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FDA General

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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>FDA's Revolving Door; 2.4 Million Excess Deaths; Can Anorexia Be 'Terminal'?

Health news and commentary from around the Web gathered by 乌鸦传媒 staff

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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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Draft guidance explains what doesn't qualify as "scientifically sound" information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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>Probiotics for Preterm Infants Could Pose Serious Danger, FDA Warns

Abbott, Infinant Health sent warning letters about their products

The advertisement for this Instagram Live event.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>Suzanne Somers Dies; FDA Plans to Ban Hair Relaxers; Health Worker Minimum Wage

Health news and commentary from around the Web gathered by 乌鸦传媒 staff

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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>A Framework to Communicate With Pregnant Patients About the RSV Vaccine

A values-based decision-making framework is key

FDA MARKETING Invitae Common Hereditary Cancers Panel over a photo of the product.

<乌鸦传媒>FDA Greenlights Test for Cancer-Predisposing Genetic Mutations

First-of-its-kind DNA test achieved 99% accuracy for variants in dozens of genes

FDA APPROVED nedosiran (Rivfloza) over a computer rendering of a transparent kidney with kidney stones.

<乌鸦传媒>FDA OKs Another Injectable for Rare Kidney Disorder

Nedosiran approved for patients ages 9 years and older with primary hyperoxaluria type 1

A photo of a female lab technician preparing samples for PCR diagnostics

<乌鸦传媒>Lab Tests That Escape FDA Oversight May Come Under Agency Review

Agency proposes tighter oversight of laboratory developed tests

FDA APPROVED cipaglucosidase alfa (Pombiliti) plus miglustat (Opfolda) over a muscle biopsy showing accumulation of glycogen.

<乌鸦传媒>New Option OK'd for Pompe Disease

FDA approves two-component therapy for patients not improving on enzyme replacement therapy

FDA APPROVED gepirone hydrochloride extended-release (Exxua) over a photo of a woman covering her face with her hands.

<乌鸦传媒>FDA Relents, Approves Novel Antidepressant After Many Rejections

Gepirone extended-release approved after nearly 2 decades of trying

A photo of an Ozempic injection pen laying on a marble countertop.

<乌鸦传媒>FDA Adds Intestinal Blockage Reports to Ozempic Labeling

Joins other approved GLP-1 receptor agonists in noting the potential adverse reaction

FDA ADCOMM debamestrocel (NurOwn) over a computer rendering of a damaged neuron.

<乌鸦传媒>FDA Panel Overwhelmingly Rejects ALS Cell Therapy

Echoing concerns from agency reviewers, advisors can't find evidence of efficacy

A photo of the US Capitol building in Washington DC.

<乌鸦传媒>With Shutdown Likely, Policy Experts Weigh Health Risks

Food safety, innovation, and community health centers all could see trickle-down effects

A photo of a wooden scoop laying in a pile of sesame seeds.

<乌鸦传媒>FDA Displeased With Companies Purposely Adding Sesame to More Foods

Agency issues updated guidance for limiting cross-contamination in wake of FASTER act

FDA APPROVED phentolamine ophthalmic solution (Ryzumvi) over a photo of an eye affected by mydriasis

<乌鸦传媒>Mydriasis-Reversing Eye Drops Win FDA Approval

Pupil diameter normalized significantly faster with phentolamine solution in phase III trials

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