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FDA approves a Kite Oncology labeling update for CAR-T therapy Yescarta (axicabtagene ciloleucel), removing a previous limitation on its use in patients with relapsed or refractory primary central nervous system lymphoma.

latest-news

FDA pledges to move quickly against companies that mass-market “illegal copycat drugs” by portraying them as equivalent to agency-approved medicines, commissioner Marty Makary says in a social media post, presumably signaling a tougher enforcement posture against compounded products like GLP-1 drugs for obesity.

LATEST NEWS

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FDA Removes Use Limitation for Yescarta in Rare Lymphoma

FDA approves a Kite Oncology labeling update for CAR-T therapy Yescarta (axicabtagene ciloleucel), removing a previous limitation on its use in patients with relapsed or refractory primary central nervous system lymphoma.

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Makary Warns ‘Illegal Copycat Drugs’ Will Face Swift Enforcement

FDA pledges to move quickly against companies that mass-market “illegal copycat drugs” by portraying them as equivalent to agency-approved medicines, commissioner Marty Makary says in a social media post, presumably signaling a tougher enforcement posture against compounded products like GLP-1 drugs for obesity.

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Breakthrough Status for Sonorous BosSTENT for Pulsatile Tinnitus

FDA grants Sonorous Neurovascular a breakthrough device designation for its BosSTENT, a cerebral venous stent designed to treat debilitating pulsatile tinnitus.

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Congress Clarifies Orphan Drug Exclusivity & Generic Transparency

A new spending package enacted this week includes two long-sought policy changes for FDA — clarifying the scope of orphan drug exclusivity and easing long-standing regulatory hurdles for generic drug developers.

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Animal Drugs

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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.

medical-devices
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10/9 Vaccines Panel to Recommend Flu Strain Selection

FDA schedules a 10/9 Vaccines and Related Biological Products Advisory Committee meeting to make recommendations on the strain selection for influenza...

medical-devices
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Capsida Pauses Gene Therapy Trial After Death

Capsida Biotherapeutics stops enrollment in its SYNRGY clinical trial that is evaluating gene therapy CAP-002 for treating STXBP1 developmental and ep...

Biologics

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medical-devices
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FDA Cautious Stance on CAR-T Cell Therapies for Autoimmune Diseases

An FDA-authored journal article signals a supportive but cautious regulatory posture toward the development of chimeric antigen receptor T-cell therap...

medical-devices
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Datroway sBLA for Triple-Negative Breast Cancer Under Review

FDA grants AstraZeneca and Daiichi Sankyo a priority review for their antibody–drug conjugate Datroway (datopotamab deruxtecan) as a potential first-l...

medical-devices
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Kennedy Ally Says Makary Blocking Covid Shot Withdrawal

Axios reports that the vice chair of the CDC Advisory Committee on Immunization Practices says the Pfizer and Moderna Covid mRNA vaccines should be re...

medical-devices
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Summit BLA for Lung Cancer Therapy

FDA accepts for review a Summit Therapeutics BLA seeking approval for ivonescimab in combination with chemotherapy in patients with epidermal growth f...

FDA General

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medical-devices
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FDA’s Expanding Role, Staff Cuts Challenge Oversight: GAO

A new GAO report finds FDA’s regulatory responsibilities expanded substantially between fiscal years 2008 and 2024, and now it faces workforce reducti...

medical-devices
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Guide on Device Cybersecurity Released

FDA posts a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.

medical-devices
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FDA Official’s Personal Legal Actions Trigger Ethics Probe

HHS Office of Inspector General begins an ethics investigation into FDA deputy chief of staff Samuel Doran and whether he misled the federal governmen...

medical-devices
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Symposium on Clinical Trials, Bioequivalence and Pharmacovigilance

U.S., U.K. and Canadian drug regulators announce a joint international symposium to discuss evolving regulatory expectations for clinical trials, bioe...

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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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FDA Removes Use Limitation for Yescarta in Rare Lymphoma

FDA approves a Kite Oncology labeling update for CAR-T therapy Yescarta (axicabtagene ciloleucel), r...

motusgi
Read More
Makary Warns ‘Illegal Copycat Drugs’ Will Face Swift Enforcement

FDA pledges to move quickly against companies that mass-market “illegal copycat drugs” by portraying...

motusgi
Read More
Breakthrough Status for Sonorous BosSTENT for Pulsatile Tinnitus

FDA grants Sonorous Neurovascular a breakthrough device designation for its BosSTENT, a cerebral ven...

motusgi
Read More
Congress Clarifies Orphan Drug Exclusivity & Generic Transparency

A new spending package enacted this week includes two long-sought policy changes for FDA — clarifyin...

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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Software Assurance Guidance Supplement

FDA publishes a guidance with recommendations on computer software assurance for computers and autom...

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J&J’s Cerenovus Recalls Neurovascular Coil Devices

Johnson & Johnson MedTech recalls multiple versions of its Cerepak Detachable Coil System, which are...

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QS Violations at Flextronics America

FDA warns Austin, TX-based Flextronics America about Quality Systems violations in its manufacturing...

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New Device Inspection Protocol Analyzed

Three Hogan Lovells attorneys analyze the new FDA medical device inspection compliance program and c...