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Human Drugs

Acadia Gets 2nd Complete Response on Alzheimer's Drug

FDA issues Acadia Pharmaceuticals a second complete response letter on its supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations an...

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Human Drugs

Merck Refiling Gedapixant NDA Next Year

Merck says it will file a response next year to an FDA complete response letter it received in January on an NDA for gefapixant and its use for treati...

FDA General

Delayed User Fee Reauthorization Will Hurt Recruitment: Woodcock

Principal deputy commissioner Janet Woodcock says the user fee impasse on Capitol Hill will likely damage ongoing recruitment efforts to bring onboard...

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Medical Devices

CDRH Wants Proposals on Device Learning Site Visits

CDRH seeks proposals for medical device site visits as part of its Experiential Learning Program, which is intended to educate the Center on how new t...

Human Drugs

Former FDAer Joins Sidley

Former CDER combination product team leader Jay Jariwala joins the Sidley law firm.

Human Drugs

Keytruda, Lenvima Flunk uHCC Trial

Merck and Eisai say the combination of Keytruda and Lenvima failed to meet two primary endpoints in a test of patients with unresectable hepatocellula...

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Resume User Fee Talks: Disease Interests

Some 99 health-related advocacy and service groups call on Congress to resume consensus talks on user fee reauthorization legislation.

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Human Drugs

Pfizer Ditches Cardiomyopathy Drug After Trial Miss

Pfizer discontinues developing PF-07265803 in patients with symptomatic dilated cardiomyopathy after an interim futility analysis of the global Phase ...

Human Drugs

Regenxbio to File BLA for Hunter Syndrome Treatment

Regenxbio plans a BLA using the accelerated approval pathway for its RGX-121 Hunter Syndrome treatment.

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Human Drugs

Aurobindo Hit with FDA-483 After Inspection

FDA issues a Form FDA-483 to Aurobindo Pharma, citing three observations after investigators inspected the firms Unit XI, an active pharmaceutical ing...