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Astellas said it will work closely with the FDA and a third-party manufacturer to develop a timeline that will quickly resolve feedback from the complete response letter to a Biologics License Application for zolbetuximab.

Tivdak (tisotumab vedotin-tftv), an antibody drug conjugate, was granted accelerated approval by the FDA in September 2021 for patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.

Rinatabart sesutecan (Rina-S; PRO1184) showed encouraging antitumor activity and tolerability in patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

Analysis reveals how QbTest is used to measure the effectiveness of ADHD drugs.

Scemblix (asciminib) was approved by the FDA in October 2021 for patients with chronic phase chronic myeloid leukemia previously administered two or more tyrosine kinase inhibitors and for adults with chronic phase chronic myeloid leukemia with the T315I mutation.

In the midst of being approved for commercial manufacturing of Pluvict, the 70,000 square-foot site was built specifically to accommodate RLT production.

Trials will evaluate four novel agents for cancers that include essential thrombocythemia, chronic lymphocytic leukemia, small lymphocytic lymphoma, non-small cell lung cancer, endometrial carcinoma, and metastatic castration-resistant prostate cancer.

US biosimilars market projected to grow from less than $10 billion in 2022 to more than $100 billion by 2029.

LillyDirect will facilitate access to medications by connecting patients with independent telehealth providers, bypassing the need to obtain a prescription from a physician and then going to a pharmacy to fill it.

Cretostimogene grenadenorepvec is a novel, intravesically delivered oncolytic immunotherapy under evaluation for the treatment of patients with high-risk Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without Ta or T1 tumors.

Electronic health record messaging network found to improve communication and lead to better medication adherence.

Provider’s Pithampur facility is recognized for its use of Industry 4.0 technology.

Study examines the parallels between doctorate students and the US population.

Aglatimagene besadenovec and prodrug plus chemoradiation prior to surgery was found to produce an extended and sustained survival benefit among patients with borderline resectable pancreatic ductal adenocarcinoma.

The latest move expands the company’s storage capacity and cold chain capabilities.

Agreement includes novel cell therapy for hematology that has the opportunity to bring a potential best-in-class treatment to patients with blood cancers.

Teams need to keep close track of ingredients, processing parameters, and material performance so that they can use their R&D data to decide exactly which materials to make next.

Popular works in the category explore 340B guidelines, ‘smart pharma’ capabilities, and commercialization trends.

Over the past year, Pharma Commerce’s digital coverage featured a variety of subject matters, ranging from how to calculate 340B prices, to the future of pharmacy.

The most popular pieces pertaining to the supply chain featured ADMs, vaccine supply chains, and wholesalers.

Items in this sector ranged touched on topics such as pharma shipping, container technology, and sustainability.

This year’s PC Podcast episodes ranged in topic, from DSCSA compliance to pharmacovigilance.

A panel designs a conceptual framework in an effort to limit partiality.

If the FDA approves the sBLA for Xolair, it would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure.

If the FDA approves garadacimab, it would be the first approved hereditary angioedema therapy that targets activated FXIIa.

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

Merck’s Biologics License Application for V116, a 21-valent pneumococcal conjugate vaccine, was given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024.

FDA expands indication for LEO Pharma’s Adbry (tralokinumab-ldrm) to include patients 12 to 17 years of age with moderate-to-severe atopic dermatitis.

Moderna previously filed marketing authorization submissions for mRNA-1345 for the prevention of RSV-associated lower respiratory tract disease and acute respiratory disease in adults aged 60 years and older.

Jemperli has shown potential both as a monotherapy and in combination with standard of care and future novel cancer therapies, particularly in patients with currently limited treatment options.