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Drug Approval News

Date Posted
Article Title
10/15/2020
FDA Approves First Ebola Virus Treatment

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

10/5/2020
Drug Combo Approved for First-Line Treatment of Mesothelioma

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

10/1/2020
9/29/2020
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

8/13/2020
Drug Granted Accelerated Approval for Rare Duchenne Muscular Dystrophy Mutation

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

8/10/2020
New IV Opioid Approved for Use in Controlled Settings

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

8/10/2020
FDA Approves First Oral Drug for Spinal Muscular Atrophy

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

7/27/2020
Tecartus Approved for Treatment of Mantle Cell Lymphoma

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

7/8/2020
FDA Approves Oral Treatment for Myelodysplastic Syndrome

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

7/7/2020
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

6/14/2020
FDA OKs Second Treatment for Neuromyelitis Optica Spectrum Disorder

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

6/12/2020
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

5/27/2020
VESIcare LS Approved for Neurogenic Detrusor Overactivity

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

5/27/2020
FDA Approves IV Artesunate for Severe Malaria

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

5/18/2020
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

5/11/2020
FDA Approves Retevmo for Certain Lung, Thyroid Cancers

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

5/6/2020
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

4/23/2020
FDA Approves Trodelvy for Metastatic Triple-Negative Breast Cancer

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

4/20/2020
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

4/20/2020
Pemazyre Approved for Treatment of Advanced Cholangiocarcinoma

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

4/17/2020
FDA Approves First Therapy for Low-Grade UTUC

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

4/14/2020
FDA Approves Koselugo for Pediatric Neurofibromatosis Type 1

Approval based on data showing 66 percent overall response rate

3/20/2020
Epclusa Approved for Children With Any Hep C Genotype

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

3/10/2020
Ofev Approved for Chronic Fibrosing ILDs With Progressive Phenotype

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

3/9/2020
FDA Approves Treatment for Cushing Disease

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

3/3/2020
Sarclisa Approved for Treatment of Multiple Myeloma

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

3/2/2020
2/19/2020
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

2/3/2020
First Drug Approved for Treatment of Peanut Allergy in Children

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

1/24/2020
Tazverik Approved to Treat Metastatic, Locally Advanced Epithelioid Sarcoma

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

1/14/2020
1/10/2020
Ayvakit Approved to Treat GIST With PDGFRA Exon 18 Mutation

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

12/23/2019
Enhertu Approved for Unresectable, Metastatic HER2+ Breast Cancer

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

12/20/2019
12/19/2019
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

12/6/2019
11/26/2019
FDA Approves Oxbryta for Treatment of Sickle Cell Disease

Drug is first approved treatment that directly inhibits sickle hemoglobin polymerization

11/25/2019
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

11/22/2019
Givlaari Approved for Acute Hepatic Porphyria

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

11/22/2019
Calquence Approved to Treat CLL, SLL

Progression free-survival longer with Calquence versus other standard treatments

11/18/2019
Brukinsa Approved for Relapsed, Refractory Mantle Cell Lymphoma

Two clinical trials showed tumor shrinkage in 84 percent of patients

11/15/2019
Fetroja Approved to Treat Complicated Urinary Tract Infections

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

11/13/2019
Reblozyl Approved to Treat Anemia in Patients With Beta Thalassemia

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

10/11/2019
FDA Approves Reyvow for Acute Migraine

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

10/9/2019
Implant Approved for Patients With Phototoxic Reactions From Rare Disorder

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

10/4/2019
FDA Approves Descovy for HIV-1 Preexposure Prophylaxis

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

10/1/2019
Rituxan Approved for Pediatric Patients With Rare Vasculitis Diseases

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

9/30/2019
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

9/9/2019
FDA Approves First Treatment for ILD With Systemic Sclerosis, Scleroderma

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

8/28/2019
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