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CDER Wants Access to Manufacturing Operations
FDA Places Partial Clinical Hold on CTI’s BioPharma’s Pacritinib
FDA Extends PDUFA Date of Sarepta’s DMD Candidate
BioCryst’s Avoralstat Misses Primary Endpoints
MHRA Issues Warnings for Epilepsy Drug During Pregnancy
FDA Grants Orphan Drug Designation to Atara Candidate
Epizyme Scores Win as Tazemetostat Granted Orphan Status Read More
The White House announced Monday that it plans to ask Congress for $1.8 billion in emergency funding to combat Zika, including $200 million to develop and commercialize vaccines and diagnostic tests. Read More
The FDA slammed Denmark’s Novo Nordisk for numerous GMP issues in a 13-item Form 483 for inadequate controls for sterility, environmental monitoring, labeling and written procedures. Read More
The UK’s National Institute for Health and Care Excellence has given a thumbs-down to the cholesterol drug Praluent, but a tentative nod to competitor Repatha. Read More
An update from Pfizer and Allergan on their proposed megamerger provides more insight into how Allergan product lines will be worked into Pfizer’s operating structure and various executive assignments. Read More
England’s Department of Health and NHS England have failed to manage the Cancer Drug Fund effectively by not carrying out its intended purpose and significantly outspending its budget, according to a report released by the UK Parliament’s House of Commons. Read More
Sens. Joe Manchin (D-W.Va) and Edward Markey (D-Mass.) will maintain their holds on the nomination of Robert Califf for the top job at the FDA, despite the agency’s announcement Thursday that it would overhaul its opioid policies. Read More
FDA reviewers have given their support to Celltrion’s proposed biosimilar for Remicade, finding no clinically meaningful differences between the copy and the original. Read More