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FDA General

Communicating Uncertainty About Drugs Granted Accelerated Approval

An education gap exists about "the possibility that these drugs might not work," says expert

FDA APPROVED ADAMTS13, recombinant-krhn (Adzynma) over a computer rendering of a blood clot.

First Treatment Approved for Genetic Clotting Disorder

Adzynma indicated as prophylactic or on-demand enzyme replacement therapy in cTTP

FDA APPROVED Chikungunya vaccine (Ixchiq) over a transmission electron microscope image of chikungunya viruses.

First Chikungunya Vaccine Lands Conditional FDA Approval

High level of seroprotection, but adverse reactions warrant postmarketing study

Competing Incentives of the FDA's Accelerated Drug Approval

Experts weigh drug availability against possible suboptimal outcomes

FDA APPROVED fruquintinib (Fruzaqla) over a computer rendering of colorectal cancer.

New Oral Drug Approved for Metastatic Colorectal Cancer

In phase III trials of pretreated patients, fruquintinib improved survival versus placebo

FDA APPROVED tirzeptide (Zepbound) over a photo of a woman holding an injection pen.

Tirzepatide Wins FDA Approval for Weight Loss

Drug also gets a new brand name, Zepbound, for its new indication

FDA APPROVED Paradise ultrasound renal denervation system over a computer rendering of the device.

FDA Approves First Renal Denervation System for Hypertension

Catheter-based technology will finally enter the market with ultrasound-based device

FDA ADCOMM Salvaged blood irradiators over a photo of a blood irradiator.

FDA Panel Backs High-Risk Designation for Salvaged Blood Irradiators

With Class III designation, sponsors would have to prove safety, efficacy with randomized trials

A photo of eye care products on the shelf of a pharmacy.

Regulation Gap Persists in OTC Eye Care Products

Poor oversight, sketchy product information endanger public health, experts say

FDA ADCOMM Salvaged blood irradiators over a photo of a blood irradiator.

Evidence of Safety, Efficacy for Salvaged Blood Irradiators Lacking, FDA Staff Say

Devices are aimed at preventing metastasis during surgery

FDA approved vonoprazan (Voquezna) over a computer rendering of pills traveling down an inflamed esophagus.

New Option Approved for Erosive Esophagitis

Vonoprazan lands indication for healing and maintenance across all grades of condition

Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.

FDA's Revolving Door; 2.4 Million Excess Deaths; Can Anorexia Be 'Terminal'?

Health news and commentary from around the Web gathered by 麻豆传媒 staff

FDA APPROVAL ustekinumab biosimilar: ustekinumab-auub (Wezlana) over a close up photo of severe psoriasis.

Stelara Biosimilar OK'd With Interchangeability

But patent settlement may keep new product off market until 2025

FDA ADCOMM exagamglogene autotemcel (exa-cel) over a computer rendering of sickle cells in the bloodstream.

Potential Cure for Sickle Cell Clears Hurdle for Approval

FDA advisors suggest the benefits of gene therapy outweigh risks of off-target editing

A photo of FDA Headquarters in Silver Spring, Maryland.

FDA Outlines Rules for Telling Clinicians About Unapproved Uses of Drugs, Devices

Draft guidance explains what doesn't qualify as "scientifically sound" information

FDA ADCOMM exagamglogene autotemcel (exa-cel) over a computer rendering of sickle cells in the bloodstream.

FDA Reviewers Question Safety of Sickle Cell Gene Therapy

Efficacy results "strongly positive," but unintended off-target effects a question

FDA APPROVED toripalimab-tpzi (Loqtorzi) over a computer rendering of nasopharyngeal cancer.

FDA OKs First Drug for Nasopharyngeal Carcinoma

Toripalimab approved in combination with first-line chemo, and as monotherapy after progression

A photo of a female physician sitting on the edge her senior female patient鈥檚 bed in her home.

What if Trial Participants Knew Their Contributions Were for Naught?

A call for enforcing trial reporting requirements

FDA APPROVED mirikizumab-mrkz (Omvoh) over a computer rendering of ulcerative colitis.

Novel Drug OK'd for Ulcerative Colitis

First agent to target p19 subunit of IL-23

Onco Break over a computer rendering of a cancer cell.

Soap to Fight Skin Cancer; $1,000 Early Cancer Detection Test; FDA Approval in MDS

News, features, and commentary about cancer-related issues

FDA APPROVED vamorolone (Agamree) over a photo of a female physical therapist and a little boy with muscular dystrophy.

Novel Corticosteroid Approved for Rare Disease

Vamorolone gets a nod from FDA for Duchenne muscular dystrophy

FDA WARNING Probiotic products for preterm infants over a photo of a preterm infant in an incubator.

Probiotics for Preterm Infants Could Pose Serious Danger, FDA Warns

Abbott, Infinant Health sent warning letters about their products

AAP over a photo of Walter E. Washington Convention Center in Washington, DC.

AAP Warns on So-Called Toddler Formulas

Beverages are "not nutritionally complete" and not meant for kids with major illness, report says

The advertisement for this Instagram Live event.

IG Live October 23: Life in the Fast Lane With FDA's Accelerated Approvals

Experts share their perspectives on the increasingly controversial FDA pathway

FDA APPROVED pilocarpine hydrochloride ophthalmic solution (Qlosi) over a photo of a man struggling to see his phone.

Eye Drops for Presbyopia Win FDA Approval

Pilocarpine hydrochloride solution improved distance-corrected vision in two phase III trials

FDA APPROVED tenapanor (Xphozah) over a computer rendering of chronic kidney disease.

FDA Approves First Phosphate Absorption Inhibitor for CKD

Tenapanor indicated for adults on dialysis who fail on phosphate binders

FDA APPROVED pembrolizumab (Keytruda) + platinum-containing chemotherapy over a computer rendering of lung cancer.

Pembrolizumab Wins FDA Approval in Operable Lung Cancer

Checkpoint inhibitor demonstrated significant survival improvement in perioperative setting

Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.

Suzanne Somers Dies; FDA Plans to Ban Hair Relaxers; Health Worker Minimum Wage

Health news and commentary from around the Web gathered by 麻豆传媒 staff

FDA approved oral etrasimod (Velsipity) over a computer rendering of ulcerative colitis.

New Oral Drug Approved for Ulcerative Colitis in Adults

S1P receptor modulator etrasimod indicated for moderately to severely active disease

A photo of a laboratory technician slicing umbilical cord tissue samples.

FDA Warns That Umbilical Cord Injection Is a Drug

Company owner also has a stem cell clinic in Panama claiming to treat various conditions

FDA APPROVED encorafenib (Braftovi) over a computer rendering of lung cancer.

Combination Therapy Wins FDA Approval for BRAF-Mutated NSCLC

Encorafenib plus binimetinib led to 75% ORR in untreated patients, 59% in treated patients

FDA WARNING Compounded ketamine products over a photo of a woman using nasal spray.

FDA Warns on Compounded Ketamine for Psych Disorders

The agency emphasized the drug is not approved for any psychiatric disorder

HFSA over a photo of Huntington Convention Center in Cleveland, Ohio.

FDA Turns Down ATTR Cardiomyopathy Drug

Decision cites insufficient evidence of clinical meaningfulness

FDA ADCOMM sotorasib (Lumakras) over a chest x-ray image of a patient with lung cancer.

Sotorasib's Confirmatory Data in NSCLC Unreliable, Says FDA Panel

But聽agency doesn't plan to immediately push for KRAS inhibitor's withdrawal

FDA ODAC eflornithine (DFMO) over a photo of a little girl battling neuroblastoma.

FDA Panel Endorses DFMO for Kids' High-Risk Neuroblastoma in Remission

Large improvement in event-free survival, but questions linger about sources of data

A photo of a bottle of Exkivity capsules over a computer rendering of lung cancer.

Drugmaker Plans to Pull Lung Cancer Therapy From the Market

Randomized trial of mobocertinib (Exkivity) failed to confirm聽benefit in rare tumor type

FDA ADCOMM sotorasib (Lumakras) over a chest x-ray image of a patient with lung cancer.

FDA Staff Highly Skeptical of Confirmatory Data on KRAS Inhibitor in NSCLC

Reviewers see potentially tiny PFS benefit with sotorasib, raise concerns over "systemic bias"

FDA EUA Novavax COVID-19 Vaccine over a photo of a person holding a vial of Nuvaxovid.

Novavax's Updated COVID Shot Authorized by FDA

Protein-based vaccine is refreshed with 2023-2024 formula targeting XBB strain

FDA ODAC eflornithine (DFMO) over a photo of a little girl battling neuroblastoma.

FDA Advisors to Consider DFMO Maintenance for High-Risk Neuroblastoma in Kids

Lack of options for relapsed disease versus uncertainty about supporting data

A computer rendering of RSV viruses.

A Framework to Communicate With Pregnant Patients About the RSV Vaccine

A values-based decision-making framework is key

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