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Staffing cuts and other administrative disorders leads to a review extension on a clinical hold review on Neurizon Therapeutics’ NUZ-001 and its use for amyotrophic lateral sclerosis.

latest-news

FDA issues an alert on all Baxter Novum IQ Large Volume Pumps and Novum IQ Syringe Pumps after becoming aware of a company notification to users that the devices’ software should be corrected before continued use.

LATEST NEWS

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FDA Delays Clinical Hold Review on Neurizon ALS Drug

Staffing cuts and other administrative disorders leads to a review extension on a clinical hold review on Neurizon Therapeutics’ NUZ-001 and its use for amyotrophic lateral sclerosis.

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FDA Alert on Baxter Novum Infusion Pumps

FDA issues an alert on all Baxter Novum IQ Large Volume Pumps and Novum IQ Syringe Pumps after becoming aware of a company notification to users that the devices’ software should be corrected before continued use.

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Omeros BLA for Narsoplimab Gets Review Extension

FDA extends by three months its review of an Omeros resubmitted BLA for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy.

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FDA OKs Papzimeos for Respiratory Papillomatosis

FDA approves a Precigen BLA for Papzimeos (zopapogene imadenovec-drba), a non-replicating adenoviral vector-based immunotherapy for treating adult patients with recurrent respiratory papillomatosis.

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Animal Drugs

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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.

medical-devices
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Sumitomo Pharma Gets Fast Track Status for Nuvisertib

FDA grants Sumitomo Pharma a fast-track designation for nuvisertib (TP-3654) for treating patients with intermediate or high-risk myelofibrosis.

medical-devices
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Researchers Challenge FDA Lamictal Safety Warning

Rutgers University researchers say they have determined that the GlaxoSmithKline anti-seizure drug Lamictal is safe for adults with epilepsy and conco...

medical-devices
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GSK Plans for Antibiotic NDA in 2nd Half

GSK plans to submit an NDA in the second half of the year after it and Spero Therapeutics announced that they will end their Phase 3 PIVOT-PO clinical...

Biologics

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medical-devices
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Omeros BLA for Narsoplimab Gets Review Extension

FDA extends by three months its review of an Omeros resubmitted BLA for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microa...

medical-devices
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BEAM-101 Gets Advanced Therapy Designation

FDA grants Beam Therapeutics a Regenerative Medicine Advanced Therapy designation for BEAM-101, an investigational gene-edited cell treatment for sick...

medical-devices
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HHS Revives Task Force on Safer Child Vaccines

HHS revives a task force on safer childhood vaccines, a federal panel created by Congress to improve child vaccine safety, quality, and oversight.

medical-devices
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FDA May Nix Pfizer EUA for Covid Jab in Young Kids

The Guardian reports that the emergency use authorization for Pfizer’s Covid-19 vaccine for children under five may not be renewed by FDA this fall.

FDA General

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medical-devices
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FDAer Quits, Flips Off Trump/Vance in Viral Post

FDA Office of Privacy information specialist Elizabeth Booker Houston’s recent departure goes viral after dramatically announcing her resignation with...

medical-devices
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Agency RIF Packets Cause Privacy Concerns

Some fired FDA employees say they received sensitive information about other employees in addition to their own.

medical-devices
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Laura Loomer Targets Makary Over Prasad Exit

Right-wing commentator Laura Loomer publicly criticizes FDA commissioner Marty Makary over recent comments surrounding the departure and mooted return...

medical-devices
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Former FDA Staff Chief Joins Hogan Lowells

Former FDA chief of staff Elizabeth Jungman joins law firm Hogan Lovells as a partner in its pharmaceuticals and biotechnology practice in the Washing...

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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 Delays Clinical Hold Review on Neurizon ALS Drug

Staffing cuts and other administrative disorders leads to a review extension on a clinical hold revi...

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FDA OKs Papzimeos for Respiratory Papillomatosis

FDA approves a Precigen BLA for Papzimeos (zopapogene imadenovec-drba), a non-replicating adenovir...

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Sickle Cell Drug Misses Phase 3 Endpoint: Pfizer

A Phase 3 study of Pfizer’s investigational sickle cell disease drug inclacumab fails to meet the pr...

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Group Pushes MDMA-Assisted Therapy for PTSD

The Multidisciplinary Association for Psychedelic Studies calls on HHS and FDA to quickly approve it...

Marketing

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Bill to Require Drug Price in DTC Ads

Five House members introduce a bill to require DTC television ads to include the drug’s list price.

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Sen. Durbin Calls for Crackdown on DTC Telehealth

Senator Dick Durbin (D-IL) calls for a crackdown on pharmaceutical companies’ growing use of direct-...

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DTC Ads Kennedy’s Next Target?

Bloomberg News says President Trump and HHS secretary Kennedy are looking at policies that they hope...

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Senators Introduce Bill to Ban DTC Drug Advertising

Senators Bernie Sanders (I-VT) and Angus King (I-ME) introduce legislation that would ban direct-to-...

Medical Devices

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FDA Alert on Baxter Novum Infusion Pumps

FDA issues an alert on all Baxter Novum IQ Large Volume Pumps and Novum IQ Syringe Pumps after becom...

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Alert on Medtronic DLP Left Heart Vent Catheters

FDA issues an alert after becoming aware that Medtronic recently sent a letter to customers recommen...

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Thoratec Recalls HeartMate Mobile AC Power Cord

Thoratec recalls (Class 1) its HeartMate Mobile Power Unit AC power cord due to unintended power dis...

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De Novo OK for ArteraAI Prostate Software

FDA grants de novo authorization for the ArteraAI Prostate test, a risk-stratification tool to help ...