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FDA General

FDA APPROVED ciltacabtagene autoleucel (Carvykti), idecabtagene vicleucel (Abecma) over 3D multiple myeloma cells.

<乌鸦传媒>FDA Approves Earlier Use of CAR-T Products for Myeloma

Carvykti and Abecma move to second- and third-line, respectively

A close up photo of two Wegovy injection pens.

<乌鸦传媒>Medicare Can Cover Anti-Obesity Drugs for Heart Disease -- But at What Cost?

Intense demand coupled with high costs may place pressures on CMS for years to come

AACR over a photo of San Diego Convention Center in San Diego, CA

<乌鸦传媒>Most Cancer Drugs Granted Accelerated Approval Fail Confirmatory Trials

Only 43% showed clinical benefit within 5 years

FDA APPROVED trastuzumab deruxtecan (Enhertu) over a computer rendering of antibodies attacking cancer cells

<乌鸦传媒>Enhertu Gets Tumor-Agnostic FDA Approval for HER2-Positive Cancers

About half of patients responded, duration of response as long as 19 months in three trials

Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.

<乌鸦传媒>More Bird Flu Spread; FDA to Allow Gay Men to Donate Sperm; 'Oatzempic' Trend

Health news and commentary from around the Web gathered by 乌鸦传媒 staff

A photo of the AvertD test kit.

<乌鸦传媒>Genetic Test for Opioid Addiction Risk Should Be Withdrawn, Experts Tell FDA

Methodology behind AvertD DNA test questioned

A photo of a box of taurursodiol (Relyvrio)

<乌鸦传媒>ALS Therapy to Be Pulled From the Market, Drugmaker Says

Patients currently using Relyvrio can transition to a free drug program, Amylyx said

FDA APPROVED danicopan (Voydeya) over a computer rendering of red blood cells.

<乌鸦传媒>Factor D Inhibitor Wins Approval for PNH With Extravascular Hemolysis

Danicopan significantly improved hemoglobin at 12 weeks when added to a C5 inhibitor

FDA APPROVED ceftobiprole medocaril sodium (Zevtera) over a computer rendering of Staphylococcus aureus bacteria

<乌鸦传媒>FDA OKs Injectable Antibiotic for Three Different Uses

Ceftobiprole was at least comparable to currently used medications in studies

A photo of a man鈥檚 arm with an intravenous line attached dangling off the edge of a couch.

<乌鸦传媒>Are Federal Agencies Coming for Ketamine Clinics?

Compliance plans can help in the face of possible regulatory scrutiny

Photo of a man with a continuous glucose monitor on his arm.

<乌鸦传媒>Here's What OTC Continuous Glucose Monitors Can Do for Our Patients

FDA's approval may be a step toward greater access

FDA APPROVED sotatercept (Winrevair) over computed tomography angiography of the pulmonary arteries

<乌鸦传媒>Sotatercept's FDA Approval a New Chapter for Pulmonary Arterial Hypertension

Biologic should arrive on pharmacy shelves before May

Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.

<乌鸦传媒>FDA Questioned on Elon Musk's Neuralink; OTC Pain Relief Warning; Easter Egg Safety

Health news and commentary from around the Web gathered by 乌鸦传媒 staff

A photo of a vial of Fluorouracil

<乌鸦传媒>Overdosing on Chemo: A Common Gene Test Could Save Hundreds of Lives Each Year

Treatment can be deadly for enzyme-deficient patients; NCCN doesn't call for preemptive testing

A photo of the electrodes of an Electrical Stimulation Device

<乌鸦传媒>FDA Again Tries to Ban 'Aversive' Shock Treatment

Agency proposed a new ban to eliminate shock therapy for self-injurious or aggressive behavior

A photo of a female physician talking to her young female patient via a laptop.

<乌鸦传媒>More Medication Prescribed for Self-Managed Abortion After Roe Fell

While in-clinic abortions fell, many found other ways to access care

A photo of boxes of the drug mifepristone on a shelf

<乌鸦传媒>SCOTUS Again Takes on Issue of Abortion, This Time Over Mifepristone Access

Law professor says the case has the potential to upend how drug approvals function

FDA APPROVED macitentan/tadalafil (Opsynvi) over a computer rendering of the pulmonary arteries

<乌鸦传媒>Fixed-Dose Macitentan/Tadalafil Combo Gets FDA Approval for PAH

Opsynvi puts two drugs commonly prescribed for pulmonary arterial hypertension into one tablet

Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.

<乌鸦传媒>FDA Settles Ivermectin Case; When AI Makes a Medical Error; $97,000 Air Ambulance

Health news and commentary from around the Web gathered by 乌鸦传媒 staff

FDA EUA pemivibart (Pemgarda) over a computer rendering of antibodies attacking COVID viruses.

<乌鸦传媒>New Monoclonal Authorized to Prevent COVID in Immunocompromised People

No such option has been available since FDA revoked the authorization of Evusheld last year

FDA APPROVED oral givinostat (Duvyzat) over an anatomical model of the proximal muscles of the male body

<乌鸦传媒>Novel Drug Approved for All Duchenne Muscular Dystrophy Variants

Givinostat is the first nonsteroidal drug approved for DMD regardless of genetic mutation

FDA APPROVED bempedoic acid (Nexletol) over a computer rendering of a heart attack.

<乌鸦传媒>Expanded Label Officially Makes Bempedoic Acid a CVD Prevention Medication

New indications supported by CLEAR Outcomes trial

FDA APPROVED ponatinib (Iclusig) over a computer rendering of the destruction of lymphoblast cells

<乌鸦传媒>FDA Approves New Frontline Regimen for Aggressive ALL

Ponatinib lands indication in combination with chemo for Philadelphia chromosome-positive cases

A photo of proposed cigarette warning labels.

<乌鸦传媒>Graphic Images on Cigarettes of Smoking's Harm Are Constitutional, Court Rules

Partial victory for federal regulators seeking to toughen warning labels

A photo of Cathy McMorris Rodgers speaking during this hearing.

<乌鸦传媒>House Committee Wrestles With Lab Test Regulation

Some favor a proposed FDA rule, while others push for passage of the VALID Act

A screenshot of Xavier Becerra speaking during this hearing.

<乌鸦传媒>GOP Lawmakers Blast HHS, Biden for Plans to Loosen Marijuana Restrictions

Opposition to Medicaid work requirements also came on the table at a House hearing

FDA RECALL Impella left-sided blood pumps: Instructions For Use (IFU) over a computer rendering of the device

<乌鸦传媒>Wider Pool of Impella Heart Pumps Caught in Recall After 49 Deaths

Devices require label correction for left ventricle perforation risk

FDA APPROVED aprocitentan (Tryvio) over a photo of a man wearing a sphygmomanometer displaying a high blood pressure reading

<乌鸦传媒>Novel Oral Antihypertensive Gets FDA's Blessing

Aprocitentan becomes the first endothelin receptor antagonist for BP lowering

Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.

<乌鸦传媒>Kate Middleton's Medical Records; FDA Syringe Warning; NIH Ends COVID Guidelines

Health news and commentary from around the Web gathered by 乌鸦传媒 staff

FDA approved atidarsagene autotemcel (Lenmeldy) over a computer rendering of a motor neuron.

<乌鸦传媒>Pediatric Neuron Disease Gets Its First Gene Therapy

FDA approves arsa-cel for metachromatic leukodystrophy

FDA APPROVED fluticasone propionate (Xhance) over a computer rendering of a transparent head with the sinuses highlighted.

<乌鸦传媒>First Treatment Approved for Chronic Rhinosinusitis Without Nasal Polyps

Daily sprays of Xhance reduced acute exacerbations by 56% to 66% in trials

FDA ODAC ciltacabtagene autoleucel (cilta-cel, Carvykti) and idecabtagene vicleucel (ide-cel, Abecma) over multiple myeloma.

<乌鸦传媒>FDA Panel Gives Thumbs Up to Earlier Use of CAR T-Cell Therapy in Multiple Myeloma

Cilta-cel, ide-cel win support despite concerns about early mortality risk

FDA APPROVED lisocabtagene maraleucel (Breyanzi) over a computer rendering of CLL cells in the blood stream.

<乌鸦传媒>FDA Approves First CAR-T for Chronic Lymphocytic Leukemia

Lisocabtagene maraleucel (Breyanzi) nabs new indication for relapsed or refractory CLL/SLL

A scanning electron microscope image of fecal microbiota

<乌鸦传媒>FDA Tries to Close the Lid on Poop Transplant Company

Fecal microbiota transplant business needs a BLA or IND to operate, agency says

FDA APPROVED tislelizumab (Tevimbra) over a computer rendering of esophageal cancer.

<乌鸦传媒>New PD-1 Inhibitor Approved for Esophageal Cancer

Tislelizumab improved median OS from 6.3 months with chemotherapy to 8.6 months

FDA APPROVED resmetirom (Rezdiffra) over a computer rendering of a transparent body with the liver highlighted.

<乌鸦传媒>FDA Approves First-Ever Drug for Serious Liver Condition

Resmetirom indicated for NASH patients with liver scarring

FDA ODAC imetelstat (Rytelo) over a close up photo of a person receiving a blood transfusion.

<乌鸦传媒>FDA Panel Endorses Imetelstat for MDS-Related Anemia

By 12-2 vote, members find improvement in transfusion independence outweighs risk

FDA ODAC ciltacabtagene autoleucel (cilta-cel, Carvykti) and idecabtagene vicleucel (ide-cel, Abecma) over multiple myeloma.

<乌鸦传媒>Early Death Risk Muddies Risk-Benefit Assessment of CAR-T Therapies for Myeloma

FDA advisory panel to weigh the evidence for cilta-cel, ide-cel in day-long meeting

Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.

<乌鸦传媒>Don't Drive on These Meds; Darryl Strawberry's Heart Attack; CDC Airport Screening

Health news and commentary from around the Web gathered by 乌鸦传媒 staff

FDA ODAC imetelstat (Rytelo) over a close up photo of a person receiving a blood transfusion.

<乌鸦传媒>FDA Staff Cast Doubt on Novel Drug for MDS-Related Anemia

Agency asking its advisors if benefits outweigh risks for patients who fail on standard treatment

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