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With this approval, atezolizumab plus nab-paclitaxel is the first cancer immunotherapy regimen to be approved for breast cancer.

Atezolizumab (Tecentriq) plus chemotherapy is approved under the FDA’s Accelerated Approval Program, which allows conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening disease or condition.

Dupilumab (Dupixent, Regeneron and Sanofi) would be the first FDA-approved biologic for the treatment of severe chronic rhinosinusitis with nasal polyps.

Dupilumab (Dupixent, Regeneron and Sanofi) would be the first FDA-approved biologic for the treatment of severe chronic rhinosinusitis with nasal polyps.

Top news of the day from across the health care industry.

Top news of the week from Specialty Pharmacy Times.

If approved, rilpivirine plus cabotegravir would be the first monthly dosing option for adult patients with HIV.

Recently approved by the US Food and Drug Administration (FDA), the Biktarvyregimen is indicated for the treatment of adults with HIV-1 who have no history of antiretroviral therapy.

An individual treated for HIV is believed to be in long-term remission, according to experts in the United Kingdom. 'The London Patient’ is only the second documented case of sustained remission for HIV infection.

Venetoclax (Venclexta) plus obinutuzumab (Gazyva) is being developed for patients with previously-untreated chronic lymphocytic leukemia and co-existing medical conditions.

The supplemental new drug application for venetoclax in combination with obinutuzumab is being reviewed under the FDA’s Real-Time Oncology Review pilot program for patients with previously-untreated chronic lymphocytic leukemia.

Study focuses on the importance of distinguishing whether sugar-sweetened beverages heightened disability in patients with multiple sclerosis.

Top news of the day from across the health care industry.

The prevalence of multiple sclerosis in the United States has steadily grown over the past 5 years to nearly 1 million people.

The awards will be presented at the ASHP’s Summer Meetings and the 54th Midyear Clinical Meeting.

The sNDA is based on results from the phase 3 CAPSTONE-2 study of a single dose of Xofluza compared with placebo or oseltamivir 75 mg, twice daily for 5 days, in people 12 years of age or older who are at high risk of complications from the flu.

Smaller entrepreneurial pharmacy owners are proactively pursuing the dispensing of specialty medications.

Officials with the FDA have approved esketamine CIII nasal spray (Spravato, Janssen Pharmaceutical Companies of Johnson & Johnson) for use in conjunction with an oral antidepressant in adults with treatment-resistant depression.

Ublituximab may provide a clinical benefit for patients with multiple sclerosis via lower doses and faster infusion times than current therapies.

Top news of the day from across the health care industry.

The Priority Review is set to fast-track an application of a drug that may potentially represent a significant advancement in treatment for a serious condition.

Approximately 1.7 million insured US patients are burdened with moderate to severe plaque psoriasis.

Once Spravato is determined as an appropriate treatment option, in accordance with the REMS, the patient will be treated at a certified treatment center that is trained to administer the medicine and address patient needs.

FDA Commissioner Scott Gottlieb, MD, cited that he was “missing” his family as the reason for his impending departure.

The CDC urges health care providers to implement its recommendations and to regularly review their facility infection data, among other intervention methods.

Expert witnesses all testified that there is no evidence to support the belief by some parents that vaccines cause autism.

The CDC urges health care providers to implement its recommendations and to regularly review their facility infection data, among other intervention methods.

If approved, fedratinib would be the second FDA-approved treatment for myelofibrosis.