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HHS secretary Robert F. Kennedy Jr. reviews options to scale back the operational role of FDA commissioner Marty Makary, including the possibility of appointing another official to run day-to-day operations while leaving Makary as a more ceremonial figure.

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

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RFK Jr. reportedly Mulled Limiting Makary’s Authority

HHS secretary Robert F. Kennedy Jr. reviews options to scale back the operational role of FDA commissioner Marty Makary, including the possibility of appointing another official to run day-to-day operations while leaving Makary as a more ceremonial figure.

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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) tablets.

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Group Seeks Stronger Pregnancy Warning on Antidepressants

Advocacy group Public Citizen petitions FDA to add new, class-wide pregnancy warnings to the labels of commonly prescribed serotonin reuptake inhibitor antidepressants.

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NIH Grant Cuts Disrupt Hundreds of Clinical Trials: JAMA

A new JAMA research letter finds that more than 380 clinical trials supported by the NIH lost funding this year — affecting about 1 in 30 active trials and impacting more than 74,000 participants.

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Animal Drugs

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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...

medical-devices
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Guide on Biosimilar Formal Meeting Requsts

FDA releases a final guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.

Biologics

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medical-devices
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Promising Ziihera Data in Gastric Cancer Trial

Zymeworks reports that its HER2-targeted bispecific antibody Ziihera (zanidatamab-hrii) significantly improved outcomes for patients with HER2-positiv...

medical-devices
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FDA Approves First Interchangeable Perjeta Biosimilar

FDA approves Shanghai Henlius Biologics’ Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Genentech’s Perjeta (pertuzumab), a HER2-t...

medical-devices
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Outlook Therapeutics BLA Resubmitted for Wet AMD

FDA accepts for review an Outlook Therapeutics BLA resubmission for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizu...

medical-devices
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Petition Urges FDA to Ease Oversight of Stem Cell Products

A biotechnology company specializing in adult-derived stem cells urges FDA to relax federal regulation of some regenerative therapies.

FDA General

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medical-devices
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RFK Jr. reportedly Mulled Limiting Makary’s Authority

HHS secretary Robert F. Kennedy Jr. reviews options to scale back the operational role of FDA commissioner Marty Makary, including the possibility of ...

medical-devices
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FDA Previews Reforms as Pazdur Takes Over CDER

FDA commissioner Marty Makary and CBER director Vinay Prasad preview upcoming agency reforms during an FDA Direct podcast focused on the appointment o...

medical-devices
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Rising Concerns Over FDA Consistency, Transparency: Axios

An Axios report examines growing criticism of recent FDA actions that are fueling uncertainty among drug developers and weakening public confidence in...

medical-devices
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‘MAHA Summit’ to Hear from Vance, Kennedy, Makary

A MAHA Summit on 11/19 will hear from vice president JD Vance, HHS secretary Robert F. Kennedy, Jr., and FDA commissioner Marty Makary, among many oth...

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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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Group Seeks Stronger Pregnancy Warning on Antidepressants

Advocacy group Public Citizen petitions FDA to add new, class-wide pregnancy warnings to the labels ...

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NIH Grant Cuts Disrupt Hundreds of Clinical Trials: JAMA

A new JAMA research letter finds that more than 380 clinical trials supported by the NIH lost fundin...

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FDA Generic User Fee Negotiations Offer Proposals

FDA and generic drug manufacturers kick off formal negotiations on the next cycle of the Generic Dru...

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Aseptic Breakdowns at Sanofi’s Fill-Finish Plant: FDA

FDA posts a Form 483 that cites significant lapses in aseptic manufacturing practices at Sanofi’s st...

Marketing

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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...

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Create ‘Drug Facts’ Box for DTC Ads: Column

Two academic researchers urge FDA to require a Drug Facts box in direct-to-consumer ads so consumers...

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WLF Wants End to FDA TV Ad ‘Crackdown’

The Washington Legal Foundation calls on the FDA to stop its broad crackdown on drug TV advertising,...

Medical Devices

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What FDA Might Want in Chatbot Therapy for Depression

Orrick attorneys say discussions at an FDA Digital Health Advisory Committee meeting indicate the ag...

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FDA OKs Companion Diagnostic for Endometrial Cancer Therapy

FDA approves Promega’s OncoMate MSI Dx Analysis System as a companion diagnostic for identifying end...

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Complying with QMSR ‘Critical Business Strategy’: Attorneys

Alston & Bird attorneys urge medical device companies to move quickly to prepare to implement FDA’s ...

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FDA OKs Aqua Medical IDE for Endoscopic Technology Trial

FDA gives investigative device exemption approval for an Aqua Medical pilot clinical trial of its Pr...