番茄社区app

Public Health & Policy >

FDA General

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

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.

Heavy Metal in Chocolate; Trump 'No Doubt' Hit By Bullet; FDA Cinnamon Warning Grows

Health news and commentary gathered by 番茄社区app staff

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

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.

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.

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.

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.

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.

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.

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.

'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.

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.

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.

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).

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

Docs in Abortion Ban States Find Workarounds to Deliver Care

A 番茄社区app 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.

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.

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.

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

Tech in Diabetes: What's Going Wrong?

FDA Commissioner Robert Califf, MD, talks tech

FDA MARKETING Menthol-flavored e-cigarette products (NJOY) over a photo of two NJOY menthol products.

FDA Authorizes First Menthol E-Cigarettes

Meanwhile, HHS still has not issued a final rule banning menthol-flavored tobacco cigarettes

A photo of a lab technician preparing umbilical cord tissue samples.

FDA Warns Yet Another Birth Tissue Company

Agency says Neobiosis amniotic fluid, umbilical cord products should be regulated as drugs

FDA delandistrogene moxeparvovec-rokl (Elevidys) over an image dystrophin in Duchenne muscular dystrophy muscle cells.

Gene Therapy for Duchenne Muscular Dystrophy Gets Expanded Approval

Primary endpoint wasn't met, but other outcomes provided "substantial evidence of effectiveness"

A computer rendering of two monoclonal antibodies of different coloration.

FDA Plans to Ease Requirements for Biosimilars' Interchangeable Status

New rules would mean switching studies will generally not be needed

FDA APPROVED sofpironium (Sofdra) over a photo of a sweat stain on the armpit of a t-shirt

Topical Agent for Hyperhidrosis Wins FDA Approval

Sofpironium gel meets all primary and secondary endpoints in two vehicle-controlled trials

An illustration of Out of Stock notices on pharmacy shelves

Drug Shortages Keep Growing. Older, Injectable Agents Are Among the Most Vulnerable.

A Q&A with Erin Fox, PharmD, MHA, on the record-breaking shortages

FDA APPROVED Pneumococcal 21-valent Conjugate Vaccine (Capvaxive) over a computer rendering of pneumococcal pneumonia

FDA Approves Pneumococcal Vax Designed Specifically for Adults

Covers serotypes responsible for over 80% of invasive pneumococcal disease in those 50 and up

FDA APPROVED durvalumab (Imfinzi), pembrolizumab (Keytruda) over an illustration of endometrial cancer.

Two New Immunotherapy-Chemo Options Approved for Endometrial Cancer

New indications for pembrolizumab and durvalumab in advanced disease

A photo of a court exhibit on the laptop of Brenna Bird in Urbandale, Iowa.

Some Hawking Stem Cells Say They Can Treat Almost Anything. They Can't.

Attorneys general in several states have sued businesses for false claims

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

Secret Pentagon Anti-Vax Campaign; FDA's Tylenol Warning; E. Coli at the Olympics

Health news and commentary gathered by 番茄社区app staff

A photo of the offices of the Heritage Foundation in Washington, D.C.

The Next Big Challenges for Medication Abortion

Anti-abortion states continue to fight; a possible Trump victory opens door to new strategies

5

鈥�