The agency has recommended marketing authorization for Ibrance in the European Union.

In response to the EpiPen pricing scandal, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, clarifies FDA’s role in drug pricing.

Bayer will acquire the agricultural company for $66 billion in an all cash transaction.

Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.

Virtus Pharmaceuticals Opco II, LLC is voluntarily recalling batches of hyoscyamine sulfate (0.125mg).

The project aims to address challenges facing the development, manufacture, and delivery of vaccines.

The organization announced the winners of the 2016 awards at a dinner on Sept. 13 in Washington DC.

Allergan will acquire Vitae pharmaceuticals for $639 million.

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.

The Novelia system has been approved as a packaging component and delivery system of multidose drug product formulated without preservatives.

Catalent will acquire Pharmatek, a San Diego-based manufacturer of oral, injectable, and topical products.

Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.

The company voluntarily recalled the product due to detached needles on the syringe in the kit.

As part of a planned process to replace venture-capital financial partners, Suanfarma S.A. has acquired a stake in Idifarma.

Following the United Kingdom’s decision to leave the European Union, there are two areas that demand attention-clinical trials and marketing authorization

Horizon Pharma will acquire Raptor Pharmaceuticals with the transaction expected to close in the fourth quarter of 2016.

The companies launched Onduo, a joint venture focused on developing solutions to assist patients with Type 2 diabetes.

Results show the drug was effective at reducing the risk of uveitic flare or visual impairment.

A customer complaint revealed microbial contamination issues affecting lots with expiration dates in late 2018 and early 2019.

Mumbai, the location for its new Indian subsidiary, will also be the site for the company's Uniquity Global Conference on October 6, 2016.

Analysts examine the latest trends in finished dosage forms.

The company will be releasing its new 3C technology for omega 3 EPA and DHA at CPhI Worldwide.

The company will showcase its injectable grade pharmaceutical oils at CPhI Worldwide.

The company will display new products such as the Opadry QX, a tablet film coating.

The panel includes 12 experts from a variety of disciplines.

FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A for CGMP violations.

The Indian facility was cited for a range of quality and data integrity violations.

The agency published a guideline for the implementation of ICH Q3D.