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FDA General

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 MedPage Today 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 MedPage Today 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

FDA APPROVED oral elafibranor (Iqirvo) over a computer rendering of a diseased liver.

Novel Drug for Rare Chronic Liver Disease Wins Conditional FDA Approval

First-in-class PPAR agonist led to biochemical responses in more than 50% of patients in trial

A photo of grasses and yearling oysters growing on the large “mother” shells in Willapa Bay near Tokeland, Washington.

What to Know About FDA's Warning on Paralytic Shellfish Poisonings

At least 31 people have been sickened in Oregon from eating shellfish harvested in the area

FDA ADCOMM donanemab over a computer rendering of neurons affected by Alzheimer’s disease.

Unanimous Thumbs-Up From FDA Advisors for Alzheimer's Drug

Advisory committee decision smooths the way for eventual FDA approval

FDA APPROVED RSV prefusion F protein-based vaccine (Arexvy) over a microscope image of respiratory syncytial viruses.

FDA Expands Use of RSV Vaccine to Include More Adults

Arexvy now approved for people 50 years and older at increased risk of serious outcomes

A photo of Covid Task Force Ambassador Deborah Birx speaking during the covid pandemic.

'Uncertainty' Is Indeed a Bad Word: A Second Opinion on Pandemic Communication

Information should be presented to the public using a three-part approach

Lawrence O. Gostin, JD, LLD, and Sarah Wetter, JD, MPH

Here Are the Top Supreme Court Health Cases to Watch

A slew of cases this term could reshape health policy

NYV over a photo of Jacob K. Javits Convention Center in New York City, NY

New Tricuspid Interventions Launched into 'Broken' System

Having the technology reach the right patients is a major challenge in the real world

FDA APPROVED imetelstat (Rytelo) over a photo of a bag of blood in blue rubber gloved hands.

Telomerase Inhibitor Approved for MDS-Related Anemia

Imetelstat indicated for lower-risk myelodysplastic syndromes with transfusion-dependent anemia

FDA ADCOMM donanemab over a computer rendering of neurons affected by Alzheimer’s disease.

FDA Reviewers Question Patient Selection for Alzheimer's Drug Candidate

Agency's advisors will discuss efficacy, safety of investigational donanemab

NYV over a photo of Jacob K. Javits Convention Center in New York City, NY

Can Mitral Valve Innovators Dig Themselves Out of a Rut?

Current transcatheter mitral valve replacement devices a poor match for clinical need

FDA MARKETING JUUL over a photo of the product.

Juul Vaping Products' Stay of Execution Is Now More Official

FDA rescinds marketing denials pending further review

FDA ADCOMM 2024-2025 formula for COVID-19 vaccines over a photo of a syringe drawing from a vial.

FDA Advisors Give a Hearty Thumbs Up to a COVID Vaccine Based on the JN.1 Strain

"Even with some variation, there's still reasonably good protection"

A graphic from Safari Regenerative Therapy which reads: Get Over It! Stem Cells Work!

FDA Warns Company Making Stem Cell Products for Pets

Safari Stem Cell claims its products can treat a range of animal diseases, FDA says

FDA ADCOMM midomafetamine capsules (MDMA, Lykos Therapeutics) over a close up photo of drug capsules

FDA Panel Votes Against MDMA for PTSD

Advisors raised concerns about efficacy, safety, trial design, misconduct

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