• RoundupsRoundups

    FDA Approvals Roundup: Vabysmo, Cabenuva, Vonvendi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Vabysmo approved for treating two types of macular disease Genentech’s Vabysmo ( faricimab-svoa; injection ) has been approved for treating wet age-related macular degeneration (AMD) and diabetic macular edema (DME) in adults. The bispecific antibody targets and inhibits the disease pathways in the respective conditions.   Approval of Vabysmo...
  • Regulatory NewsRegulatory News

    FDA approved more first-in-class drugs, gave more accelerated approvals in 2021

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 50 new drug therapies in 2021. While the figure is a slight decrease from 2020 , more drugs were designated as first-in-class and used the accelerated approval pathway than in previous years.   The approvals reported by CDER do not include biologics license applications (BLAs) approved by FDA’s Center for Biologics Evaluation and Research (CBER). In 2021, CBER approved...
  • Regulatory NewsRegulatory News

    Study: Few new drugs have high therapeutic value

    A new study published in The BMJ  finds that only a third of new drugs approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in the decade from 2007-2017 have high therapeutic value, according to appraisal by one of five independent organizations.   However, the analysis found that drugs approved through expedited programs – and especially EMA’s programs – were more likely to have high therapeutic value.   “Most of the incre...
  • 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 ...
  • 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...
  • Regulatory NewsRegulatory News

    Is FDA Too Lax With its Drug Approval Standards? Senior FDA Officials Discuss

    From industry to academia, commenters have argued that the US Food and Drug Administration’s (FDA) drug approval standards are becoming inappropriately low and that the required postapproval evaluations are either inadequate or left undone. But three senior FDA officials offered several counterpoints on Monday at the fifth annual Biopharma Congress in Washington, DC. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, explained that the agency ...
  • Regulatory NewsRegulatory News

    EMA and FDA Historically Agree on Just About Every New Drug Approval, but is That Slowly Changing?

    The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) concur more than 90% of the time in their decisions to approve new drugs, according to a new study from EMA and FDA officials that looked at 107 applications from 2014 to 2016. In just eight of the 107 applications, FDA initially declined to approve a new drug or biologic while EMA approved it, although in all eight of those cases, FDA ended up approving that drug or biologic. And in one case ...
  • Regulatory NewsRegulatory News

    FDA's Record Year: A Look at 2018 New Drug Approvals

    The US Food and Drug Administration (FDA) set an all-time record for new drug approvals in 2018 with 59 novel drugs and biologics approved by the agency's Center for Drug Evaluation and Research (CDER).   The number of new molecular entities (NMEs) and biologics approved by CDER surpassed the agency's previous record of 53 approvals in 1996 and is a significant jump over the 46 new drugs approved in 2017 . Those figures do not include products approved by FDA's Center...
  • Regulatory NewsRegulatory News

    CDER Report on Novel Approvals Highlights Firsts in 2017

    2017 was a year of firsts for the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), with initial approvals in at least five medical conditions and other firsts that might not end up on the final scorecard, like the first biosimilar cancer treatment or the first immediate-release opioid with abuse-deterrent properties. And though the total 46 approvals is the second-highest number of approvals by CDER ever, according to the CDER ...
  • Regulatory NewsRegulatory News

    Updated: New Drug Approvals for FDA: 2017 Hits 21-Year High

    The number of new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2017 (46 so far, though that number does not include the high-profile CAR-T and gene therapies approved this year) has now topped the all-time high of NMEs approved in any year except 1996. But the record number of approvals comes as experts, including CDER Director Janet Woodcock, have expressed reservations about tracking NME approvals like a horse race, or compari...
  • Regulatory NewsRegulatory News

    FDA Offers Two New Draft Guidances on Developing Targeted Therapies

    The US Food and Drug Administration (FDA) on Friday published two new draft guidance documents that seek to support the development of treatments that address underlying genetic mutations that often cause or contribute to diseases, and another discussing how to determine if an in vitro diagnostic (IVD) device used in a study must undergo its own FDA review, distinct from a drug study. "New drugs are being developed based solely on their ability to target these und...
  • Regulatory NewsRegulatory News

    FDA's Frey Reflects on Final Year of PDUFA V

    As the year comes to a close, Patrick Frey, senior advisor to the director of the Office of New Drugs (OND) at the Center for Drug Evaluation and Research (CDER), looked back at FDA's performance over the final year of the fifth iteration of the Prescription Drug User Fee Act (PDUFA V) and what's to come in PDUFA VI. Speaking at the FDA/CMS Summit in Washington, D.C. on Tuesday, Frey said that before PDUFA, and during the first four PDUFA programs, FDA was approving ab...