Latest News & Analysis
Opdivo has a new rival in the lung cancer setting in Japan following the reimbursement and launch of Keytruda at the same daily price.
La Jolla Pharmaceutical's angiotensin II drug LJPC-501 is on track for NDA via SPA this year, after meeting blood pressure increase primary endpoint in ATHOS-3, but also showing a trend toward an overall survival benefit.
OPDP chief Abrams did not give many general tips for complying with guidance on off-label promotion 'consistent with' FDA-approved labeling, leaving sponsors to make own interpretations.
Inspirion’s MorphaBond win suggests agency’s thinking on three-year exclusivity for abuse-deterrent formulations has ‘evolved’ from a formulation-specific approach to one based on route of abuse.
Sens. Pat Roberts, R-KS, and Heidi Heitkamp, D-ND, and Reps. Lynn Jenkins, R-KS and Ron Kind, D-WI, once again introduce the Restoring Access to Medications Act, proposing amending rather than repealing ACA.
'We have a lot of red tape, but we have a clear red tape,' attorney José Alberto Campos-Vargas says in an interview.
CDC advisory committee wants vaccine effectiveness data for H1N1 component but that is not the predominant strain this season; AstraZeneca is not giving up.
Despite the voluntary nature of US FDA’s program, an agency official urges full participation. Without data from such participation, FDA will not be able to predict drug shortages and industry will not see the benefits of reduced inspections and streamlined change control.
The latest drug development news and highlights from our FDA Performance Tracker.
Against backdrop of subdued trial activity in the country and concerns about injury compensation, Indian Society for Clinical Research and Harvard's MRCT Centre offer a portal to facilitate a more objective assessment of causality of serious adverse events.
The International Council for Harmonisation has proposed major changes to its good clinical practice requirements in a bid to allay concerns about the problems they pose in conducting well-designed randomized trials. The revised GCP framework would also address the increasing diversity of clinical trial designs and data sources.
The UK's decision to leave the European Union and a change in global politics that has prompted emotions to get in the way of facts are the catalysts for Europe's current identity crisis, says Bayer chief Werner Baumann. During the company's annual financial results presentation in Leverkusen, Germany, the CEO also called on European regulators to better protect innovation during times of political uncertainty.
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