Regulatory

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.

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.

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.

In this Pharmaceutical Executive Video Interview, Peter Ax, Founder & CEO of UpScriptHealth, explores how tariffs could affect the availability and accessibility of specific medications, particularly for patients relying on direct-to-patient telehealth.

In the SWIFT and ANCHOR trials, depemokimab demonstrated statistically significant reductions in nasal polyp size, obstruction, and asthma exacerbations compared to placebo.

In this part of his Pharmaceutical Executive Video Interview, Peter Ax, Founder & CEO of UpScriptHealth, identifies strategies that pharmaceutical companies and digital health platforms can employ to navigate a potential drop in demand due to tariff-induced increased costs.

In this Pharmaceutical Executive video interview, Jen Butler, Chief Commercial Officer for Pleio, the role pharma should be playing in helping to ensure patients have access to health insights they can trust.

Results from a Phase III study in pediatric patients demonstrated that Odactra reduced the total combined rhinitis score by 22% compared to placebo.

In this Pharmaceutical Executive Video Interview, Peter Ax, Founder & CEO of UpScriptHealth, addresses how tariffs will affect pharmaceutical costs and which drug categories will be most affected.

In this Pharmaceutical Executive video interview, Jen Butler, Chief Commercial Officer for Pleio, shares some best practices on finding trustworthy and verified information about a new prescription or medical device.

The application leverages existing clinical data for Uzedy along with prior FDA findings on the safety of Udezy in patients with bipolar I disorder.