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Medline Industries recalls (Class 1 device correction) certain lots of its Craniotomy Kits containing recalled Codman Disposable Perforators 14mm, which may come apart.

latest-news

FDA will give priority review to a Sprout sNDA to expand the indication for Addyi to treat low sexual desire in post-menopausal women.

LATEST NEWS

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Medline Recalls Craniotomy Kits

Medline Industries recalls (Class 1 device correction) certain lots of its Craniotomy Kits containing recalled Codman Disposable Perforators 14mm, which may come apart.

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FDA Priority Review for Sprout’s Addyi sNDA

FDA will give priority review to a Sprout sNDA to expand the indication for Addyi to treat low sexual desire in post-menopausal women.

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FDA to Demand New Elevidys Safety Data from Sarepta

FDA reportedly is requiring additional safety data from Sarepta Therapeutics before the agency considers supporting use of the company’s Duchenne muscular dystrophy gene therapy Elevidys.

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Abivax Favorable Data in Ulcerative Colitis Trials

Abivax announces favorable topline results from two pivotal Phase 3 induction trials of its investigational oral therapy obefazimod (ABX464) in moderately to severely active ulcerative colitis patients.

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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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FDA to Demand New Elevidys Safety Data from Sarepta

FDA reportedly is requiring additional safety data from Sarepta Therapeutics before the agency considers supporting use of the company’s Duchenne musc...

medical-devices
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RFK Jr. OK’s Directive to Ban Thimerosal in Flu Shots

HHS secretary Robert F. Kennedy, Jr. approves a new federal directive removing thimerosal, a mercury-based preservative, from all influenza vaccines d...

medical-devices
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FDA Extends Review of GSK Multiple Myeloma BLA

FDA extends by three months its review of a GSK BLA for Blenrep (belantamab mafodotin) combinations for treating patients with relapsed or refractory ...

medical-devices
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FDA Rejects Replimune BLA for Melanoma Therapy

FDA rejects a Replimune priority-reviewed BLA for its melanoma therapy RP1 (vusolimogene oderparepvec).

FDA General

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medical-devices
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HHS Finalizes FDA Employee Terminations

HHS notifies over 3,000 FDA employees that their employment has been officially terminated effective 7/14.

medical-devices
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FDA Mum on Hiring Freeze and Staff RIFs

FDA faces new uncertainty over its staffing and regulatory capacity following sweeping federal hiring restrictions and a pivotal Supreme Court decisio...

medical-devices
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Makary Touts Successes in 1st Hundred Days

FDA commissioner Martin Makary takes a 100-days-in-office victory lap, citing 32 initiatives that he says have been started to “Make America Healthy A...

medical-devices
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Senate Committee Advances FDA Budget Bill

The Senate Committee on Appropriations votes to approve and advance to a floor vote the Fiscal Year 2026 Agriculture, Rural Development, FDA and Relat...

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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 Priority Review for Sprout’s Addyi sNDA

FDA will give priority review to a Sprout sNDA to expand the indication for Addyi to treat low sexua...

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Abivax Favorable Data in Ulcerative Colitis Trials

Abivax announces favorable topline results from two pivotal Phase 3 induction trials of its investig...

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Gilead Sciences Settlement Helps 49 States

Pennsylvania attorney general Dave Sunday says 49 states are sharing a $202 million settlement with ...

motusgi
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Stakeholder Suggestions for PDUFA Reauthorization

Two stakeholders urge FDA to use the PDUFA 8 reauthorization to emphasize the need for congressional...

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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Medline Recalls Craniotomy Kits

Medline Industries recalls (Class 1 device correction) certain lots of its Craniotomy Kits containin...

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Baxter Recalls Mobile Lift Component

Baxter Healthcare recalls (Class 1) a mobile lift component used in several patient lift devices due...

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FDA Alert on Baxter’s Infusion Pump

FDA issues an early alert highlighting serious safety concerns with Baxter's Novum IQ large volume i...

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Maquet Servo Ventilators in Class 1 Recall

Maquet Critical Care recalls (Class 1) its Servo Ventilator Systems to update their use instructions...