FDA

Merck’s pembrolizumab (Keytruda) combined with fluoropyrimidine- and platinum-containing chemotherapy approved for the first-line treatment of patients with locally advanced unresectable or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma.

The FDA's approval of Bristol Myers Squibb’s repotrectinib (Augtyro) was based on findings from the open-label, single-arm, Phase 1/2 trial TRIDENT-1, which evaluated the safety, tolerability, pharmacokinetics, and anti-tumor activity of the drug in patients with advanced solid tumors.

The Phase 3 LOCK-IT-100 clinical trial for DefenCath was recommended for an early termination based on the demonstrated efficacy in treating catheter-related bloodstream infections in adults with kidney failure administered chronic hemodialysis.

In addition to its latest indication, PD-L1 IHC 22C3 pharmDx can help identify patients with non–small cell lung cancer, esophageal squamous cell carcinoma, cervical cancer, head and neck squamous cell carcinoma, and triple-negative breast cancer who may derive a benefit from treatment with pembrolizumab (Keytruda).

FDA expands indication for Pacira BioSciences, Inc's bupivacaine liposome injectable suspension (Exparel) as an adductor canal block and a sciatic nerve block in the popliteal fossa.

A pivotal Phase 3 trial for Ixchiq showed a 98.9% seroresponse rate at 28 days following a single immunization to prevent disease caused by chikungunya virus.

Adalimumab-bwwd (Hadlima; Samsung Bioepis Co., Ltd. and Organon & Co.) could become the third Humira biosimilar deemed interchangeable, following Cyltezo and Abrilada.

Adzynma was previously granted a FDA Rare Pediatric Disease Priority Review Voucher, as well as Priority Review, Fast Track, and Orphan designations for patients with congenital thrombotic thrombocytopenic purpura.

The FDA granted accelerated approved in May 2021 to pembrolizumab (Keytruda) plus trastuzumab (Herceptin), fluoropyrimidine, and platinum-containing chemotherapy for the treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Fruzaqla may help to provide a significant survival benefit to patients with metastatic colorectal cancer without negatively impacting quality of life.

Tirzepatide (Zepbound; Eli Lilly and Company) is as the first and only FDA-approved medication for obesity that activates GIP and GLP-1 hormone receptors.

Ongoing phase 1 dose-escalation trial of KO-2806 (FIT-001) for the treatment of patients with KRASG12C-mutated non-small cell lung cancer expected to begin dosing patients in combination with adagrasib by mid-2024.

The newly approved Alinity m high risk human papillomavirus (HPV) assay is indicated to detect HPV and for use in routine cervical cancer screening per professional medical guidelines.

The FDA placed a partial hold on a phase 1 trial for the Bruton tyrosine kinase degrader NX-2127 for the treatment of patients with relapsed/refractory B-cell malignancies.

Phathom Pharmaceuticals announced that it anticipates vonoprazan (Voquenza) to be commercially available by December 2023.

SLS009 is a novel CDK9 inhibitor under investigation for the treatment of relapsed/refractory peripheral T-cell lymphomas.

Exagamglogene autotemcel (exa-cel) has shown the potential to be a landmark therapy in preventing episodes of excruciating pain among patients with sickle cell disease.

The branded form of secukinumab is currently the only FDA-approved fully human biologic that directly inhibits interleukin-17A.

Abatacept is indicated across multiple inflammatory conditions, including for the treatment of adult patients with moderately to severely active rheumatoid arthritis, pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis, and active juvenile psoriatic arthritis.

Furmonertinib is in development for the treatment of advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations.

The FDA granted Wezlana with interchangeable designation after clinical trials found no clinically significant differences in safety and efficacy for the indicated conditions across multiple inflammatory diseases.

The approval of pembrolizumab (Keytruda; Merck) combined with gemcitabine and cisplatin for the treatment locally advanced unresectable or metastatic biliary tract cancer is the sixth sixth indication for the anti-PD-1 therapy for gastrointestinal cancers.

Exploring the implications of FDA’s renewed focus and commitment to expand the use of accelerated approval for gene therapy products.

Probe targets agency’s role in advising on drug testing and submissions.

Measures being mulled to reform the AA process and address public concerns around its risk-benefit payoff.

Quality metrics, more domestic production aim to avoid supply disruptions and drug shortages.

The US Congress approved a federal spending package that increases funding for a range of programs to advance health and medicine.

FDA emphasizes importance of inclusion in trials.

This week's much-anticipated meeting of FDA’s vaccine advisory committee will address critical issues related to the testing and approval of vaccines to prevent COVID-19 infection.

Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.