The Pharma Data

NOVEMBER 17, 2021

Now, new research led by investigators at Harvard Medical School and Boston Children’s Hospital points to a well-known and widely available drug called disulfiram as a possible treatment for COVID-19. The drug is FDA-approved and has been prescribed for over 60 years as a treatment for alcoholism.

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Drug Target Review

AUGUST 29, 2024

MR : Chimeric antigen receptor T-cell (CAR-T) therapy is very effective in treating patients with B-cell lymphoma, leukemia, and multiple myeloma, where we have six FDA-approved drugs. What potential advantages does the CD5 modulation strategy offer over traditional CAR-T therapies?

Therapies 59

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The Pharma Data

APRIL 7, 2021

Prior to the FDA approval of Trodelvy, patients with previously treated metastatic TNBC had few treatment options in this high unmet-need setting. The FDA granted accelerated approval to Trodelvy in April 2020 based on objective response rate and duration of response results in a Phase 1/2 study.

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The Pharma Data

JANUARY 24, 2021

Food and Drug Administration (FDA) approval for the prevention of VTE in all cancer types based on these two Phase 3 studies. ZUG, Switzerland , Jan. These patents are related to key thrombotic inhibitor pathways, including P-selectin.

Licensing 40

Licensing Licensing Clinical Trials Medical Schools 40

DrugBank

FEBRUARY 12, 2025

The National Institutes of Health (NIH) Clinical Collection , a library of FDA-approved drugs, is widely used for HTS in drug repurposing initiatives. For example, researchers at Harvard Medical School explored the association between the use of anti-inflammatory medications and the risk of developing Parkinson's disease.

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Cell Based Assays Drugs Pharmacokinetics Disease 52

Agency IQ

JUNE 7, 2024

However, this means that substances that were already available as dietary ingredients prior to their sponsors submitting an IND or obtaining FDA approval may still be marketed as such. L-glutamine offers an example of a more recently approved drug product. FDA’s problems with supplement oversight go well beyond just NDIs.

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FDA Science Production FDA Approval 40

The Pharma Data

NOVEMBER 5, 2020

The approval by the US Food and Drug Administration (FDA) was based on positive results from the THALES Phase III trial that showed aspirin plus BRILINTA 90mg significantly reduced the rate of the composite of stroke and death compared to aspirin alone in patients with acute ischemic stroke or TIA. INDICATIONS.

Disease 40

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The Pharma Data

DECEMBER 15, 2020

In late 2020, the effort received $200,000 in seed funding from the Baker Department of Cardiometabolic Health at the University of Melbourne’s medical school. Scientists will be testing a drug class targeting the C-reactive protein (CRP) marker of acute inflammation in the body.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

Drug Target Review

FEBRUARY 15, 2024

12 That drug (tecovirimat) is now FDA-approved and stockpiled by the US and other governments for smallpox treatment, 13 while also being used in clinical practice globally for treatment of mpox and other viruses within the orthopox family. He currently serves as Chief Medical Officer at SIGA Technologies.

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Drug Development Virus Vaccine Government 122

Broad Institute

NOVEMBER 6, 2024

Kerry Reynolds: The first immune checkpoint inhibitor was FDA-approved in 2011 to treat melanoma, with nearly a dozen more ICIs approved for various cancers since then. How big of a problem are these complications from cancer immunotherapy?

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Research Immune Response Hospitals Therapies 131

Drug Target Review

MARCH 20, 2025

” In addition to AFib, Anthos Therapeutics is also investigating abelacimab’s potential in cancer-associated thrombosis, for which there are currently no FDA approved products. These studies, anticipated to complete in 2027, could open doors for abelacimab’s approval in this indication.

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Therapies Trials Clinical Development FDA 52

Drug & Device Law

DECEMBER 29, 2023

The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law. See 2023 Mich.

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Testimonials Drugs FDA Vaccine 105

Drug & Device Law

NOVEMBER 3, 2022

Plaintiff’s expert’s third alternative design was a synthetic product, but the product was not on the market at the time of plaintiff’s surgery and has never been approved by the FDA. He was not allowed to testify regarding adverse event reporting or defendants’ compliance with FDA requirements.

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