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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 榴莲视频 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 榴莲视频 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

A photo of signage outside Abbott Laboratories in Lake Forest, Illinois.

FDA Took Months to React to Complaint About Abbott's Formula Factory, Audit Finds

Several infants were hospitalized, and two died

A photo of bottles of Adderall tablets on the shelf in a pharmacy.

CDC Warns of Risks for ADHD Patients After Disruption of Online Adderall Prescriber

Agency advises users of telehealth platform Done Global to find a new provider

A photo of the packaging and blisterpack of mifepristone (Mifeprex).

Health Groups, Others React to SCOTUS Decision on Mifepristone

But the battle over abortion is far from over, they say

A photo of an open tanning bed.

Tanning Salons Are Overdue for a Regulatory Burn

In the meantime, don't forget to educate patients on the risks

A computer rendering of CAR T cell therapy in Diffuse large B-cell lymphoma

New Clues to Origin of T-Cell Lymphoma After CAR-T Therapy

Co-mutations, viral link, potential common susceptibility emerge from two studies

A photo of Dick Durbin speaking during a hearing on combating the rise of illegal electronic cigarettes.

Senators Blast Health and Law Enforcement Officials Over Illegal E-Cig Use in Teens

The two best-selling disposable vapes alone generated more than $500 million in sales last year

A photo of an avian influenza antigen rapid test kit.

With Bird Flu Tests Hard to Get, How Will We Know When to Sound a Pandemic Alarm?

If government doesn't prepare to ramp up testing, U.S. could be caught off guard again

A photo of signage outside of FDA headquarters in Silver Spring, Maryland.

Was the FDA Panel Right to Recommend Against MDMA Approval?

Psychedelic treatments have potential, and taking an evidence-based approach is what's needed

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