The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will stop administering injections in its HVTN 505 clinical trial of an investigational HIV vaccine regimen because an independent data and safety monitoring board (DSMB) found during a scheduled interim review that the vaccine regimen did not prevent HIV infection nor reduce viral load (the amount of HIV in the blood) among vaccine recipients who became infected with HIV.

BD Rx Inc., a wholly-owned subsidiary of leading global medical technology company BD, announced today that the US Food and Drug Administration (FDA) has approved the second drug to be offered in the recently launched BD Simplist™ line of ready-to-administer prefilled generic injectables.

Nora Apothecary & Alternative Therapies today announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product.

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals USA, Inc. announced today that the FDA has approved Sucampo’s supplemental new drug application (sNDA) for AMITIZA ® (lubiprostone) (24 mcg twice daily) as the first and only oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain.

Alcon, the global leader in eye care and a division of Novartis, announces US FDA approval for Simbrinza(TM) Suspension, indicated for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. Elevated IOP is the only modifiable risk factor for glaucoma. Glaucoma is a group of eye diseases that lead to progressive damage of the optic nerve and can result in gradual, irreversible loss of vision, and eventually blindness, if left untreated. Glaucoma affects more than 2.2 million Americans and is the second-leading cause of...

Apotex had initiated a voluntary Type II recall to the retail and pharmacy level for Alysena™ 28 (lot LF01899A), on behalf of the fabricator, Laboratorios Leon Farma SA, due to the potential for a packaged unit to contain two rows of placebo instead of one row (14 tablets instead of 7 tablets) and two rows of active contraceptive tablets (14 tablets instead of 21 tablets) in the blister pack.

Pfizer Inc. announced today its investigational compound palbociclib (PD-0332991), an oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6, has received Breakthrough Therapy designation by the United States Food and Drug Administration (FDA) for the potential treatment of patients with breast cancer.

Bausch + Lomb, a global eye health company, today announced that the US Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for PROLENSA™ (bromfenac ophthalmic solution) 0.07 percent prescription eye drop.

Pfizer Inc. announced today that the European Commission (EC) has granted conditional marketing authorization for BOSULIF ® (bosutinib) in the European Union (EU) for the treatment of adult patients with chronic phase (CP), accelerated phase (AP) and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) (TKIs) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

LifeScan, Inc. is initiating a voluntary recall and replacement for all of its OneTouch ® Verio ® IQ blood glucose meters in the United States, effective immediately.