukemia-free state by four cycles of treatment, or hematopoietic stem cell transplantation. [3] January 2025. Archived from the original on 21 January 2025. 7] It is sold under the brand name Revuforj. [1]

FDA Approval 67

FDA Approval FDA Clinical Trials Pharmaceuticals 67

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] 1] [6] [10] ATTR-CM is a rare and serious disease that affects the heart muscle. [6] 2] Acoramidis was authorized for medical use in the European Union in February 2025. [2]

FDA Approval 62

FDA Approval FDA Production Treatment 62

Codon

FEBRUARY 23, 2025

In January 2025, the incoming Trump administration issued a 90-day freeze on PEPFAR while it conducts a “programmatic efficiencies” review. For that reason, long-term preventatives are probably a better strategy for controlling the disease. By February, the U.S. Jerome Horwitz and Wolfram Ostertag.

Clinical Trials 77

Clinical Trials Virus Vaccine DNA 77