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Hamilton Medical recalls (Class 1) certain lots of coaxial breathing sets due to a quality issue involving a defective blade in the tube-cutting stage of production that may lead to a crack in the inner blue limb of the circuit.

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Johnson & Johnson decides to stop development of nipocalimab in combination with an anti-tumor necrosis factor alpha therapy for rheumatoid arthritis after a mid-stage proof-of-concept study failed to show added benefit.

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Hamilton Recalls Defective Coaxial Breathing Sets

Hamilton Medical recalls (Class 1) certain lots of coaxial breathing sets due to a quality issue involving a defective blade in the tube-cutting stage of production that may lead to a crack in the inner blue limb of the circuit.

motusgi
Nipocalimab + Tumor Necrosis Factor in RA Nixed: J&J

Johnson & Johnson decides to stop development of nipocalimab in combination with an anti-tumor necrosis factor alpha therapy for rheumatoid arthritis after a mid-stage proof-of-concept study failed to show added benefit.

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Novocure Scraps TTFields Study for Real-World Data

Novocure stops its LUNAR-4 study, a Phase 2 open-label trial testing Tumor Treating Fields together with Merck’s Keytruda (pembrolizumab) in lung cancer (NSCLC) patients after deciding that real-world evidence can instead meet the study’s objectives.

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Platinum Biologics Selling Unapproved New Drugs: FDA

FDA warns Orlando, FL-based Platinum Biologics that it is illegally marketing unapproved new drugs.

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Animal Drugs

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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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Sen. Cassidy Seeks Postponement of Vaccine Panel

In the wake of CDC director Susan Monarez’s firing, Senate HELP Committee chair Bill Cassidy (R-LA) calls on HHS to postpone a just-announced Advisory...

medical-devices
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Limited Covid Vaccines OK’d for Upcoming Season

FDA approves supplemental BLAs from Moderna and Pfizer/BioNTech for their mRNA Covid-19 vaccines that target the LP.8.1 variant of SARS-CoV-2; the age...

medical-devices
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Innate Healthcare Illegally Marketing Stem Cells: FDA

FDA warns Scottsdale, AZ-based Innate Healthcare Institute that it is illegally marketing adulterated and misbranded stem cell products.

medical-devices
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Axogen Nerve Graft Review Extended by 3 Months

FDA extends by three months its review of an Axogen BLA for Avance Nerve Graft after the agency determined that information submitted by the company i...

FDA General

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medical-devices
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FDA Study: CBD Linked to Elevated Liver Enzymes

An FDA clinical trial finds that daily use of cannabidiol at levels typically used by consumers can cause elevated liver enzymes in otherwise healthy ...

medical-devices
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21% of FDA Staff Gone: Analysis

An in-depth ProPublica report details the effects of massive staffing cuts at FDA and other HHS agencies that experts say threaten to set back public ...

medical-devices
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Stop Inaccurate Health Info: HHS Staff to RFK, Jr.

Some 750 current and former HHSers call on secretary Robert F. Kennedy, Jr., to protect them and the rest of his staff from attacks by ending his inac...

medical-devices
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FDA Pushes Back Review of Hunter Syndrome BLA

FDA extends by 90 days its review of a Regenxbio’s BLA for RGX-121 (clemidsogene lanparvovec), an investigational gene therapy for Hunter syndrome.

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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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Nipocalimab + Tumor Necrosis Factor in RA Nixed: J&J

Johnson & Johnson decides to stop development of nipocalimab in combination with an anti-tumor necro...

motusgi
Read More
Novocure Scraps TTFields Study for Real-World Data

Novocure stops its LUNAR-4 study, a Phase 2 open-label trial testing Tumor Treating Fields together ...

motusgi
Read More
Platinum Biologics Selling Unapproved New Drugs: FDA

FDA warns Orlando, FL-based Platinum Biologics that it is illegally marketing unapproved new drugs.

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Complete Response on Telix PET Imaging Agent

FDA issues Telix Pharmaceuticals a complete response letter for its BLA seeking approval of Zircaix ...

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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Hamilton Recalls Defective Coaxial Breathing Sets

Hamilton Medical recalls (Class 1) certain lots of coaxial breathing sets due to a quality issue inv...

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Integra Recalls Surgical Applicators Over Sterility Issues

Integra LifeSciences recalls (Class 1) its Extended Tip Applicators due to sterility concerns.

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FDA Alert on Abiomed Impella Controllers

FDA issues an alert after becoming aware that Abiomed sent a letter to customers recommending that c...

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Violations in Uscom Spirometer Inspection

FDA warns Uscom Kft about Quality System violations in its illegal manufacturing and marketing of ad...