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FDA General

FDA APPROVED testosterone undecanoate (TLANDO) over a man holding a white pill between his fingers and a glass of water.

Another Oral Testosterone Undecanoate OK'd for Hypogonadism

FDA approval of Tlando follows in the footsteps of Jatenzo

FDA APPROVED nivolumab and relatlimab-rmbw (Opdualag) over a computer rendering of a skin cross-section with melanoma.

Novel Fixed-Dose Immunotherapy Combo Wins FDA Approval

Nivolumab plus relatlimab doubled progression-free survival in unresectable melanoma

Blue rubber gloved hands holding a vial of umbilical cord stem cells.

Medicare Claws Back Money for Dubious Birth-Tissue Stem Cell Shots

Government seeks to recoup more than 2 years of payments for unproven treatments

FDA APPROVED Generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol with woman using inhaler.

First Generic OK'd for Popular Asthma, COPD Inhaler

FDA approves Mylan's Symbicort copy, reflecting agency's commitment to "increase competition"

FDA WARNING Renuvion/J-Plasma Device over photos of the device.

FDA Warns on Using Surgical Device for Aesthetic Skin Procedures

Agency details potentially life-threatening adverse events with plasma-generating device

FDA APPROVED olaparib (Lynparza) over a computer rendering of a tumor in a woman鈥檚 transparent breast

FDA OKs PARP Inhibitor as Adjuvant Therapy in Early Breast Cancer

Olaparib (Lynparza) approved for high-risk patients with germline BRCA mutations

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

Rare Vaccine Death; Vape Loophole Exploited; No Paxlovid for the Imprisoned

This past week in healthcare investigations

A computer rendering of a man in a suit looking at a document while standing on top of and surrounded by tall stacks of paper

FDA Begins Releasing Pfizer COVID Vax Documents

Court-ordered release runs risk of "cherry picking and taking things out of context"

A photo of a bottle of Dr. Bronner鈥檚 Pure-Castile Soap next to a bath scrubber.

Dr. Bronner's Offering Its Workers Psychedelic Therapy Coverage

Soap company to cover ketamine-assisted therapy for employees with new industry nonprofit

A photo of a nurse's blue rubber gloved hand touching an IV drip bag in a hospital room

Thumbs Down for IV Tramadol, FDA Advisers Say

Delayed onset of pain relief remains a concern

A hand holding Senseonics continuous glucose monitor Eversense.

FDA OKs 180-Day Implantable Continuous Glucose Monitor

Senseonics' Eversense E3 System approved for adults with diabetes

FDA SAFETY enteral feeding tubes over a photo of enteral feeding tubing, syringes, and jars of formula.

FDA Warns of Strangulation Risk for Kids on Feeding Tubes

Two toddlers died after being found with enteral feeding systems' tubing around their necks

FDA SAFETY over a photo of a bottle of Ukoniq tablets.

FDA Concerned About Safety of Lymphoma Drug

Hint of excess mortality in trial of umbralisib/ublituximab prompts public notice

FDA APPROVED cyclosporine ophthalmic emulsion (Restasis) generic over a photo of a woman using eye drops

FDA Approves First Generic of Restasis for Dry Eye

A new option for those affected by keratoconjunctivitis sicca

FDA APPROVED Moderna COVID vaccine (Spikevax) over a photo of a vial of Spikevax

Another COVID Vaccine Garners Full FDA Approval

Moderna's Spikevax approved for adults ages 18 and up

A photo of boxes of Veklury

Remdesivir Now Approved for COVID Outpatients, Too

FDA expands indication of Veklury to bolster supply of treatment during Omicron surge

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

Too Much Focus on Boosters, Says FDA Vaccine Advisor

At the hospital level, COVID-19 remains "a disease for the unvaccinated," says Paul Offit, MD

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 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 inclisiran (Leqvio) over a computer rendering of an LDL cholesterol molecule.

FDA Approves Cholesterol-Lowering siRNA Therapy

PCSK9 inhibitor inclisiran to become available in early 2022

FDA EUA nirmatrelvir/ritonavir (Paxlovid) over a photo of a box of Paxlovid

FDA: The Wait for COVID Pills Is Over

Paxlovid first oral antiviral authorized to treat high-risk COVID patients

FDA APPROVED CavaClear Laser Sheath over an illustration of the placement of an IVC filter

FDA OKs Laser-Assisted IVC Filter Removal

Another option for hard-to-remove filters

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

A pain scale chart over a photo of a large white capsule laying on other capsules.

Is 'Big Pharma' To Blame For the Opioid Crisis?

More complex and actionable issues are at the root of the problem

A computer rendering of the Alterra pre-stent and the Sapien 3 transcatheter pulmonic valve replacement

Sapien 3 With Pre-Stent Gets FDA Go-Ahead for Pulmonary Valve Fix

Valve system could substantially expand proportion of patients who can skip another surgery

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

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

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