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

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.

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

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.

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.

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.

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

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

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.

Kate Middleton's Medical Records; FDA Syringe Warning; NIH Ends COVID Guidelines

Health news and commentary from around the Web gathered by 榴莲视频 staff

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

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.

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.

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.

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

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.

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.

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.

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.

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.

Don't Drive on These Meds; Darryl Strawberry's Heart Attack; CDC Airport Screening

Health news and commentary from around the Web gathered by 榴莲视频 staff

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

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

A photo of a female virologist marking samples with a marker in a laboratory.

Banning Gain-of-Function Research Would Do Far More Harm Than Good

A House-passed bill could stifle the potential for revolutionary medical advancements

FDA APPROVED nivolumab (Opdivo) over a computer rendering of bladder cancer.

First-Line Nivolumab Plus Chemo Approved for Bladder Cancer

Combination reduced risk of death by 22%

FDA APPROVED Dexcom Stelo Glucose Biosensor System over a photo of the device.

FDA Clears First OTC Continuous Glucose Monitor

Dexcom's Stelo system available without a prescription by the summer

FDA APPROVED Interchangeable biosimilars to Prolia and Xgeva over a computer rendering of bone affected by osteoporosis.

FDA OKs First Interchangeable Biosimilars for Denosumab

New products will carry all the same indications as Prolia and Xgeva, though launch date unclear

A photo of a bowl of yogurt with berries and granola

FDA Says Eating Yogurt May Reduce Diabetes Risk

Products will be allowed to carry claims as long as they don't mislead consumers

A photo of a man holding a can of Zyn nicotine pouches.

Zyn Nicotine Pouches Are All Over TikTok, Sparking Debate

Experts wrestle with their potential benefits and risks

FDA APPROVED amivantamab (Rybrevant) over a computer rendering of lung cancer.

FDA OKs Amivantamab as First-Line Lung Cancer Treatment

Bispecific drug lands full approval for NSCLCs with EGFR exon 20 insertion mutations

A photo of a chicken sandwich laying on its grease-proof wrapper.

FDA Announces End to 'Forever Chemicals' in U.S. Food Packaging

PFAS chemicals have been tied to a number of health issues

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

Abdominal Fat and Dementia; Mask Ban Lawsuit Tossed; FDA Rejects Psych Drug

Health news and commentary from around the Web gathered by 榴莲视频 staff

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

Amy Schumer's Diagnosis; FDA Yanks Cancer Drug; Nursing Student Murdered

Health news and commentary from around the Web gathered by 榴莲视频 staff

A photo of a Canadian flag flying from the porch of an inn in Gulfport, Florida.

FDA Authorized Florida's Drug Importation Plan. Naysayers Are Balking.

It's not an efficient solution

FDA APPROVED cefepime-enmetazobactam (Exblifep) over a computer rendering of a urinary tract infection

FDA Approves Antibiotic Combination for Complicated UTIs

Cefepime-enmetazobactam beat piperacillin-tazobactam in phase III study

FDA APPROVED Selective cytopheretic device-pediatric (SCD-PED) over a computer rendering of diseased kidneys.

FDA OKs Device for Pediatric Kidney Injury Due to Sepsis

The device was granted a Humanitarian Device Exemption approval

A photo of a woman watching a female physician speaking on a laptop

Medication Abortion Via Telehealth Safe and Effective, Study Finds

No difference in results between patients who received care via video vs secure text messaging

FDA APPROVED lifileucel (Amtagvi) over a photo of malignant melanoma on a man鈥檚 torso

FDA OKs First Cellular Therapy for Melanoma

Lifileucel approved as treatment for advanced melanoma after anti-PD-1 and targeted therapy

FDA APPROVED omalizumab (Xolair) over a photo of a syringe and vial laying on and next to a pile of peanuts

First Drug OK'd for Reducing Allergic Reactions From Multiple Foods

68% of patients who received omalizumab tolerated a single dose of peanut after 16-20 weeks

FDA APPROVED tepotinib (Tepmetko) over a computer rendering of a transparent body with lung cancer highlighted.

Tepotinib Gains Full Approval for Metastatic NSCLC

Agency converts accelerated approval for subset with MET exon 14 mutations

A screenshot of Peter Marks, MD, PhD, speaking during this hearing.

Lawmakers Clash Over COVID Vaccine Safety at House Hearing

Purpose of CDC's VAERS reporting system debated

A photo of boxes and blister packs of Paxlovid

COVID's Latest Adaptation: It Has Lulled Us to Sleep

My doctor's refusal to prescribe "just-in-case" Paxlovid speaks volumes

FDA APPROVED iloprost (Aurlumyn) over a photo of a man with severe frostbite on his fingers and thumbs.

FDA Approves First Drug for Severe Frostbite

Vasodilator iloprost significantly cut the risk of amputations in trial

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