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Drug Approval News

Date Posted
Article Title
FDA Approves First Ebola Virus Treatment

Inmazeb approved for adults and children including newborns of mothers who test positive for Ebola virus

Drug Combo Approved for First-Line Treatment of Mesothelioma

Opdivo-Yervoy combination approved to treat adults with unresectable malignant pleural mesothelioma

FDA Approves Nucala for Hypereosinophilic Syndrome

Indicated for patients 12 years and older with HES for six months or longer and no non-blood-related cause

Drug Granted Accelerated Approval for Rare Duchenne Muscular Dystrophy Mutation

Viltepso approved for DMD with mutation of DMD gene amenable to exon 53 skipping

New IV Opioid Approved for Use in Controlled Settings

Olinvyk indicated for short-term IV use in adults with moderate-to-severe acute pain

FDA Approves First Oral Drug for Spinal Muscular Atrophy

Evrysdi approved for at-home administration for patients ages 2 months and older with SMA

Tecartus Approved for Treatment of Mantle Cell Lymphoma

Drug is first cell-based gene therapy approved for the treatment of MCL

FDA Approves Oral Treatment for Myelodysplastic Syndrome

Inqovi is an oral outpatient treatment option for patients needing IV therapy

Rukobia Approved for Patients With Multidrug-Resistant HIV

Drug marks the first approval in a class of antiretroviral treatments for heavily treatment-experienced people with HIV

FDA OKs Second Treatment for Neuromyelitis Optica Spectrum Disorder

Uplizna approved for neuromyelitis optica spectrum disorder patients who are anti-AQP4 antibody positive

Tivicay Approved for Treatment of HIV-1 in Pediatric Patients

Tablets and tablets for suspension indicated for children age 4 weeks and older, weighing at least 3 kg

VESIcare LS Approved for Neurogenic Detrusor Overactivity

Oral suspension treatment is the first approved for NDO patients as young as 2 years

FDA Approves IV Artesunate for Severe Malaria

Drug is first to be approved since discontinuation of quinine in 2019

Qinlock Approved as Fourth-Line Treatment for GIST

Approval based on study showing PFS of 6.3 months with Qinlock versus one month with placebo

FDA Approves Retevmo for Certain Lung, Thyroid Cancers

Approval indicated for NSCLC, medullary thyroid cancer, other thyroid cancers with RET gene alteration

FDA OKs Farxiga for Heart Failure With Reduced Ejection Fraction

The SGLT2 inhibitor is indicated for reducing the risk for CV death, hospitalization for heart failure

FDA Approves Trodelvy for Metastatic Triple-Negative Breast Cancer

Approval indicated for those who have received at least two previous therapies

Tukysa Approved for Unresectable, Metastatic HER2-Positive Breast Cancer

Drug indicated for patients who have previously received treatment with one or more anti-HER2-based regimen

Pemazyre Approved for Treatment of Advanced Cholangiocarcinoma

Drug indicated for locally advanced or metastatic cholangiocarcinoma and tumors with FGFR2 fusion or rearrangement

FDA Approves First Therapy for Low-Grade UTUC

Jelmyto provides alternative to patients with low-grade upper tract urothelial cancer

FDA Approves Koselugo for Pediatric Neurofibromatosis Type 1

Approval based on data showing 66 percent overall response rate

Epclusa Approved for Children With Any Hep C Genotype

Supplemental application of Epclusa approved to treat HCV in children without cirrhosis, with mild cirrhosis

Ofev Approved for Chronic Fibrosing ILDs With Progressive Phenotype

Approval based on data showing slowed decline in lung function compared with placebo

FDA Approves Treatment for Cushing Disease

Isturisa indicated for patients who are not candidates for pituitary gland surgery or are not cured after surgery

Sarclisa Approved for Treatment of Multiple Myeloma

Sarclisa combined with pomalidomide and dexamethasone indicated for patients with at least two prior therapies

FDA Approves Voltaren Arthritis Pain, Pataday for OTC Use

Voltaren Arthritis Pain, Pataday Twice Daily Relief, Pataday Once Daily Relief now marketed as nonprescription drugs

First Drug Approved for Treatment of Peanut Allergy in Children

Combined with peanut avoidance, treatment with Palforzia shown to alleviate allergic reactions

Tazverik Approved to Treat Metastatic, Locally Advanced Epithelioid Sarcoma

Approval marks the first for a drug to treat this rare soft tissue sarcoma

Ayvakit Approved to Treat GIST With PDGFRA Exon 18 Mutation

Drug is first specifically approved for GISTs harboring PDGFRA exon 18 mutation

Enhertu Approved for Unresectable, Metastatic HER2+ Breast Cancer

Treatment indicated for patients who have received at least two previous anti-HER2-based regimens

FDA Approves Padcev for Treatment of Advanced Urothelial Cancer

Drug indicated for adults previously treated with PD-1, PD-L1 inhibitor and platinum-based therapy

FDA Approves Oxbryta for Treatment of Sickle Cell Disease

Drug is first approved treatment that directly inhibits sickle hemoglobin polymerization

FDA Approves XCOPRI for Treatment of Partial-Onset Seizures

Versus placebo, percent of seizures per 28 days reduced with 100-, 200-, 400-mg doses of XCOPRI

Givlaari Approved for Acute Hepatic Porphyria

Subcutaneous injection once monthly aims to help reduce the number of porphyria attacks

Calquence Approved to Treat CLL, SLL

Progression free-survival longer with Calquence versus other standard treatments

Brukinsa Approved for Relapsed, Refractory Mantle Cell Lymphoma

Two clinical trials showed tumor shrinkage in 84 percent of patients

Fetroja Approved to Treat Complicated Urinary Tract Infections

Label warns higher mortality found in critically ill patients with multidrug-resistant Gram-negative bacterial infections

Reblozyl Approved to Treat Anemia in Patients With Beta Thalassemia

Drug is first therapy approved to help reduce number of blood transfusions

FDA Approves Reyvow for Acute Migraine

In clinical trials, pain resolved at two hours in significantly more patients taking Reyvow versus placebo

Implant Approved for Patients With Phototoxic Reactions From Rare Disorder

Scenesse increases pain-free light exposure in patients with erythropoietic protoporphyria

FDA Approves Descovy for HIV-1 Preexposure Prophylaxis

Drug indicated to reduce risk for HIV-1 infection from sex excluding receptive vaginal sex

Rituxan Approved for Pediatric Patients With Rare Vasculitis Diseases

Approval of Rituxan expanded to children with granulomatosis with polyangiitis, microscopic polyangiitis

Mavyret Approved as 8-Week Treatment for Hep C, Compensated Cirrhosis

Drug approval expanded to any treatment-naive HCV patients, regardless of cirrhosis status or treatment type

FDA Approves First Treatment for ILD With Systemic Sclerosis, Scleroderma

Approval of Ofev for this indication based on data from SENSCIS study

Nourianz Approved to Treat 'Off' Episodes in Parkinson Disease

Drug showed efficacy as add-on treatment for 'off' episodes in PD patients taking levodopa/carbidopa