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  • RoundupsRoundups

    FDA Approvals Roundup: Rukobia, Byfavo, Inqovi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Rukobia gets the green light for hard-to-treat HIV ViiV Healthcare’s Rukobia (fostemsavir) has been approved for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant infection whose current antiretroviral regimen is ineffective because of resistance, intolerance, or safety concerns.   The drug, a ...
  • RoundupsRoundups

    FDA Approvals Roundup: Fintepla, Dojolvi, Phesgo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Fintepla gets the go-ahead for Dravet syndrome Zogenix’s Fintepla (fenfluramine) has been approved for the treatment of seizures associated with Dravet syndrome in patients aged 2 years or older. The syndrome is a rare, life-threatening form of epilepsy.   The approval was based on findings from two clinical studies in 202 participants aged ...
  • Feature ArticlesFeature Articles

    Regulatory Focus, June issue: Nutrition in health and disease management

    This month marks the fifth anniversary of the annual series on nutrition in health and disease management, initiated in 2016 by Manfred Ruthsatz , PhD, RAC, FRAPS (executive director, Nutrition+HealthCARE, Switzerland). Ruthsatz has led all five series to date, this year, together with co-lead, Andrea Wong , PhD (SVP, scientific and regulatory affairs, Council for Responsible Nutrition, Washington DC). They have coordinated authors and reviewers who are global leaders in...
  • RoundupsRoundups

    FDA Approvals Roundup: Tazverik, Crysvita, Xpovio

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Tazverik extended as therapy for mutated follicular lymphoma Epizyme’s Tazverik (tazemetostat) has been granted accelerated approval for treating adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation, as detected by an FDA-approved companion diagnostic, the cobas EZH2 Mutation Test (Roche...
  • Regulatory NewsRegulatory News

    FDA sends first warning letters for fraudulent marketing of antibody tests

    The US Food and Drug Administration this week issued its first set of warning letters for marketing adulterated or misbranded COVID-19 antibody tests.   The letters, sent to Medakit Ltd. of Hong Kong,  Antibodiescheck.com of United Arab Emirates, and Sonrisa Family Dental dba www.mycovidtest19.com of Chicago, cited a range of violations. These included offering test kits for sale in the US directly to consumers for at-home use without marketing approval, cleara...
  • RoundupsRoundups

    FDA Approvals Roundup: Zepzelca, Ilaris, Lyumjev

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Zepzelca handed accelerated approval for metastatic SCLC in adults Jazz Pharmaceuticals and PharmaMar’s Zepzelca (lurbinectedin) has been granted accelerated approval for adult patients with metastatic small cell lung cancer (SCLC) whose disease has progressed during or after platinum-based chemotherapy.   The indication was approved based o...
  • RoundupsRoundups

    FDA Approvals Roundup: Recarbrio

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   Recarbrio indication extended to pneumonia FDA has approved Merck’s Recarbrio (imipenem-cilastatin and relebactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial (HABP/VABP) pneumonia in patients aged 18 years or older.   The antibiotic was initially approved in 2019 for complicated urinary tract and intra-abdom...
  • Regulatory NewsRegulatory News

    FDA names Farley director of the Office of Infectious Diseases

    John Farley has been appointed director of the Office of Infectious Diseases (OID) in the Center for Drug Evaluation and Research’s Office of New Drugs (OND). He had been acting director of OID since Edward Cox left the agency in August 2019 to join Regeneron.   (RELATED: As the race for a permanent FDA commissioner picks up, agency turnover continues , Regulatory Focus 4 September 2019).   As acting director, Farley has presided over the OID’s response to the...
  • RoundupsRoundups

    FDA Approvals Roundup: Tauvid, Oriahnn, Sirturo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Tauvid nabs approval as first drug to aid imaging of tau pathology FDA has approved Avid Radiopharmaceuticals’ radioactive diagnostic agent Tauvid (flortaucipir F18 injection) as the first drug to image tau pathology, a distinctive characteristic of Alzheimer’s disease in the brain.   The drug is indicated for intravenous administration bef...
  • Feature ArticlesFeature Articles

    Risk management, drug shortages and the EU portal for clinical trials

    Feature articles during May focused on risk management and mitigation in dealing with contractors and vendors and included articles on best practices in good vendor management, use of risk management to support outsourcing activities, testing in-house versus outsourcing, and outsourcing in regulatory operations. Also included were in-depth examinations of challenges and opportunities in “bespoke” therapies, a critical appraisal of drug shortages in Germany and an update on...
  • Regulatory NewsRegulatory News

    New approvals and indication from FDA: Alunbrig, VESIcare LC, Kynmobi and more

    This is the first in a series of weekly roundups of new drug approvals and indications from the US Food and Drug Administration (FDA).   Alunbrig gets new indication as first-line therapy for ALK-positive metastatic NSCLC On 22 May, FDA approved a new indication for Takeda’s Alunbrig (brigatinib) as a first-line treatment for adults with anaplastic lymphoma kinase‒positive metastatic non‒small cell lung cancer (NSCLC). The agency also approved a companion diagnost...
  • Regulatory NewsRegulatory News

    Notable approvals: FDA okays Tabrecta, adds indication for Farxiga

    The US Food and Drug Administration (FDA) on Wednesday granted accelerated approval to Novartis Pharmaceuticals’ Tabrecta (capmatinib) as the first targeted therapy for adults with metastatic non-small cell lung cancer (NSCLC) who have mutations that drive mesenchymal-epithelial transition (MET) exon 14 skipping. The drug inhibits MET tyrosine kinase, an enzyme associated with cancer cell growth and metastasis.   The agency also approved FoundationOne CDx assay (F1CD...