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Pfizer and BioNTech file an application seeking an emergency use authorization for their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine as the third dose in a primary series in kids aged six months through four years of age.

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FDA confirms the survival rate of Abiomed’s Impella RP System that was required to undergo a post-approval study after being approved in 2017.

LATEST NEWS

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Firms Seek EUA for Omicron Vaccine in Young Children

Pfizer and BioNTech file an application seeking an emergency use authorization for their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine as the third dose in a primary series in kids aged six months through four years of age.

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FDA Confirms Survival Rate With Abiomed’s Heart Device

FDA confirms the survival rate of Abiomed’s Impella RP System that was required to undergo a post-approval study after being approved in 2017.

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Clinical Hold Issues Outlined for Cholesterol Gene Therapy

FDA issues Verve Therapeutics a formal clinical hold letter that outlines the information required to resolve a hold that was placed 11/4 on VERVE-101 and a study in patients with heterozygous familial hypercholesterolemia.

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Novartis Seeking Expanded Pluvicto Use

Novartis says it will seek FDA approval for an expanded use for Pluvicto (lutetium Lu 177 vipivotide tetraxetan), for slowing disease progression in certain adults with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer and who have not yet been treated with taxane-based chemotherapy.

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Animal Drugs

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Generic Adspec Approved for Bovine Pneumonia

FDA approves Bimeda Animal Health’s SpectoGard (spectinomycin sulfate), the first generic copy of Pharmacia Animal Health’s Adspec.

medical-devices
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Animal Drug Compounding Guidance

FDA publishes a final guidance on its approach to enforcement involving animal drugs compounded from bulk drug substances.

medical-devices
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FDA Promotes New Approaches to Animal Drug Approval

FDA publishes four final guidances encouraging new sponsors of new animal drugs to pursue innovative ways to prepare and submit data for FDA evaluatio...

medical-devices
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FDA OKs Tanovea for Lymphoma in Dogs

FDA approves VetDC’s Tanovea (rabacfosadine injection) to treat lymphoma in dogs.

Biologics

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medical-devices
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Firms Seek EUA for Omicron Vaccine in Young Children

Pfizer and BioNTech file an application seeking an emergency use authorization for their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine as the th...

medical-devices
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FDA Rejects Y-mAbs BLA for Brain Condition

FDA sends Y-mAbs Therapeutics a complete response letter on its BLA for I-omburtamab and its use in treating CNS/leptomeningeal metastasis from neurob...

medical-devices
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FDA Grants, Denies Parts of Microbiome Petition

FDA grants one part and denies another part of a petition submitted by the Microbiome Therapeutic Innovation Group by publishing a final policy on fec...

medical-devices
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Janssen Sues Amgen Over Stelara Biosimilar Plans

Janssen files a patent infringement suit against Amgen and its plans to seek FDA approval and market a biosimilar copy of Janssen’s blockbuster Stelar...

FDA General

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medical-devices
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Biden Signs Medical Marijuana/Cannabidiol Research Law

President Biden signs into law HR 8454, the “Medical Marijuana and Cannabidiol Research Expansion Act.”

medical-devices
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FDA Modeling, Simulation Successes

The FDA Modeling and Simulation Working Group issues a report on how modeling and simulation are used within and across FDA Centers and opportunities ...

medical-devices
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Bernie Sanders to Head HELP Committee

Senator Bernie Sanders (I-VT) looks to become chairman of the Health, Education, Labor and Pensions (HELP) Committee after current chair Patty Murray ...

medical-devices
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FDA Cybersecurity Modernization Action Plan

Two FDA information technology executives describe the agency’s new cybersecurity modernization action plan.

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Federal Register

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Guide on Bioequivalence Statistical Approaches

Federal Register notice: FDA makes available a draft guidance entitled “Statistical Approaches to Es...

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Draft Guide on ANDA Pre-inspection Correspondence

Federal Register notice: FDA makes available a revised draft guidance entitled “ANDAs: Pre-Submissio...

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Oncologic Drugs Committee Renewed for 2 Years

Federal Register notice: FDA announces the renewal of its Oncologic Drugs Advisory Committee for an ...

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HHS Delegates Authorities to FDA/NIH for ALS Partnership

Federal Register notice: HHS delegates to FDA and NIH authorities under the Accelerating Access to C...

Human Drugs

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Clinical Hold Issues Outlined for Cholesterol Gene Therapy

FDA issues Verve Therapeutics a formal clinical hold letter that outlines the information required t...

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Novartis Seeking Expanded Pluvicto Use

Novartis says it will seek FDA approval for an expanded use for Pluvicto (lutetium Lu 177 vipivotide...

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Guide on ‘Selective’ Drug Safety Data Collection

FDA posts a final guidance entitled “E19 A Selective Approach to Safety Data Collection in Specific ...

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FDA Accepts Protalix, Chiesi Fabry Disease BLA Resubmission

FDA accepts for review a Protalix BioTherapeutics and Chiesi BLA resubmission for PRX–102 (pegunigal...

Marketing

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ZoomRx Keys to Better Oncology Promo Messaging

ZoomRx suggests three ways to create effective oncology promotional messages directed to healthcare ...

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OPDP Wants to Research Drug Name Interpretation

The CDER Office of Prescription Drug Promotion says it wants to research how consumers and healthcar...

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OPDP to Study TV Ad Endorsers

The CDER Office of Prescription Drug Promotion says it wants to expand a current study on endorsers ...

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2 Prescription Drug Promotion Studies Proposed

The CDER Office of Prescription Drug Promotion proposes to study consumer and healthcare provider pe...

Medical Devices

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FDA Confirms Survival Rate With Abiomed’s Heart Device

FDA confirms the survival rate of Abiomed’s Impella RP System that was required to undergo a post-ap...

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Getinge Intra-Aortic Balloon Pumps on Shortage Lis

FDA adds Getinge Maquet/Datascope Intra-Aortic Balloon Pump devices to its device shortage list.

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FDA Hits Cutera With Warning on Web Site Promo

FDA sends Cutera a Warning Letter related to marketing material that appeared on a company owned Web...

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Medtronic HeartWare ‘Dear Doctor’ Letter

A Medtronic “Dear Doctor” letter describes a potential issue with the driveline cover in its HeartWa...