Trials & Filings

Merck’s Capvaxive Approved by FDA for Additional Indication in Pediatric Pneumococcal Disease

The treatment becomes the only one indicated and studied in the U.S. for this specific patient population.

Trials & Filings

FDA Approves EBGLYSS 8-Week Dosing

Lilly’s atopic dermatitis treatment may now require as few as six maintenance injections per year.

Trials & Filings

Pfizer’s Hympavzi Gets FDA Approval for Expanded Indication

The new approval is similar, though not identical, to one granted in the EU last month.

Trials & Filings

AstraZeneca’s Imfinzi Approved by FDA for BCG-Naïve Non-Muscle-Invasive Bladder Cancer

This marks the latest indication in oncology for Imfinzi nine years after the drug’s first approval.

Trials & Filings

FDA Approves AbbVie’s DECNUPAZ for BPDCN

Approval gives adults with BPDCN a new treatment option for this rare, aggressive blood cancer.

Trials & Filings

Gilead HDV Treatment Hepcludex Gets FDA Accelerated Approval

It is the first and only treatment for adults with chronic HDV in the United States.

Trials & Filings

AstraZeneca Hypertension Treatment Baxfendy Approved by FDA

Baxfendy is a first-in-class, highly selective, potent aldosterone synthase inhibitor.

Trials & Filings

AstraZeneca, Daiichi Sankyo’s Enhertu Gets New US Approval for Two HER2-Positive Breast Cancer Indications

The FDA had granted Priority Review for one of the indications in March.

Collaborations & Alliances

FDA Approves First Simponi Biosimilars in U.S.

Accord BioPharma will be responsible for commercializing IMMGOLIS and IMMGOLIS INTRI in the U.S.

Trials & Filings

Valar Labs Gets FDA Breakthrough Device Nod for Vesta Bladder Cancer Risk Test

Vesta Bladder Risk Stratify Dx becomes the first AI-powered digital pathology prognostic test in bladder cancer to receive the designation.

Trials & Filings

BMS Gets EU Approval for Sotyktu for Treatment of Active Psoriatic Arthritis

The U.S. FDA approved the TYK2 inhibitor for the same indication in March.

Trials & Filings

Harbour BioMed’s IND for HBM7004 Cleared by FDA

A first-in-human Phase I clinical trial will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM7004 in subjects with advanced solid tumors.

Trials & Filings

Laguna Diagnostics mRNA Gene Biomarker Test Gets FDA Breakthrough Device Status

It’s a novel, blood-based test to aid differentiation of schizophrenia and bipolar I disorder.

Trials & Filings

Merck Once-Daily HIV Treatment Idvynso Approved by FDA

The single-tablet regimen of doravirine and islatravir will be available in U.S. pharmacies as soon as May 12.

Trials & Filings

FDA Approves Travere’s Filspari for Treatment of Focal Segmental Glomerulosclerosis

The drug, sparsentan, was shown to reduce proteinuria in patients with FSGS without nephrotic syndrome.