• RoundupsRoundups

    FDA Approvals Roundup: StrataGraft, Rezipres, Trikafta

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals StrataGraft greenlighted for treating thermal burns in adults Mallinckrodt’s StrataGraft has been approved as a topical application treatment for adults with thermal burns containing intact deep skin layers for which surgical intervention is clinically indicated.   Deep thermal burns often require the removal of damaged skin and replacement ...
  • Feature ArticlesFeature Articles

    May’s Regulatory Focus: EU MDR and EU IVDR update, and more

    Feature articles during May focused on the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostic Regulation (IVDR). The 26 May deadline for the MDR has come and gone, and the regulation is now being fully applied after a yearlong delay because of the pandemic. Next up is the application deadline for the IVDR, now set for 26 May 2022. Articles in this issue examined the extent of preparedness among regulators, sponsors, and manufacturers for the two application ...
  • RoundupsRoundups

    FDA Approvals Roundup: Aduhelm, Brexafemme, Tembexa

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Aduhelm okayed for slowing Alzheimer’s by targeting disease-driving process Biogen’s Aduhelm (aducanumab) has received accelerated approval for treating patients with Alzheimer’s disease, making it the first new treatment for the disease since 2003.   The human monoclonal antibody is also a first-of-its kind therapy for the disease in that...
  • RoundupsRoundups

    FDA Approvals Roundup: Pylarify, Lybalvi, Lumakras

    New approvals Pylarify cleared for PSMA-targeted PET imaging in prostate cancer Progenics’ Pylarify (piflufolastat F 18 injection) has been approved for use in positron emission tomography (PET) imaging of prostate-specific membrane antigen‒positive lesions in men with prostate cancer with suspected metastasis or recurrence.   The approval of Pylarify, a radioactive diagnostic agent, was based on safety and efficacy findings from the OSPREY and CONDOR t...
  • RF Quarterly

    RF Quarterly, June 2021: Artificial intelligence in global regulatory practice

    Welcome to the summer issue of RF Quarterly in which international experts from the UK, EU, Saudi Arabia, Hong Kong, and the US have come together to examine and dissect the role of artificial intelligence (AI) in healthcare and its impact on global regulatory practice.   Advances in AI technologies are transforming healthcare delivery and hold promise for improving patient outcomes. However, these complex technologies have introduced new challenges, especially aroun...
  • RoundupsRoundups

    FDA Approvals Roundup: Rybrevant, Lymphoseek, Opdivo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Rybrevant nabs accelerated approval for metastatic NSCLC with EGFR mutations Janssen’s Rybrevant (amivantamab-vmjw injection) has been granted accelerated approval for treating locally advanced or metastatic non‒small cell lung cancer (NSCLC) in adults with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has pro...
  • RoundupsRoundups

    FDA Approvals Roundup: Zynrelef, Empaveli, Ingrezza

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Zynrelef cleared as long-acting combination therapy for postoperative pain Heron’s Zynrelef (bupivacaine and meloxicam) extended-release solution has been approved as a postsurgical analgesic lasting for up to 72 hours in adults who have undergone bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty. The approval is for u...
  • RoundupsRoundups

    FDA Approvals Roundup: Kloxxado, Farxiga, Ferriprox

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Higher-dose Kloxxado nasal spray cleared for countering opioid overdose Hikma’s Kloxxado (naloxone hydrochloride nasal spray) has been approved for treating opioid overdose. Its indicated dose of 8 mg is notably higher than the previously approved doses of 2 and 4 mg for other naloxone nasal spray products.   Kloxxado was approved thro...
  • Feature ArticlesFeature Articles

    April’s Regulatory Focus: Professional and career development

    Feature articles during April focused on the regulatory profession and specifically, professional development and career advancement. Included were articles on the mid-career transition from research scientist to regulatory professional, continuous professional development and the value of graduate-level qualifications, and findings from two surveys on different aspects of the profession. Other articles examined communication – one on persuasive skills, another on dissemin...
  • RoundupsRoundups

    FDA Approvals Roundup: Jemperli and Zynlonta

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Jemperli nabs approval for advanced endometrial cancer with specific biomarker GlaxoSmithKline’s Jemperli (dostarlimab-gxly) has been granted accelerated approval for treating adults with recurrent or advanced endometrial cancer whose tumors are mismatch repair deficient (dMMR) and in whom disease has progressed despite previous treatmen...
  • RoundupsRoundups

    FDA Approvals Roundup: Nextstellis, Ragwitek, Opdivo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Nextstellis cleared as first new oral contraceptive in over 50 years Mayne’s Nextstellis (drospirenone and estetrol [E4] tablet) has been approved for the prevention of pregnancy in individuals of reproductive potential.   Nextstellis was approved based on efficacy findings from the year-long phase 3, prospective, multicenter, open-label, s...
  • RoundupsRoundups

    FDA Approvals Roundup: Trodelvy and Xolair

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Trodelvy approved for advanced triple-negative breast and urothelial cancers Immunomedics’ Trodelvy (sacituzumab govitecan-hziy) has received regular approval for treating unresectable locally advanced or metastatic triple-negative breast cancer ( mTNBC) and accelerated approval for locally advanced or metastatic urothelial cancer ( mUC ), both for ...