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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Targeted Cancer Therapies02:57

Targeted Cancer Therapies

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The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
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Drug Regulation01:25

Drug Regulation

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Treatment Resistant Cancers02:56

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Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
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CRISPR01:59

CRISPR

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Genome editing technologies allow scientists to modify an organism’s DNA via the addition, removal, or rearrangement of genetic material at specific genomic locations. These types of techniques could potentially be used to cure genetic disorders such as hemophilia and sickle cell anemia. One popular and widely used DNA-editing research tool that could lead to safe and effective cures for genetic disorders is the CRISPR-Cas9 system. CRISPR-Cas9 stands for Clustered Regularly Interspaced...
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Pharmacovigilance01:19

Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
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Related Experiment Video

Updated: Mar 7, 2026

Silencing of BRCA2 to Identify Novel BRCA2-regulated Biological Functions in Cultured Human Cells
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Rucaparib: First Global Approval.

Yahiya Y Syed1

  • 1Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|March 2, 2017
PubMed
Summary

Rucaparib is an oral PARP inhibitor approved for BRCA-mutated advanced ovarian cancer. This marks a significant milestone in targeted therapy development for solid tumors.

Area of Science:

  • Oncology
  • Pharmacology
  • Genetics

Background:

  • Rucaparib (Rubraca™) is an oral small molecule poly (ADP-ribose) polymerase (PARP) inhibitor.
  • Developed by Clovis Oncology, Inc. for solid tumor treatment.
  • Targeting DNA damage repair pathways.

Purpose of the Study:

  • Summarize the development milestones of rucaparib.
  • Highlight its first approval for ovarian cancer.
  • Provide an overview of its therapeutic potential.

Main Methods:

  • Review of preclinical and clinical development data.
  • Analysis of regulatory submission and approval processes.
  • Examination of ongoing clinical investigations.

Main Results:

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  • Rucaparib received US FDA approval as monotherapy.
  • Indicated for patients with deleterious BRCA mutation-associated advanced ovarian cancer.
  • Patients must have received two or more prior chemotherapies.

Conclusions:

  • Rucaparib represents a significant advancement in targeted cancer therapy.
  • Its development highlights the importance of PARP inhibition in BRCA-mutated cancers.
  • Further investigations are ongoing for ovarian, breast, and prostate cancers.