Inluriyo, an oral estrogen receptor antagonist, significantly reduced disease progression risk in ESR1-mutated metastatic breast cancer, as shown in the EMBER-3 trial. Keytruda Qlex, a subcutaneous ...
This is eight fewer than the FDA, which approved 46 novel drugs in 2025 – sneaking in two regulatory decisions during the ...
Stoboclo and Osenvelt were approved as interchangeable biosimilars for bone loss conditions, potentially reducing costs and increasing access. Darzalex Faspro was approved for high-risk smoldering ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...
The Food and Drug Administration said it will take steps to speed up the process of developing generic versions of complex biological drugs, in a bid to increase cheaper competition for expensive ...
In July 2025, a class 2 resubmission of tab-cel’s BLA was initiated by Atara Biotherapeutics, developer and sponsor of ...
Add Yahoo as a preferred source to see more of our stories on Google. Leucovorin.Photograph: Hannah Beier/Reuters (Photograph: Hannah Beier/Reuters) This week, the Trump administration announced that ...
Please provide your email address to receive an email when new articles are posted on . The FDA expanded linaclotide approval for IBS-C to include children aged 7 years and older. Linaclotide is now ...
Epioxa Provides the Ophthalmic Community and Patients with the First and Only FDA-Approved, Incision-Free, Topical Drug Therapy for Keratoconus Epioxa Represents a Novel, Groundbreaking Therapy for ...
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