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Human Drugs

Vanda Wins Long-Sought Hearing on Hetlioz sNDA for Jet Lag

FDA grants Vanda Pharmaceuticals a long-sought formal evidentiary public hearing to review the agency’s proposal to refuse approval of a supplemental NDA for Hetlioz (tasimelteon) and its use for treating jet lag disorder.

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Human Drugs

FDA Hits Novo Nordisk Over Ozempic Ad

FDA cites a Novo Nordisk direct-to-consumer advertisement for its blockbuster diabetes drug Ozempic (semaglutide), calling the ad misleading and violating federal drug promotion rules.

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Human Drugs

FDA Hits Novo Nordisk Over Ozempic Ad

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Biologics

Regenxbio’s Complete Response Letter Released

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Human Drugs

Fukuzyu FDA-483 Out

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Human Drugs

FDA Working on Peptide Accessibility: Politico

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Vanda Wins Long-Sought Hearing on Hetlioz sNDA for Jet Lag

FDA grants Vanda Pharmaceuticals a long-sought formal evidentiary public hearing to review the agency’s proposal to refuse approval of a supplemental NDA for Hetlioz (tasimelteon) and its use for treating jet lag disorder.

motusgi
FDA Hits Novo Nordisk Over Ozempic Ad

FDA cites a Novo Nordisk direct-to-consumer advertisement for its blockbuster diabetes drug Ozempic (semaglutide), calling the ad misleading and violating federal drug promotion rules.

motusgi
Regenxbio’s Complete Response Letter Released

FDA posts a complete-response letter that outlined last month's rejection of Regenxbio’s BLA for its gene therapy clemidsogene lanparvovec.

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FDA Working on Peptide Accessibility: Politico

Politico reports that HHS secretary Robert F. Kennedy Jr. said FDA will soon approve a way to make some peptides more accessible to the public.

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Animal Drugs

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FDA Warns Elanco Animal Health About Pradalex Ads

The Center for Veterinary Medicine warns Elanco Animal Health about false and misleading claims in promotional materials for its Pradalex that treats ...

medical-devices
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Antimicrobial Drug Duration of Use Guidance

FDA publishes a guidance with recommendations for how sponsors of animal drugs may facilitate changes to the approved conditions of use of specific ty...

medical-devices
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Sangamo Begins Rolling BLA for Fabry Gene Therapy

Sangamo Therapeutics begins a rolling BLA submission seeking accelerated approval of its experimental Fabry disease gene therapy, following result...

medical-devices
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Sydnexis Pediatric Myopia Drug Meets Endpoints

Sydnexis says its SYD-101 drug to treat pediatric progressive myopia met both the primary and key secondary endpoints in the Phase 3 STAR trial.

Biologics

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medical-devices
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Regenxbio’s Complete Response Letter Released

FDA posts a complete-response letter that outlined last month's rejection of Regenxbio’s BLA for its gene therapy clemidsogene lanparvovec.

medical-devices
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FDA Wants Randomized Trial for Huntington’s Gene Therapy

FDA recommends that uniQure conduct a randomized, double-blind, sham surgery-controlled trial before seeking BLA approval for its Huntington’s disease...

medical-devices
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Pfizer CEO Concerned About FDA Vaccines Chief

Pfizer CEO Albert Bourla tells TD Cowen healthcare conference that the leadership of FDA’s biologics center is worrisome because it disregards the rec...

medical-devices
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FDA Accepts Vanda BLA for Rare Skin Disorder Drug

FDA accepts for review a Vanda Pharmaceuticals BLA for imsidolimab, a potential new treatment for generalized pustular psoriasis.

FDA General

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medical-devices
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Ex-FDA Leaders Accuse Trump Admin of Distorting Contraceptive Science

Three former senior FDA officials tell a federal appeals court that the Trump administration mischaracterized the science on contraceptive safety when...

medical-devices
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FDA Employees Told Not to Use Claude AI in Tech Dispute

HHS directs FDA and other health agency employees to immediately stop using the artificial intelligence platform Claude after the Trump administration...

medical-devices
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Makary Defends Approval Standards and Prasad’s Role

FDA commissioner Marty Makary defends the agency’s scientific standards and personnel, particularly CBER director Vinay Prasad, amid mounting politica...

medical-devices
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FDA Emphasizes Confidentiality as Foundation of Public Trust, Innovation

An FDA Voices post by FDA chief operating officer Barclay Butler says the agency’s ability to uphold the “gold standard” of regulatory review depends ...

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Federal Register

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PDUFA Public Meeting for User Fee Reauthorization

Federal Register notice: FDA announces a 7/14 public meeting to discuss proposed recommendations for...

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Generic Drug Fee Program Reauthorization Meeting

Federal Register notice: FDA hosts a 7/11 public meeting on the reauthorization of the Generic Drug ...

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FDA Withdraws and Reissues 2 Guidances

FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissui...

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CDER Continues Quality Management Program

Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second ye...

Human Drugs

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Vanda Wins Long-Sought Hearing on Hetlioz sNDA for Jet Lag

FDA grants Vanda Pharmaceuticals a long-sought formal evidentiary public hearing to review the agenc...

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Read More
FDA Hits Novo Nordisk Over Ozempic Ad

FDA cites a Novo Nordisk direct-to-consumer advertisement for its blockbuster diabetes drug Ozempic ...

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Read More
FDA Working on Peptide Accessibility: Politico

Politico reports that HHS secretary Robert F. Kennedy Jr. said FDA will soon approve a way to make s...

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Time to Update FDA SUPAC Guidances

FDA seeks public input on whether to revise a longstanding series of manufacturing guidance document...

Marketing

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Neffy Broadcast Ad ‘False or Misleading’: OPDP

An FDA Untitled Letter cautions ARS Pharmaceutical about false or misleading claims for its Neffy na...

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Cobenfy Ad Letter Signals Tight Limits on DTC Claims: Attorneys

A December FDA violation letter targeting a schizophrenia drug advertisement from Bristol Myers Sq...

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FDA Flags AstraZeneca’s Farxiga TV Ad as Misleading

FDA cites a direct-to-consumer television advertisement for AstraZeneca’s Farxiga (dapagliflozin) ta...

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Oversight of Influencer Social Media Posts Hard: Researchers

University of Chicago researchers explain how difficult it will be to improve government oversight o...

Medical Devices

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Synergy Spine’s Artificial Cervical Disc Approved

FDA approves a Synergy Spine Solutions PMA for its Synergy Disc, a motion-preserving artificial cerv...

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Fresenius Recalls Ivenix Pumps Over Software Issue

Fresenius Kabi recalls its Ivenix Large Volume Pump due to a software issue.

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Alert on Abiomed Heart Pumps

FDA issues an early alert about a potentially high-risk problem involving certain heart pump compone...

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AdvaMed Presses FDA to Anchor Federal Strategy on Clinical AI

AdvaMed urges federal health officials to keep FDA at the center of oversight for artificial intelli...