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FDA General

A female physician fits a blood pressure cuff onto the arm of a man with down syndrome

Are We Equipped to Care for People With Intellectual, Developmental Disabilities?

Low accreditation standards are contributing to health disparities

FDA APPROVED abrocitinib (Cibinqo), upadacitinib (Rinvoq) over a photo of a persons hands with atopic dermatitis

FDA OKs Two Oral JAK Inhibitors for Refractory Atopic Dermatitis

Once-daily abrocitinib and upadacitinib join topical ruxolitinib in expanding AD market

A bottle of Gleevec next to a bottle of generic Imatinib Mesylate Tablets

Growing Controversy Over 'Skinny' Labeling for Generic Drugs

What's at stake in legal battles over patent-avoiding approval pathway for generics

UK public advertising campaign posters which read: GET BOOSTED NOW

(When) to Boost or Not to Boost, That Is the Question

Countless complex questions remain

A portrait of a male physician covering his mouth.

Why Are Physicians Silent About Outrageous Drug Prices?

Milton Packer wonders why physicians are struggling to get their priorities straight

A female healthcare worker in full protective gear holds a swab to the camera in her blue rubber gloved hand

Nose or Throat: What鈥檚 Best for a COVID Test?

Early data support saliva testing, but it might be too early to tell

A photo of stretch marks called striae seen in a patient with Cushing鈥檚 syndrome

FDA OKs Endogenous Cushing's Syndrome Treatment

Recorlev reduced and normalized cortisol levels in clinical studies

An illustration depicting Alzheimer鈥檚 disease with amyloid plaques forming between neurons

Alzheimer's Drugs Race to FDA

After aducanumab, drug companies pivot to use the accelerated approval pathway

A healthcare worker in full protective gear holds a vial of the Novavax vaccine in their blue rubber gloved hand

What Happened to the Novavax Vaccine?

As mRNA vaccines saturate the U.S. market, is there room for another?

A close up shot of a nurse鈥檚 blue rubber gloved hand about to drop a vial of morphine sulfate into a pocket of their scrubs

'Pending Wave' of Nurse Substance Use Problems?

Signs point to deepening issue with alcohol, drugs as nurses battle through the pandemic

A bottle of Fluvoxamine Maleate tablets over a computer rendering of COVID viruses

Doctor Submits Fluvoxamine EUA Application to FDA

Group of physician-scientists believes data support authorization for treating COVID-19

FDA APPROVED tralokinumab (Adbry) over a photo of a patients hand with atopic dermatitis held by a doctors blue gloved hand.

IL-13 Inhibitor Approved for Adults With Atopic Dermatitis

Significantly greater lesion clearance with tralokinumab in placebo-controlled studies

FDA APPROVED cabotegravir (Apretude) over a photo of a syringe drawing from a vial

FDA Approves First Long-Acting Injectable to Prevent HIV Infection

Apretude is administered every 2 months versus a daily pill

FDA APPROVED efgartigimod (Vyvgart) over an illustration of a normal nerve and a nerve affected by myasthenia gravis

Novel Myasthenia Gravis Treatment Wins FDA Nod

Efgartigimod is the first approved FcRn blocker

An illustration of a woman standing between a doctor and patient, their words going through her head.

Medical Translation Sacrifices Accuracy for Understanding

In health facilities and the pharmaceutical industry, this has consequences for patients

A woman鈥檚 hand holding a Mifeprex tablet above the box with a jar of cotton swabs in the background.

FDA Relaxes Restrictions on Abortion Pill

Federal government permanently removes requirements that patients pick up mifepristone in person

ASHP over a close up of pills being counted in a pharmacy

U.S. Dragging Its Feet on Biosimilar Approvals, Pharmacist Says

Introduction of biosimilars falling behind that of other countries

ASHP over a close up of pills being counted in a pharmacy

The ASHP Wants to Stop White Bagging on Prescription Drugs

This practice "jeopardizes patient care," says ASHP official

A photo of Merck鈥檚 Molnupiravir bottle and capsules.

Getting COVID Antiviral Pills Into Patients' Hands

Here's how to foster equal access to two treatments that may soon be authorized

A colorful abstract illustration of a human brain and head silhouette and the cosmos.

Is Psychedelic Research Funding Starting to Shift?

Once the province of philanthropy, industry and government sources show interest

FDA APPROVED vosoritide (Voxzogo) over a photo of a young boy with dwarfism laying on the floor coloring.

FDA OKs First Drug for Most Common Form of Dwarfism

Mixed reactions follow new treatment for children 5 and up with open growth plates

A single dose of Suboxone lies next to a spoon and syringes

Buprenorphine Misuse: What's the Reality?

New study highlights need to expand access to buprenorphine for OUD

A computer rendering of a fetus in utero.

Preterm Birth Drug Tied to Cancer Risk in Those Exposed in Utero

Mothers who took 17-OHPC for miscarriage in the 1950s and 1960s had offspring at greater risk

Experts Blow Whistle on Alleged COVID Vaccine Whistleblower Claims

Allegations described as "vague kind of hand waving"

FDA ADCOMM over a photo of a teen girl wincing as she takes a dose of nasal spray.

FDA Panel Shows Little Love for Prader-Willi Drug Candidate

All but one committee member said phase III evidence for carbetocin nasal spray was insufficient

A child wearing a protective mask holds a COVID-19 Vaccination Record Card showing a dose of the Pfizer vaccine.

What You Need to Know About Kids' COVID Vax Dose

Lower dose showed good antibody response, low side effects

FDA APPROVED asciminib (Scemblix) over a microscopy of chronic myeloid leukemia

FDA Approves STAMP Inhibitor for Chronic Myeloid Leukemia

Patients treated with two or more TKIs and those with T315I mutation gain new option

A computer rendering of arrows colliding with a brick wall, one reverses, one is stopped, one breaks through.

Reversal, Replacement, and Reassessment in Medicine

Three ways medical science progresses and what this has to do with aspirin

A BinaxNOW COVID-19 rapid antigen test on the shelf at a pharmacy

What's Driving the COVID Rapid Test Shortage?

Demand from employers is surging, and so are prices

A photo of five beagle puppies.

Fauci Blasted Over Puppy Research Claims

Conservative watchdog group unleashes outrage over Beagle studies

FDA APPROVED Susvimo over a computer rendering of a syringe delivering an injection to an eye.

Continuous-Release Anti-VEGF Device for AMD Wins FDA Approval

Susvimo ocular implant with 6-month refill proved equivalent to monthly eye injections

A photo of Robert Califf, MD, MACC

Tread Carefully in Choosing the Next FDA Leader

The potential re-appointment of Robert Califf as commissioner is cause for concern

FDA to Make Isotretinoin Prescribing Gender Neutral

Revision to risk management program dissociates gender from reproductive categories

Two tablets and a capsule cover Benjamin Franklin鈥檚 eyes and mouth on a $100 bill.

The Price Tag of FDA's 'Onco-Exceptionalism'

Substantial use of certain cancer drugs without an overall survival benefit

FDA APPROVED adalimumab-adbm (Cyltezo) over a photo of a woman using an auto injector syringe.

First Interchangeable Humira Biosimilar Approved

Cyltezo nabs coveted "interchangeable" status for RA, inflammatory bowel disease, and more

A close up of a COVID-19 Vaccination Record Card in a man鈥檚 hand which shows he鈥檚 received a Pfizer booster shot

To Boost or Not to Boost After COVID?

In those with "hybrid immunity," booster could be helpful but probably not necessary, experts say

FDA GUIDANCE Sodium over a photo of a spilled salt shaker

FDA Nudges Restaurants, Food Manufacturers to Cut Sodium

Voluntary guidance aims to reduce Americans' sodium intake by 12%

FDA WARNING Needle-Free Devices for Injection of Dermal Fillers over a photo of a woman receiving lip filler via hyaluron pe

FDA Warns on Needle-Free Injection Devices for Facial Fillers

Serious injuries and "irreversible" harm to skin, lips, and eyes reported with unapproved devices

FDA APPROVED avacopan (Tavneos) over a photo of a man鈥檚 foot showing vasculitis.

FDA Gives Thumbs Up to ANCA-Associated Vasculitis Drug

Approval granted to avacopan despite advisory committee concerns

A photo of the Medtronic 670G insulin pump

Back-to-Back Recalls for Medtronic Insulin Pumps

Class I recalls on 600 series pumps and 500 series remotes

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