• RoundupsRoundups

    FDA Approvals Roundup: Qelbree, Sarclisa, Tyvaso

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Qelbree okayed as nonstimulant therapy option for children with ADHD Supernus’s Qelbree (viloxazine extended-release capsules) has been approved for the treatment of  attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years.   The serotonin norepinephrine modulating agent provides a nonstimulant alternat...
  • Feature ArticlesFeature Articles

    March's Regulatory Focus: Regulatory intelligence

    Feature articles during March focused on regulatory intelligence (RI), including first-hand accounts of setting up a dedicated process for RI monitoring and developing an in-house RI database, as well as an examination of the implications of the US Food and Drug Administration’s (FDA’s) new integrated review template for RI. Also included were articles on the importance a global unique device identification (UDI) system, the FDA’s Bad Ad program, and the importance of writ...
  • RoundupsRoundups

    FDA Approvals Roundup: Abecma, Vyxeos, Myrbetriq

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Abecma cleared as first cell-based gene therapy for multiple myeloma in adults Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) has been approved for treating relapsed or refractory multiple myeloma in previously treated adults, making it the first FDA-sanctioned cell-based gene therapy for this condition.   Abecma is a B-cell maturati...
  • RoundupsRoundups

    FDA Approvals Roundup: Ponvory, Zegalogue, Exparel

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Ponvory okayed for use in adults with relapsing multiple sclerosis Janssen’s Ponvory (ponesimod) has been approved as a once-daily oral therapy for adults with relapsing multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.   Approval of Ponvory was based on fi...
  • RoundupsRoundups

    FDA Approvals Roundup: Fotivda, Kimyrsa

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Fotivda nabs approval for pretreated, advanced renal cell carcinoma Aveo’s Fotivda (tivozanib ) has been approved for treating relapsed or refractory advanced renal cell carcinoma (RCC) in adults who have received two or more systemic therapies.   Approval for the kinase inhibitor was supported by efficacy findings from the randomized, open-...
  • RF Quarterly

    RF Quarterly, March 2021: Global clinical trials

    Welcome to the inaugural issue of RF Quarterly featuring original, thematically developed content by regulatory experts addressing key areas and emerging issues in the global regulatory landscape. RF Quarterly is a member-exclusive addition to the regular monthly  Regulatory Focus  feature articles and replaces the former quarterly article series. The theme for this issue is Global Clinical Trials.   Clinical trials are an essential component of pharmaceutical re...
  • RoundupsRoundups

    FDA Approvals Roundup: Azstarys, Lorbrena, Yescarta

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Azstarys approved as once-daily treatment for ADHD in children Corium’s Azstarys (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH] capsule) has been approved in three dosage strengths for treating attention deficit hyperactivity disorder (ADHD) symptoms in patients aged 6 years or older.   The approval was supported by findings fro...
  • RoundupsRoundups

    FDA Approvals Roundup: Nulibry, Amondys 45, Pepaxto

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Nulibry okayed to cut mortality risk in babies with rare genetic disorder Origin Biosciences’ Nulibry (fosdenopterin injection) has been approved for reducing the risk of death from molybdenum cofactor deficiency (MoCD) type A, a rare, genetic metabolic disorder marked by severe seizures. The condition presents soon after birth and most patients...
  • Feature ArticlesFeature Articles

    February's Regulatory Focus: Global and regional harmonization and alignment

    Feature articles during February included a range of topics focused on harmonization and alignment across global and regional regulatory entities, including electronic submissions through the European Medicines Agency (EMA), tools for updating the EU In Vitro Diagnostic Regulation (EU IVDR) template, China’s new PAC regulation, Project Orbis and improving patients access to new therapies, as well as a report on medtech companies’ preparation for EU Medical Device Regulatio...
  • RoundupsRoundups

    FDA Approvals Roundup: Libtayo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Libtayo gets extended indication for NSCLC with high PD-L1 expression Regeneron’s Libtayo (cemiplimab-rwlc injection) has been approved as a first-line therapy for advanced non‒small cell lung cancer (NSCLC) in patients whose tumors have high programmed death-ligand 1 expression established by an FDA-approved test. The patients must have eithe...
  • RoundupsRoundups

    FDA Approvals Roundup: Evkeeza, Cosela, Entresto

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Evkeeza gets thumbs up as add-on therapy for inherited severely high cholesterol Regeneron’s Evkeeza (evinacumab-dgnb injection) has been approved as an add-on therapy for homozygous familial hypercholesterolemia (HoFH) in patients aged 12 years or older.   HoFH is a genetic condition that causes life-threatening, severely high levels of low...
  • RoundupsRoundups

    FDA Approvals Roundup: Breyanzi, Ukoniq, Libtayo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Breyanzi okayed for relapsed/refractory large B-cell lymphoma Juno’s Breyanzi (lisocabtagene maraleucel) has been approved for previously treated adults with relapsed or refractory large B-cell lymphoma ( LBCL ), including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal LBCL, and follicular ...