Drug Discovery World

SEPTEMBER 12, 2024

Only two drugs were approved exclusively for children and young people with cancer by the European Medicines Agency (EMA) and five by the US Food and Drug Administration (FDA) from 2007 to 2022. In contrast, 14 new cancer medicines for adults received FDA approval in 2023 alone.

Research 147

Research Small Molecule FDA Approval Drugs 147

The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

Agency IQ

NOVEMBER 3, 2023

The prebiotic may either feed the probiotic that it is packaged with, or it may feed another beneficial microbe that is intended to complement the activity of the probiotic. In 2022, the FDA approved the first LBP – Rebyota (RBX2660; Ferring Pharmaceuticals) – but has yet to approve a recombinant LBP.

Therapies 40

Therapies Science FDA Production 40

The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Rozibafusp alfa (AMG 570). Olpasiran (AMG 890).

Biosimilars 52

Biosimilars Production Treatment FDA 52

Agency IQ

OCTOBER 6, 2023

Data on these novel approvals is published throughout the year by both CDER and CBER. AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. Amanda Conti, AgencyIQ Notably, the increase from FY 2022 was largely driven by biologic products.

FDA 52

FDA Biosimilars Science Production 52

Codon

APRIL 2, 2023

Read Inhalable nanoparticles, packaged with mRNA or CRISPR systems, efficiently edit lung cells. Large-scale purification of functional AAV particles packaging the full genome using short-term ultracentrifugation with a zonal rotor. Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals.

DNA 52

DNA RNA Engineering Licensing 52