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FDA General

FDA ACTION midomafetamine (MDMA) over a photo of medication capsules.

<乌鸦传媒>FDA Rejects MDMA-Assisted Therapy for PTSD

Decision largely expected after agency advisors voted against psychedelic's safety and efficacy

FDA APPROVED epinephrine nasal spray (neffy) over a photo of the product.

<乌鸦传媒>FDA Approves First Emergency Allergy Nasal Spray

Neffy is a non-needle-based epinephrine treatment for anaphylaxis and other allergic reactions

FDA APPROVED carbidopa and levodopa (Crexont) over an image the substantia nigra and a neuron containing Lewy bodies.

<乌鸦传媒>New Extended-Release Parkinson's Drug Approved

Novel levodopa and carbidopa formulation led to more time without troublesome dyskinesia

FDA APPROVED denileukin diftitox (Lymphir) over a photo of cutaneous T-cell lymphoma.

<乌鸦传媒>IL-2 Receptor-Targeted Therapy Approved for Relapsed/Refractory CTCL

New iteration of denileukin diftitox led to objective responses in 36% of pretreated patients

FDA APPROVED iptacopan (Fabhalta) over a computer rendering of a transparent body with a kidney highlighted.

<乌鸦传媒>FDA OKs Complement Inhibitor for IgA Nephropathy

First-in-class iptacopan approved to reduce proteinuria in adults with rare progressive disease

FDA APPROVED vorasidenib (Voranigo) over a computer rendering of a brain tumor.

<乌鸦传媒>FDA Approves Vorasidenib for IDH-Mutant Gliomas

Treatment improved PFS by 16 months compared with placebo in INDIGO trial

A photo of packages of Plant Based Organic Burger Patties for sale in a supermarket.

<乌鸦传媒>Plant-based Food and Drink Labeling Is a Battlefield

Public health considerations are missing in action

A photo of a woman visiting an online pharmacy.

<乌鸦传媒>Prescription-Free Online Semaglutide Is Risky Business

Over 40% of pharmacy sites offering GLP-1 drug without a script are known to operate illegally

FDA ADCOMM arimoclomol over a computer rendering of a strand of DNA.

<乌鸦传媒>FDA Advisors Mostly Convinced Arimoclomol Works for Rare Genetic Disorder

If approved, this would be the first drug for Niemann-Pick disease type C

FDA APPROVED afamitresgene autoleucel (afami-cel, Tecelra) over a computer rendering of a tumor.

<乌鸦传媒>FDA Greenlights First Engineered Cell Therapy for a Solid Tumor

Afamitresgene autoleucel (Tecelra) approved for metastatic synovial sarcoma

FDA ADCOMM arimoclomol over a computer rendering of a strand of DNA.

<乌鸦传媒>FDA Panel to Consider Arimoclomol for Rare Genetic Disorder

This is the second time the drug has been submitted to the FDA for Niemann-Pick disease type C

FDA APPROVED daratumumab-hyaluronidase (Darzalex Faspro), bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone

<乌鸦传媒>FDA OKs Subcutaneous Daratumumab Plus VRd for Myeloma

Indicated for newly diagnosed patients who are eligible for stem cell transplant

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

<乌鸦传媒>Heavy Metal in Chocolate; Trump 'No Doubt' Hit By Bullet; FDA Cinnamon Warning Grows

Health news and commentary gathered by 乌鸦传媒 staff

FDA APPROVED benzgalantamine (Zunveyl) over a computer rendering of nerve cells affected by Alzheimer鈥檚 disease.

<乌鸦传媒>Alzheimer's Gets New Galantamine Drug

Newly approved prodrug has dual mechanism of action to improve tolerability

A photo of a syringe resting on the lid of a glass vial.

<乌鸦传媒>FDA Warns of Overdoses With Compounded Semaglutide

Multi-dose vials pose complications for self-administration

FDA APPROVED paliperidone palmitate (Erzofri) over a computer rendering of electrical impulses in the brain.

<乌鸦传媒>New Monthly Paliperidone Palmitate Injectable OK'd for Schizophrenia

Long-acting intramuscular product approved for schizoaffective disorder as well

FDA APPROVED Blood test for colorectal cancer (Shield) over a photo of the product.

<乌鸦传媒>FDA Approves Blood Test for Colon Cancer Screening

Shield becomes the first liquid biopsy for primary CRC screening

A photo of U.S. Army veteran Casey Tylek at his home in Leominster, Massachusetts.

<乌鸦传媒>Veterans Lobby for Psychedelic Therapy, but Will It Influence MDMA's Approval?

Hurdles remain for FDA application

deuruxolitinib (Leqselvi) over a photo of a woman with severe alopecia.

<乌鸦传媒>Third JAK Inhibitor for Alopecia Areata Wins FDA Approval

Over 30% of patients had at least 80% scalp hair regrowth with deuruxolitinib

FDA ODAC durvalumab (Imfinzi) over a computer rendering of an antibody attacking lung cancer cells.

<乌鸦传媒>FDA Panel Supports More Clarity in NSCLC Perioperative Immunotherapy Trials

Committee unanimously backs mandating trial design to distinguish effects of therapy phases

INVESTIGATIVE ROUNDUP over an image of two people looking at computer screens.

<乌鸦传媒>'Shambolic' Medical Meeting; DaVita Whistleblower Suit; FDA Mum on MDMA

This past week in healthcare investigations

FDA APPROVED norethindrone acetate and ethinyl estradiol (Femlyv) over a photo of a woman about to take a tablet.

<乌鸦传媒>FDA OKs First Orally Dissolving Birth Control Pill

Opens up options for people who have trouble swallowing

A photo of Donald Trump at the Republican National Convention in Milwaukee.

<乌鸦传媒>Trump Talks Cancer Cures, 'Right to Try' as He Accepts GOP Presidential Nomination

"We're going to get to the bottom of it"

A computer rendering of the packaging for the Vuse Alto e-cigarette.

<乌鸦传媒>FDA Allows Best-Selling E-Cigarette Vuse Alto, but Only in Tobacco Flavor

Agency previously rejected the company's menthol-flavored products

A computer rendering of the Susvimo ocular implant (Susvimo).

<乌鸦传媒>Anti-VEGF Ocular Implant for Age-Related Macular Degeneration to Return to Market

Updates to device, refill syringe, manufacturing process restore function to expected level

A photo of the Supreme Court building in Washington DC.

<乌鸦传媒>With the End of Chevron, Health and Environmental Experts' Hands Are Tied

We need the rule of law to protect public health

A computer rendering of an oligonucleotide aptamer attacking a cancer cell.

<乌鸦传媒>Can Oligonucleotide Infusions Really Fix Lyme, Cancer, and Other Diseases?

U.S. clinics market oligonucleotide therapy for a wide range of conditions, without much evidence

A photo of the Supreme Court building.

<乌鸦传媒>Supreme Court to Weigh if FDA Was Heavy-Handed With Its Flavored E-Cig Regulations

Agency is appealing a lower court ruling siding with vaping companies

FDA APPROVED donanemab (Kisunla) over a computer rendering of amyloid plaques forming between neurons.

<乌鸦传媒>FDA OKs Another Drug for Early Alzheimer's Disease

Decision gives patients a second anti-amyloid treatment option

A photo of the Supreme Court building under a cloudy sky.

<乌鸦传媒>Supreme Court Decision May Have Sweeping Effects on Healthcare, Experts Say

Chevron ruling curbs federal power, could upend drug approvals, Medicare drug price negotiation

A photo of the Longworth House Office Building in Washington, DC

<乌鸦传媒>House Panel OKs Bills on Obesity Drug and Breakthrough Device Coverage in Medicare

Meanwhile, CMS proposed rule on the device coverage, issued a year ago, awaits a final version

FDA MARKETING Hepatitis C RNA Test (Xpert HCV test + GeneXpert Xpress System) over a photo of the devices.

<乌鸦传媒>FDA OKs First Point-of-Care Test for Detecting Hep C in At-Risk Adults

Results as quick as 1 hour, enabling a test-and-treat approach

A photo of a surgeon removing the cornea from a donor.

<乌鸦传媒>FDA Warns Eye Bank for Taking Donors Who Had Sepsis

All five donors should have been ineligible, FDA said

FDA APPROVED ensifentrine (Ohtuvayre) over a computer rendering of transparent lungs.

<乌鸦传媒>FDA Approves Novel Nebulized Therapy for COPD

First-in-class dual phosphodiesterase inhibitor lands broad indication for COPD maintenance

A photo of a female technician preparing a chemotherapy treatment in a glove box.

<乌鸦传媒>Oncology Drug Shortages Persist, but Continue to Evolve

Supply-chain issues, unrealistically low prices for generics, hoarding, other factors to blame

A photo of a vacant examination room of an obstetrics and gynecology clinic.

<乌鸦传媒>Docs in Abortion Ban States Find Workarounds to Deliver Care

A 乌鸦传媒 survey reveals surprising trends in reproductive care 2 years post-Roe

FDA APPROVED crovalimab (Piasky) over a computer rendering of blood flowing inside a vessel.

<乌鸦传媒>Subcutaneous C5 Inhibitor Approved for PNH

Longer-acting crovalimab designed for more sustained effect and less treatment burden

FDA APPROVED efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) over a computer rendering of a neuron.

<乌鸦传媒>New Treatment Approved for Chronic Inflammatory Demyelinating Polyneuropathy

Efgartigimod injection reduced CIDP relapse risk

FDA APPROVED adagrasib (Krazati) over a computer rendering of colorectal cancer.

<乌鸦传媒>Adagrasib Wins Accelerated Approval for KRAS-Mutant Colorectal Cancer

KRAS inhibitor plus cetuximab achieved 34% response rate, 85% disease control in early trial

ADA over a photo of the Ernest N. Morial Convention Center in New Orleans, LA

<乌鸦传媒>Tech in Diabetes: What's Going Wrong?

FDA Commissioner Robert Califf, MD, talks tech

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