As reported on FiercePharma, the U.S. Food and Drug Administration (FDA) has selected seven pharmaceutical and biotechnology companies to participate in its newly established PreCheck Pilot Program, an initiative aimed…
As reported on Pharmaceutical Technology, the US Food and Drug Administration (FDA) has approved a new adjuvant treatment option for adults with clear cell renal cell carcinoma (ccRCC) at elevated…
As reported on MedCity News, the U.S. Food and Drug Administration (FDA) has introduced a new regulatory pathway that could reshape how treatments are developed for rare diseases. Known as…
As shared in a recent press release, the U.S. Food and Drug Administration (FDA) has granted accelerated approval to teplizumab (Tzield) for a new pediatric indication, marking a major development…
As reported on MedCity News, the U.S. Food and Drug Administration (FDA) has issued draft guidance encouraging the thoughtful use of Bayesian statistical approaches in clinical trials, marking a notable…
In a notable update for dermatologic and consumer health, the U.S. Food and Drug Administration (FDA) released a press statement disclosing their authorization of the use of bemotrizinol as an…
As reported on Becker's Hospital Review, the U.S. Food and Drug Administration’s launch of a real-time clinical trial model marks a notable shift in how oncology research is conducted and…
As reported in BioPharmaDive, the U.S. Food and Drug Administration (FDA) has postponed its decision on camizestrant, an experimental oral therapy for breast cancer being developed by AstraZeneca, following a…
As reported on FiercePharma, Cingulate Therapeutics has encountered a regulatory setback in its effort to bring its lead attention-deficit/hyperactivity disorder (ADHD) therapy to market, after the U.S. Food and Drug…
According to a recent report on MedTechDive, Guardant Health has received U.S. Food and Drug Administration (FDA) approval for an updated version of its liquid biopsy assay, marking a significant…
As reported on BioSpace, the U.S. Food and Drug Administration (FDA) has approved Partner Therapeutics’ bispecific antibody Bizengri for adults with cholangiocarcinoma harboring an NRG1 gene fusion, marking a significant…
As reported on FierceBioTech, Gilead Sciences has closed one of its midstage clinical studies evaluating an experimental HIV regimen, following ongoing safety concerns that prompted U.S. regulators to intervene last…
On February 23, 2026, FDA issued a Draft Guidance document, called “Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological…
As reported on PharmaBiz, the US Food and Drug Administration (FDA) has approved Novo Nordisk’s higher‑dose formulation of semaglutide, Wegovy HD (7.2 mg once weekly), for chronic weight management. The…
As reported on PharmaBiz, the US Food and Drug Administration has broadened the approved use of GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, to include adults aged 18 to 49…
As reported by FiercePharma, the U.S. Food and Drug Administration has approved the first fully independent generic version of GlaxoSmithKline’s widely used asthma inhaler, Flovent, marking a significant shift in…
As reported on FierceBioTech, the U.S. Food and Drug Administration has released its complete response letter (CRL) detailing why it declined to approve Regenxbio’s experimental gene therapy, RGX‑121, for Hunter…
The U.S. Food and Drug Administration has agreed to review Otsuka Pharmaceutical’s application for centanafadine, a new extended‑release therapy under investigation for attention‑deficit hyperactivity disorder (ADHD). The agency has granted…
The U.S. Food and Drug Administration (FDA) has approved Yartemlea (narsoplimab‑wuug), marking the first authorized therapy for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA) in adults and children aged 2…
As reported on PharmaBiz, Amneal Pharmaceuticals, in collaboration with mAbxience, has received U.S. Food and Drug Administration (FDA) approval for two denosumab biosimilars: Boncresa (referencing Prolia) and Oziltus (referencing Xgeva).…
In a recent statement, the U.S. Food and Drug Administration (FDA) has authorized regular approval to rucaparib (Rubraca) for adults with metastatic castration-resistant prostate cancer (mCRPC) harboring deleterious BRCA mutations—either…
As reported by Healio, the U.S. Food and Drug Administration (FDA) has officially qualified AIM-MASH AI Assist, marking a milestone as the first artificial intelligence tool cleared to support drug…
In a recent statement, The U.S. Food and Drug Administration (FDA) has introduced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot, a groundbreaking initiative aimed at expanding access to digital health…
The U.S. Food and Drug Administration (FDA) has approved Koselugo (selumetinib), an oral MEK inhibitor developed by Alexion, AstraZeneca Rare Disease, for adults with neurofibromatosis type 1 (NF1) who have…
Denali Therapeutics (Nasdaq: DNLI) announced that the U.S. Food and Drug Administration (FDA) has extended the review period for its Biologics License Application (BLA) for tividenofusp alfa, an investigational therapy…
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