News

FDA to evaluate Darzalex Faspro with bortezomib, lenalidomide, and dexamethasone for induction and consolidation treatment and with lenalidomide for the maintenance treatment of adults newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant.

FDA to evaluate Padcev (enfortumab vedotin) with Merck’s Keytruda (pembrolizumab) for the first-line treatment of adults with previously untreated locally advanced or metastatic urothelial cancer.

The pharmaceutical packaging company unveils a new siliconization line at its SQLM plant in France.

New England Journal of Medicine study provides a breakdown of how hospitals—especially those that qualify for discounts under the federal 340B Drug Pricing Program—are able to make a profit off insurer pharmaceutical expenditures.

Breyanzi is a CD19-directed CAR T-cell therapy approved to treat multiple hematologic cancers.

Gammagard Liquid is now FDA-approved to treat neuromuscular disability and impairment in adults with CIDP; as a replacement treatment for primary immunodeficiency in patients aged 2 years and older; and as a maintenance treatment to improve muscle strength and disability in adults with multifocal motor neuropathy.

The latest financial commitment adds 24,000 liters of biologics drug substance-capacity to the company’s network.

SRP-5051 is a next-generation peptide phosphorodiamidate morpholino oligomer showing promise in the treatment of Duchenne Muscular Dystrophy patients with a confirmed exon 51-amenable mutation.

Cohort study aims to determine whether or not these regulatory changes in state government have helped reverse opioid mortality rates.

KEYNOTE-564 is the first Phase III adjuvant trial to show improved survival for renal cancer patients at risk of recurrence after surgery following treatment with Keytruda.

Trial data show Enhertu produced clinically meaningful and durable responses for a survival benefit in patients previously administered treatment for HER2-expressing metastatic solid tumors.

One lot of the company’s branded dextroamphetamine sulfate tablets is being removed from shelves nationwide due to a pharmacy receiving carbinoxamine maleate instead.

A non-randomized control trial investigates whether older adults with multiple chronic conditions can benefit by receiving more specialized services.

GLP-1 agonists may be an effective therapy to avoid severe liver disease in those with concurrent type 2 diabetes.

A deep dive into the complex playing field for M&A and partnering pursuits in today’s increasingly make-or-break landscape for biopharma innovation.

As providers and healthcare professionals recognize the potential of long-acting injectables to fight the opioid epidemic, many are actively transitioning from oral options to injectables.

The Identification of Medicinal Product framework seeks to establish a common language for identifying, documenting, and exchanging information about medicinal products.

Concerns regarding hypoglycemia potentially linked to a counterfeit version of Ozempic come at a time in which reports have grown regarding the improper use of GLP-1 receptor agonists for the purpose of cosmetic weight loss.

Dupixent is now the first and only treatment option for eosinophilic esophagitis in patients aged 1 and older, weighing at least 15 kg.

As technology continues to advance, investigators explore the legal protocol for how to handle AI-responsible injuries.

Zynrelef was initially approved by the FDA for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours following bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty.

Tesamorelin (Egrifta) was initially approved by the FDA in November 2010 for the treatment of lipodystrophy in patients also diagnosed with HIV.

FDA adds Boxed Warning that the osteoporosis medication increases the risk for severe hypocalcemia in patients with advanced chronic kidney disease, especially among those undergoing dialysis

Patients treated with Tremfya (guselkumab) saw major improvements in scalp psoriasis clearance, itch reduction, and patient-reported health-related quality of life.

Treatments required to have updated warnings include all FDA-approved CAR T-cell therapies and licensed BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies.

The FDA assigned Autolus Therapeutics' biologics license application for obecabtagene autoleucel with a Prescription Drug User Fee Act date of November 16, 2024.

The definitive merger agreement was reached in October 2023, with Bristol Myers Squibb acquiring Mirati for $58 per share in cash, for a total equity value of $4.8 billion.

Offerings include treatment plans for a considerable number of illnesses and conditions, company says.