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Boehringer Ingelheim says its investigational kidney drug apecotrep reduced proteinuria by 40% compared with placebo in a Phase 2 clinical trial involving patients with primary focal segmental glomerulosclerosis.

latest-news

Faced with a legal deadline for a response, FDA denies without comment on the specifics a law firm’s petition seeking restrictions on approval of generic Ozempic.

LATEST NEWS

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Boehringer Ingelheim Reports Data on Kidney Drug

Boehringer Ingelheim says its investigational kidney drug apecotrep reduced proteinuria by 40% compared with placebo in a Phase 2 clinical trial involving patients with primary focal segmental glomerulosclerosis.

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FDA Denies Ozempic Petition Without Substantive Comment

Faced with a legal deadline for a response, FDA denies without comment on the specifics a law firm’s petition seeking restrictions on approval of generic Ozempic.

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CGMP Issues at Malaysia’s Fulijaya Manufacturing

FDA warns Malaysia’s Fulijaya Manufacturing about CGMP violations in its production of finished drugs.

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Using AI in Tumor Assessment

A Friends of Cancer Research white paper explores the emerging role of AI-enabled tumor assessment tools and the framework needed to use them in validating trial endpoints.

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Animal Drugs

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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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Sarepta Reports Positive Data on Duchenne Gene Therapy

Sarepta Therapeutics announces that its gene therapy Elevidys significantly slowed disease progression over three years in ambulatory patients with Du...

medical-devices
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Advocacy Push Precedes FDA Meeting on Stalled Gene Therapy

AMT-130 is a gene therapy designed to lower levels of the mutant huntingtin protein believed to drive Huntington’s disease progression.

medical-devices
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Scancell Advancing iSCIB1+ Into Phase 3 Melanoma Trial

FDA approves a Scancell Holdings IND to begin a registrational Phase 3 trial of iSCIB1+ in patients with advanced melanoma.

medical-devices
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Moderna/Merck Report Positive Data on Melanoma Vaccine

Moderna and Merck report updated five-year follow-up data that show their personalized mRNA cancer vaccine candidate, intismeran autogene, significant...

FDA General

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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...

medical-devices
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Pazdur Warns About Political Interference, Upheaval At FDA

Former FDA Oncology Center for Excellence director Richard Pazdur warns that political interference and internal upheaval are eroding the agency’s abi...

medical-devices
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Harvard Law Hits User Fees Over ‘Corporate Capture’

A new analysis from Harvard Law School argues that the U.S. drug regulator’s reliance on industry-paid user fees has left the agency vulnerable to bot...

medical-devices
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End-of-December Warning Letters

FDA releases substantive Warning Letters in the last two weeks of December 2025.

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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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Boehringer Ingelheim Reports Data on Kidney Drug

Boehringer Ingelheim says its investigational kidney drug apecotrep reduced proteinuria by 40% c...

motusgi
Read More
FDA Denies Ozempic Petition Without Substantive Comment

Faced with a legal deadline for a response, FDA denies without comment on the specifics a law firm’s...

motusgi
Read More
CGMP Issues at Malaysia’s Fulijaya Manufacturing

FDA warns Malaysia’s Fulijaya Manufacturing about CGMP violations in its production of finished drug...

motusgi
Read More
Using AI in Tumor Assessment

A Friends of Cancer Research white paper explores the emerging role of AI-enabled tumor assessment t...

Marketing

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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...

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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...

Medical Devices

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Warning Letter Issued to Meridian Bioscience

FDA sends a Warning Letter to Meridian Bioscience over serious quality system violations involving b...

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FDA Warns MAST Biosurgery Over Manufacturing Violations

FDA issues MAST Biosurgery a Warning Letter after an August inspection cited serious manufacturing q...

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FDA OKs Guardant360 CDx Companion Diagnostic

FDA approves Guardant Health’s Guardant360 CDx liquid biopsy as a companion diagnostic to identify p...

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Draft Guide on Blood Pressure Monitoring Sensors

FDA issues a draft guidance detailing expectations for how makers of cuffless, non-invasive blood pr...