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FDA

Latest Headlines

Latest Headlines

Celltrion's biosimilar of J&J's Remicade reviewed favorably by FDA staffers

FDA staff reviewers were supportive of the Remicade biosimilar from Celltrion ahead of next week's advisory committee meeting. The reviewers said that the drug is "highly similar" to the branded product in terms of safety, purity and potency. 

FDA's Califf calls for 'sweeping re-examination' of policies in effort to fight opioid abuse

The FDA has been repeatedly criticized for expanding approvals for opioids in the face of an "epidemic" of abuse and overdoses. Today Dr. Robert Calif, President Obama's pick to head the agency, took that matter head-on, calling for a sweeping review of the agency's policies.

Blockbuster new launches coming from Intercept, Gilead and Merck: Reuters

The pharma industry heralded 11 new blockbusters in 2015, an act that's tough to follow. But while 2016 may not see quite that many, it's still on track to ring in 7 new therapies that have a shot at cracking the billion-dollar sales mark, a new analysis says.

More link think? OPDP lists social media links as guidance item for 2016

The FDA's promotional police plan to address social media links for pharma again this year. Maybe. That is, the issue is on the agency's annual agenda of "new and revised draft guidances CDER is planning to publish during calendar year 2016." 

India's Wockhardt knocked again by U.S. FDA

Mumbai-based drugmaker Wockhardt is once again in the crosshairs of the U.S. Food and Drug Administration (FDA) after the American regulator found the pharma giant was hiding the results from failed tests on drugs and deleting the resulting data from computer systems at a plant in western India, according to a report by Reuters.

Roche/AbbVie's venetoclax grabs third FDA 'breakthrough' for blood cancer

AbbVie and Roche's venetoclax has received yet another accelerated review from the FDA--this time in patients with the most common type of acute leukemia.

FDA releases guidance on improving medical device interoperability

Interoperability is an increasingly important component of med tech, due to the need for communication and data exchange within a networked system of other devices, electronic health records and clinicians. Poor interoperability is blamed for problems like "alarm fatigue" whereby poorly networked devices produce an excessive number of loud warnings out of an abundance of caution, leading to the risk that a necessary alarm will be ignored.

BMS' Opdivo evens the score in melanoma with two new FDA green lights

Thanks to an FDA decision over the weekend, Bristol-Myers Squibb's immunotherapy Opdivo has caught back up to Merck's Keytruda in melanoma. And it won a new combination approval from the FDA to boot.

FDA bans products from China plant used by Big Pharma players

A Chinese ingredient maker who has produced ingredients for some of the big guns in pharma including Novartis, Sanofi and Pfizer is getting its products banned by the FDA.

FDA slaps Pfizer's Hospira unit for 'misleading' YouTube ad

In the first enforcement action from the FDA's marketing police this year, the Office of Prescription Drug Promotion put Hospira in the hot seat over a YouTube video for its sedative Precedex.