FDA

Findings from ADVANCE-CIDP 1 and ADVANCE-CIDP 3 trials lead to FDA approval for HyQvia as a maintenance therapy to protect against relapse of neuromuscular disability and impairment in adult patients with chronic inflammatory demyelinating polyneuropathy.

Casgevy is a non-viral, ex vivo CRISPR/Cas9 gene-edited cell therapy that was also recently approved for sickle cell disease.

The 39th overall approval for Keytruda was based on data from the Phase III KEYNOTE-A18 trial in patients with FIGO 2014 stage III to IVA cervical cancer.

An open-label, randomized, dose-optimization Phase II trial (NCT06173037) is assessing the antibody-drug conjugate RC88 to determine the optimal dosage, efficacy, and safety in patients with platinum-resistant ovarian cancer.

The efficacy of Axon Therapy was shown in a randomized controlled trial that demonstrated significant efficacy in reducing pain and numbness associated with painful diabetic neuropathy.

SLS009 is a CDK9 inhibitor under evaluation in an ongoing Phase I/II study in patients with relapsed or refractory acute myeloid leukemia.

Shorla Oncology’s New Drug Application for SH-105 for breast and ovarian cancers was given a Prescription Drug User Fee Act action date of June 29, 2024.

The FDA's complete response letter was not related to clinical trial data for efficacy or safety for zolbetuximab for the treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction.

Findings from the Phase III innovaTV 301 trial showed a favorable benefit/risk profile for Tivdak (tisotumab vedotin-tftv), as well as improved overall survival for patients with recurrent and metastatic cervical cancer who have limited treatment options.

Rinatabart sesutecan (Rina-S; PRO1184) is a novel folate receptor alpha (FRα)–targeted antibody-drug conjugate for patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

Data from the Phase III ZIRCON trial show the positron emission tomography imaging agent 89Zr-DFO-girentuximab was more effective than traditional PET/CT imaging in identifying malignant renal cell carcinoma lesions.

Results from the Phase III BOND-003 trial demonstrated that treatment with CG Oncology Inc’s cretostimogene grenadenorepvec (CG0070) provided clinical benefit in complete responses with acceptable tolerability for the treatment of patients with high-risk Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle invasive bladder cancer.

EUA submission based on positive initial findings from the pivotal Phase III CANOPY clinical trial for VYD222, a broadly neutralizing, half-life extended monoclonal antibody developed specifically to prevent COVID-19 in immunocompromised adults and adolescents.

A Phase II trial (NCT02446093) is currently investigating neoadjuvant therapy with aglatimagene besadenovec plus valacyclovir with standard chemoradiation and surgery for the treatment of patients with borderline resectable or locally advanced nonmetastatic pancreatic ductal adenocarcinoma.

Results from the Phase III OUtMATCH trial show Xolair significantly increased the amount of peanuts, milk, egg, and cashew that patients with food allergies could consume before triggering an allergic reaction.

Garadacimab was previously granted orphan drug designation for patients with hereditary angioedema by both the FDA and EMA.

Filsuvez is indicated to treat wounds associated with junctional epidermolysis bullosa and dystrophic epidermolysis bullosa in patients aged 6 months and older.

If approved, Merck's V116 would be the first pneumococcal conjugate vaccine specifically designed to address the serotypes that cause most adult invasive pneumococcal disease.

Adbry is the first and only biologic FDA-approved for patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or for whom those therapies are not advisable.

Zoryve (roflumilast) topical foam, 0.3% is a highly potent and selective phosphodiesterase type 4 inhibitor in development to treat inflammatory dermatoses.

Results from the EV-302/KN-A39 clinical trial found that Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) produced a median overall survival of 31.5 months compared to 16.1 months with platinum-based chemotherapy.

The Phase III SEACRAFT-2 trial will analyze the clinical efficacy of naporafenib compared with physician’s choice of single-agent dacarbazine, temozolomide, or trametinib among patients with NRAS-mutated metastatic melanoma who received prior treatment with an immunotherapy.

Trial findings show Welireg lowered the risk of disease progression or death compared to Afinitor in patients with advanced renal cell carcinoma whose disease progressed following treatment with a PD-1 or PD-L1 inhibitor and a TKI.

This is the first FDA approval of a therapy indicated to decrease the risk of relapse in pediatric patients with high-risk neuroblastoma.

MAPS Public Benefit Corporation has submitted a new drug application to the FDA for MDMA (midomafetamine capsules) for use with psychological intervention to treat post-traumatic stress disorder.

Phase II open-label, non-comparative, multicenter clinical trial shows Cresemba is effective in pediatric patients as young as 1 year of age with invasive aspergillosis and invasive mucormycotic.

Casgevy, which was approved along with Lyfgenia, is the first approval for a novel genome editing technology for sickle cell disease, which represents a significant advancement in gene therapy.

Clinical trials demonstrated superiority of Fabhalta to anti-C5s in hemoglobin improvement in the absence of transfusions and transfusion avoidance rate, showing clinically meaningful hemoglobin-level increases without the need for blood transfusions in patients with paroxysmal nocturnal hemoglobinuria.

Johnson & Johnson’s TAR-200 is currently in clinical trials for patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer who are ineligible for or elected not to receive bladder removal surgery.

Opdivo in combination with cisplatin-based chemotherapy shows durable responses and improved survival for patients with metastatic urothelial carcinoma.