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FDA General

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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>Secret Pentagon Anti-Vax Campaign; FDA's Tylenol Warning; E. Coli at the Olympics

Health news and commentary gathered by 乌鸦传媒 staff

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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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).

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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 signage outside of FDA headquarters in Silver Spring, Maryland.

<乌鸦传媒>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.

<乌鸦传媒>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 鈥渕other鈥� shells in Willapa Bay near Tokeland, Washington.

<乌鸦传媒>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鈥檚 disease.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>'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

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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鈥檚 disease.

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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!

<乌鸦传媒>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

<乌鸦传媒>FDA Panel Votes Against MDMA for PTSD

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

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

<乌鸦传媒>FDA Panel to Consider Which COVID Strain to Target in an Updated Vaccine

The KP.2 subvariant is now dominant in the U.S., FDA staff says in a briefing document

A photo of two male farmers talking in a dairy cow barn.

<乌鸦传媒>'Uncertainty' Isn't a Bad Word: U.S. Agencies Must Tighten Up H5N1 Communications

More effective and efficient public messaging is the need of the hour

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

<乌鸦传媒>FDA Staff Questions Safety of MDMA Treatment for PTSD

Advisory committee will weigh benefits and risks next week

FDA APPROVED mRNA-1345 vaccine (mRESVIA) over a computer rendering of respiratory syncytial viruses.

<乌鸦传媒>FDA Approves First mRNA RSV Vaccine

Moderna vaccine indicated for people ages 60 and up

A photo of a female lab technician using a pipette to transfer material.

<乌鸦传媒>Company Warned Over Atypical Fat-Derived Stem Cell Product

Stromal vascular fraction isn't usually sourced from donors

A photo of donor cornea for transplant.

<乌鸦传媒>FDA Urged to Relax Tissue Donation Restrictions for Gay, Bisexual Men

Advocates say policy should be based on individualized risk assessments, "not historic bias"

FDA ADCOMM insulin icodec (Awiqli) over a photo of a man holding an injection pen to his stomach.

<乌鸦传媒>FDA Advisors Not Convinced Once-Weekly Insulin Is Safe in Type 1 Diabetes

Risk of severe hypoglycemia was too much for panel members to overcome

FDA ADCOMM Blood-based colorectal cancer test (Shield) over a photo of the product.

<乌鸦传媒>Blood Test for Colon Cancer Screening Secures FDA Panel's Blessing

But advisors urge strong labeling emphasizing Shield test's low sensitivity for advanced adenomas

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