News

Supplemental Biologics License Application submission based on data from the Phase 3 KEYNOTE-A39 trial comparing Keytruda plus Padcev with chemotherapy of gemcitabine plus cisplatin or carboplatin.

FDA grants to expedite review of zotatifin plus Faslodex (fulvestrant) and Verzenio (abemaciclib) for patients with ER–positive, HER2-negative advanced or metastatic breast cancer.

Included in the FDA warning were levetiracetam, under the brand names Keppra and Keppra XR; Elepsia XR; Spritam; and clobazam, under the brand names Onfi and Sympazan.

DREAMM-7 was a Phase 3, multicenter, open-label, randomized trial analyzing the efficacy and safety of Blenrep plus bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma previously administered at least one prior line of treatment.

KRP203 (mocravimod) is intended to improve outcomes after hematopoietic stem cell transplantation for the treatment of hematologic malignancies.

Arcutis Biotherapeutics’ supplemental new drug application was supported by significant findings from a trio of Phase 3 trials, a Phase 2 dose ranging trial, and a pair of Phase 1 pharmacokinetic studies for roflumilast cream 0.15% to treat atopic dermatitis in patients 6 years of age and older.

Data from the EMERGENT clinical trial program show Karuna Therapeutics, Inc’s KarXT (xanomeline-trospium) produced statistically significant and clinically meaningful improvements in the symptoms of schizophrenia.

The clearance includes the Vivos Therapeutics, Inc's DNA oral appliance, the mRNA oral appliance, and the mmRNA oral appliance for adults with severe obstructive sleep apnea.

Patient-first trial design, based around the tenets of adaptability and personalization, has emerged as a key solution to increase diversity and improve trial outcomes for all.

The Elecsys HBeAg quant can detect the presence and quantity of the hepatitis B e antigen (HBeAg) in human serum and plasma.

Results from the Phase 3 DeFi trial (NCT03785964) showed that nirogacestat (Ogsiveo) reduced the risk of disease progression or mortality by 71% compared with placebo.

Epcoritamab-bysp (Epkinly; AbbVie and Genmab) is a T-cell engaging bispecific antibody under evaluation for the treatment of adults with follicular lymphoma that is relapsed or refractory following treatment with two or more therapies.

The FDA granted Fast Track Designation to ADP101 based on findings from the phase 1/2 Harmony trial (NCT04856865), which analyzed the safety and efficacy of the novel treatment in desensitizing patients with single or multiple food allergies.

Increased use of laboratory-developed tests emphasizes inaccuracy and need for regulatory intervention.

Study aims to find ways industry gets involved in the most influential clinical trials, and how transparent these trials are.

IQVIA report explores why these shortages are increasing, and how they can be mitigated.

Education and equitable access are key to unlocking its full potential in the present and future.

Medication focuses on the acute treatment of migraines.

Study emphasizes role in bridging research and development and commercial/marketing functions.

Increased use of fentanyl underscores immediate need for better testing methods.

First-in-class combination of capivasertib (Truqap) plus fulvestrant (Faslodex) approved for patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1 or PTEN biomarker alterations.

Astellas Pharma and Pfizer Inc's enzalutamide (Xtandi) gets FDA approval to treat nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

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.

Findings suggests implementation could save time and money, but needs to be evaluated carefully.

Patient and public involvement and engagement has been used for applied research projects, including clinical trials, but has been lacking in statistical methodology research.

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).