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Search articles in Regulatory Affairs

Found 68 articles

  • IQVIA Named a Leader in Medical Affairs and Regula

    IQVIA Named a Leader in Medical Affairs and Regulatory Operations by Everest Group

    • 12 Jul 2024
    • Editor

    IQVIA™ (NYSE:IQV) today announces that a leading, independent research firm, Everest Group, has recognized IQVIA as a Leader in its Life Sciences Regulatory and Medical Affairs Operations PEAK Matrix® Assessment 2024 survey, which measures both market impact and delivery effectiveness.

  • Truqap plus Faslodex approved in the EU for patien

    Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer

    • 20 Jun 2024
    • Editor

    AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the European Union (EU) for the treatment of adult patients with estrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen.

  • Current State of the Regulatory Contract Recruitme

    Current State of the Regulatory Contract Recruitment Market in the Life Science Industry

    • 11 Jun 2024
    • Jasmine Smith, ARM

    The regulatory contract recruitment market within the life science industry is currently experiencing significant growth and transformation. Over the last year or so, the market has been difficult, marked by unpredictability and challenges.

  • Tagrisso granted Priority Review in the US for pat

    Tagrisso granted Priority Review in the US for patients with unresectable, Stage III EGFR-mutated lung cancer

    • 10 Jun 2024
    • Editor

    AstraZeneca’s supplemental New Drug Application (sNDA) for has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT).

  • European Commission approves Roche’s Alecensa as t

    European Commission approves Roche’s Alecensa as the first and only targeted adjuvant treatment for people with ALK-positive early-stage lung cancer

    • 10 Jun 2024
    • Editor

    Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved Alecensa® (alectinib) monotherapy, as adjuvant treatment following tumour resection for adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) at high risk of recurrence (Stage IB [≥4 cm]–IIIA NSCLC [7ᵗʰ edition UICC/AJCC]).

  • Moderna's Investigational Therapeutic for Methylma

    Moderna's Investigational Therapeutic for Methylmalonic Acidemia (mRNA-3705) Selected by U.S. Food & Drug Administration for START Pilot Program

    • 7 Jun 2024
    • Editor

    Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has selected mRNA-3705 for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. mRNA-3705 is an investigational therapeutic for methylmalonic acidemia (MMA) due to methylmalonic-CoA mutase (MUT) deficiency.

  • FDA grants Priority Review to Roche’s inavolisib f

    FDA grants Priority Review to Roche’s inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

    • 30 May 2024
    • Editor

    Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application and granted Priority Review to inavolisib, an investigational, oral therapy, in combination with palbociclib (Ibrance®) and fulvestrant.

  • Zanidatamab Granted Priority Review for HER2-Posit

    Zanidatamab Granted Priority Review for HER2-Positive Metastatic Biliary Tract Cancer

    • 30 May 2024
    • Editor

    Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of the Biologics License Application (BLA) for zanidatamab, the human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, for the treatment of previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC).

  • Roche granted FDA Breakthrough Device Designation

    Roche granted FDA Breakthrough Device Designation for blood test measuring Lp(a) – a key marker for hereditary cardiovascular risk

    • 22 May 2024
    • Editor

    Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Tina-quant® lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from innovative Lp(a)-lowering therapy currently in development.

  • Bristol Myers Squibb Announces Updated Action Date

    Bristol Myers Squibb Announces Updated Action Date by the U.S. Food and Drug Administration for Subcutaneous Nivolumab (nivolumab and hyaluronidase)

    • 22 May 2024
    • Editor

    Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has reassigned the previously announced Prescription Drug User Fee Act (PDUFA) goal date of the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo ® (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20).

  • FDA grants Breakthrough Therapy Designation to Roc

    FDA grants Breakthrough Therapy Designation to Roche’s inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

    • 21 May 2024
    • Editor

    Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance®) and fulvestrant.

  • Regulatory Careers Live: Join Europe’s only career

    Regulatory Careers Live: Join Europe’s only careers fair dedicated to healthcare regulatory affairs

    • 16 May 2024
    • Editor

    Regulatory Careers Live is Europe's only careers fair dedicated to healthcare regulatory affairs. Book your free place now for TOPRA’s next events in Brussels, Belgium (12 June 2024) and London, UK (11 September, London).

  • Baxter Secures FDA Approval of Clinolipid (Lipid I

    Baxter Secures FDA Approval of Clinolipid (Lipid Injectable Emulsion) Neonatal and Pediatric Indication

    • 14 May 2024
    • Editor

    Baxter International Inc. (NYSE:BAX), a global leader in nutrition therapy, today announced U.S. FDA approval of an expanded indication for Clinolipid (Lipid Injectable Emulsion) to be used in pediatric patients, including preterm and term neonates.

  • What Does a CMC Specialist Do?

    What Does a CMC Specialist Do?

    • 9 May 2024
    • Lucy Walters

    A Chemistry, Manufacturing, and Controls (CMC) Specialist plays a crucial role in the pharmaceutical and biotechnology industries by ensuring that all aspects of the product development process related to chemistry, manufacturing, and controls meet regulatory standards and guidelines.

  • How AI is Transforming Regulatory Affairs

    How AI is Transforming Regulatory Affairs

    • 8 May 2024
    • Editor

    As AI continues to evolve and integrate into various fields, the life sciences industry has begun leveraging this transformational technology to revolutionise regulatory affairs. Given the complexity and volume of regulatory requirements that companies must comply with, AI offers a promising solution to streamline processes and enhance accuracy.

  • Top 10 Skills Required for Careers in Regulatory A

    Top 10 Skills Required for Careers in Regulatory Affairs

    • 7 May 2024
    • Lucy Walters

    Regulatory affairs professionals play a pivotal role in ensuring that pharmaceuticals, biologics, medical devices, and other life science products comply with all the relevant regulations.

  • European Medicines Agency Validates Bristol Myers

    European Medicines Agency Validates Bristol Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the First-Line Treatment of Adult Patients with Microsatellite...

    • 7 May 2024
    • Editor

    Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its Type II variation application for Opdivo® (nivolumab) plus Yervoy ® (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).

  • U.S. Food and Drug Administration Accepts Bristol

    U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Application for Subcutaneous Nivolumab (nivolumab and hyaluronidase)

    • 7 May 2024
    • Editor

    Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “ subcutaneous nivolumab”) across all previously approved adult, solid tumor Opdivo indications as monotherapy...

  • A Recruiter’s Guide to Hiring a Regulatory Affairs

    A Recruiter’s Guide to Hiring a Regulatory Affairs Associate

    • 2 May 2024
    • Lucy Walters

    In this recruiter guide, we explore the essential considerations for you to keep in mind when hiring a Regulatory Affairs Associate. From understanding the unique demands of the role to identifying key competencies and conducting effective interviews, this guide will help you to focus your candidate search and engage your target audience of talent.

  • What Role Does Regulatory Affairs Play in Life Sci

    What Role Does Regulatory Affairs Play in Life Sciences?

    • 1 May 2024
    • Lucy Walters

    In the intricate landscape of the life sciences, the function of regulatory affairs stands as a linchpin, ensuring not only the seamless introduction of innovative medical solutions to the market but also their compliance with stringent legal and ethical standards.