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FDA to expedite review of zotatifin plus Faslodex (fulvestrant) and Verzenio (abemaciclib) as a second- or third-line treatment for patients with estrogen receptor–positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer whose disease progressed after treatment with endocrine therapy and a CDK4/6 inhibitor.

The use of real-world evidence can prevent pharma companies from performing studies based on flawed data.

Blenrep significantly extended the time to disease progression or death against existing care methods as a second-line treatment for relapsed or refractory multiple myeloma.

JAMA study investigates whether consuming energy drinks was associated with adverse pregnancy outcomes and whether caffeine consumption affects fetal-growth restriction.

AbbVie acquiring all outstanding shares of ImmunoGen, Inc. for $31.26 per share, valuing the company at a total equity value of approximately $10.1 billion.

Supplemental new drug application for roflumilast cream 0.15% to treat atopic dermatitis in patients 6 years of age and older was assigned a Prescription Drug User Fee Act target action date of July 07, 2024.

Drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare but serious and potentially fatal reaction linked to use of antiseizure medications.

KarXT (xanomeline-trospium) is currently in development to treat schizophrenia and psychosis related to Alzheimer disease.

Vivos becomes the first company to bring to market an alternative to continuous positive airway pressure (CPAP) or surgical neurostimulation implants for patients with severe OSA.

The FDA will investigate all currently approved CAR T-cell treatments, as well as BCMA-directed and CD19-directed genetically modified autologous CAR T-cell therapies, for the risk of secondary T-cell malignancies.

Law aims to mitigate ongoing global drug shortages.

Researchers highlight steps to be taken in the European Union to manage the challenge of ongoing drug shortages.

The launch of the Elecsys HBeAg quant immunoassay adds to Roche's viral hepatitis testing portfolio.

Ogsiveo is the first and only drug approved by the FDA to treat desmoid tumors.

For manufacturers who participate in the 340B program, costs have increased because they are required to provide steep discounts on their drugs at levels far below private market prices.

Trial results expected to accelerate the potential of Dupixent to become the first FDA-approved treatment for chronic obstructive pulmonary disease.

AbbVie and Genmab will share commercial responsibilities in the United States and Japan for epcoritamab-bysp (Epkinly), whereas AbbVie will be responsible for further global commercialization.

Manufacturer states that novel drug is the most advanced multi-food oral immunotherapy drug candidate currently in development.

Study aims to find ways industry gets involved in the most influential clinical trials, and how transparent these trials are.

IQVIA report explores why these shortages are increasing, and how they can be mitigated.

Medication focuses on the acute treatment of migraines.

Study emphasizes role in bridging research and development and commercial/marketing functions.

Heliyon study evaluates online information, labeling accuracy, and quantitative analysis of high peroxide content gels.

Enzalutamide (Xtandi) from Astellas Pharma Inc. and Pfizer Inc. gets FDA approval to treat nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

Merck's pembrolizumab (Keytruda) plus fluoropyrimidine- and platinum-containing chemotherapy approved for the first-line treatment of patients with locally advanced unresectable or metastatic, HER2-negative gastric/GEJ adenocarcinoma.

Capivasertib (Truqap) plus fulvestrant (Faslodex) is a first-of-its-kind combination for HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1 or PTEN biomarker alterations.

JAMA study argues that addressing social determinants of health is crucial to narrowing life expectancy gaps between high- and low-income countries.

An overview of what biopharma C-Suites and their boards should consider when engaging with government and business leaders from China, the world’s second largest economy.