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FDA unveils a new “green list” import alert aimed at preventing unapproved and potentially unsafe GLP-1 drug ingredients from entering the U.S.

latest-news

FDA grants CERo Therapeutics fast track status for CER-1236 and its use for treating acute myeloid leukemia.

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Green List to Block Illegal GLP-1 Imports: FDA

FDA unveils a new “green list” import alert aimed at preventing unapproved and potentially unsafe GLP-1 drug ingredients from entering the U.S.

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CERo Gets Fast Track for Leukemia Therapy

FDA grants CERo Therapeutics fast track status for CER-1236 and its use for treating acute myeloid leukemia.

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FDA Expert Panels Skirt Transparency Standards: Opinion

Johns Hopkins’ drug safety expert G. Caleb Alexander says FDA’s recent use of ad hoc expert panels in place of traditional advisory committees risks undermining scientific rigor and public trust.

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FDA Probing Children’s Deaths from Covid Vaccine: Makary

FDA commissioner Marty Makary says an evaluation of reports contained in the agency’s vaccines adverse event database shows there have been Covid-19 vaccine-related deaths in children and a “proper investigation” is underway.

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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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Prasad Has Covid YouTube Videos Pulled

The Guardian says CBER director Vinay Prasad successfully had videos of him criticizing Covid vaccines removed from the YouTube channel of a physician...

medical-devices
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CBER Raising Bar on Future Covid Vaccines

Memos posted on FDA’s Web site from CBER director Vinay Prasad suggest the agency is raising the bar on future Covid-19 vaccination approvals.

medical-devices
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Shanghai Henlius’ Prolia and Xgeva Biosimilars OK’d

FDA approves two new denosumab biosimilars from Shanghai Henlius Biotech and Organon for treating osteoporosis and cancer-related bone conditions.

medical-devices
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FDA Waives Efficacy Studies for Stelara Biosimilar

FDA agrees to accept a biosimilar application to compete with Johnson & Johnson’s Stelara that does not include clinical efficacy studies for a monocl...

FDA General

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medical-devices
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RFK Jr. Grilled at Heated Senate Hearing

Bipartisan criticism of Health and Human Services secretary Robert F. Kennedy Jr. dominates a contentious three-hour Senate Finance Committee hearing ...

medical-devices
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FDA, CDC Staff Pen Open Letter to Remove RFK Jr.

Over a thousand current and former staff at FDA, CDC, and NIH pen a new open letter to HHS secretary Robert F. Kennedy Jr. and Congress, calling for K...

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 ...

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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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Green List to Block Illegal GLP-1 Imports: FDA

FDA unveils a new “green list” import alert aimed at preventing unapproved and potentially unsafe GL...

motusgi
Read More
CERo Gets Fast Track for Leukemia Therapy

FDA grants CERo Therapeutics fast track status for CER-1236 and its use for treating acute myeloid l...

motusgi
Read More
FDA Expert Panels Skirt Transparency Standards: Opinion

Johns Hopkins’ drug safety expert G. Caleb Alexander says FDA’s recent use of ad hoc expert panels i...

motusgi
Read More
FDA Probing Children’s Deaths from Covid Vaccine: Makary

FDA commissioner Marty Makary says an evaluation of reports contained in the agency’s vaccines adver...

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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Medtronic Recalls DLP Left Heart Vent Catheters

Medtronic Perfusion Systems recalls (Class 1) its DLP Left Heart Vent Catheters (malleable body and ...

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Medtronic Gets FDA Green Light for Diabetes Devices

FDA clears a Medtronic 510(k) for its MiniMed 780G insulin delivery system to integrate with Abbott’...

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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...

motusgi
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Medtronic Wins Expanded Use for Evolut Aortic Valve

FDA approves an expanded use for Medtronic’s Evolut transcatheter aortic valve replacement system, a...