Regulatory

Approval of Opdivo plus Yervoy combination was based on results from the Phase III CheckMate-9DW trial, which demonstrated significantly improved overall survival and overall response rate in patients with unresectable or metastatic hepatocellular carcinoma.

Full approval of Vitrakvi was based on results from three clinical trials in patients with unresectable or metastatic NTRK fusion-positive solid tumors.

As the physical products we use evolve to become increasingly complex, traditional products liability frameworks may not always fit to provide remedies for harm that can result from using novel product types.

Approval of the Opdivo plus Yervoy combination regimen was based on results from the Phase III CheckMate-8HW trial, which was the largest immunotherapy study in patients with previously untreated, unresectable, or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

Brimochol PF, a combination of brimonidine and carbachol, was found to enhance depth of focus and visual acuity in clinical trials among patients with presbyopia.

The survey also suggests that Medicaid is broadly popular amongst all Americans, regardless of political affiliation.

Results from Phase II studies demonstrated that rilzabrutinib showed clinically meaningful outcomes in patients with warm autoimmune hemolytic anemia and IgG4-related disease.

Results from the Phase III SPACE trial show that Ajovy significantly reduced monthly migraines in pediatric patients between six and 17 years of age.

Eli Lilly CEO David Ricks to the BBC: “It feels like it'll be hard to come back from here."

BIIB080 marks the first antisense oligonucleotide targeting tau to enter clinical development for the treatment of Alzheimer disease.

Qfitlia is the first FDA-approved antithrombin-lowering therapy indicated for routine prophylaxis to prevent or reduce bleeding episodes in patients over 12 years of age with hemophilia A or B.

Approval of Imfinzi marks the first and only perioperative immunotherapy indicated for muscle-invasive bladder cancer.

As part of the Fast Track designation, Sanofi is set to launch a Phase I/II trial to evaluate the immunogenicity and safety of its novel mRNA vaccine in preventing chlamydia.

Approval of Vykat XR marks the first treatment indicated for hyperphagia in patients with Prader-Willi syndrome.

Blujepa marks the first new oral antibiotic to gain FDA approval for uncomplicated urinary tract infections in nearly 30 years.

Fanhalta marks the first and only treatment for C3 glomerulopathy to gain FDA approval.

The Project Farma president discusses various ways the tariffs could impact the industry and how businesses can prepare or react.

A look at the current landscape and how young companies can set the stage for product launch.

Dr. Hernan Bazan, CEO of South Rampart Pharma, discusses his company’s current pipeline.

Fred Aslan, MD, CEO, Artiva Biotherapeutics, explains what the FDA Fast Track designation for AlloNK in autoimmune diseases means for the acceleration of its development and potential approval of the therapy.

What biopharma companies need to know about this evolving regulatory pathway.

Omlyclo, a biosimilar to Xolair, is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E-mediated food allergies, and chronic spontaneous urticaria.

Jonathon Whitton, AuD, PhD, VP, auditory global program head, Regeneron, discusses how key regulatory designations, such as the FDA's Regenerative Medicine Advanced Therapy designation, facilitate accelerated development and commercialization of DB-OTO through increased collaboration with regulators.

Dr. Hernan Bazan, CEO of South Rampart Pharma, discusses his company’s current pipeline.

The approval of neffy marks the first major advancement in epinephrine delivery for patients over four years of age in more than 35 years.

The recent shift in Health Economics and Outcomes Research functions across major pharmaceutical companies highlights a lack of understanding of its value.

Submission is supported by positive results from the Phase III REGENCY trial, which demonstrated that nearly half of patients with lupus nephritis who received Gazyva/Gazyvaro plus standard therapy achieved a complete renal response.

In this Pharmaceutical Executive video interview, Jen Butler, Chief Commercial Officer for Pleio, explores what kind of role regulatory agencies should play in the battle against misinformation.

New indication for Tevimbra in combination with platinum-containing chemotherapy as a first-line treatment addresses an unmet need for adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1.

Stoboclo, a biosimilar to Prolia, is indicated for postmenopausal women and men at high risk of fracture, while Osenvelt, a biosimilar to Xgeva, is indicated for preventing skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors.