-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
- Cosmetic Ingredient
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
Every year, the FDA's Center for Drug Evaluation and Research (CDER) approves a series of new drugs and biological products, including innovative drugs that have never been used in clinical practice
.
A total of 50 new molecular entities and new therapeutic biological products will be approved by CDER in 2021 (excluding vaccines, sensitization products, blood and blood products, plasma derivatives, cell and gene therapy products)
1.
Brexafemme
Brexafemme
On June 2, 2021, SCYNEXIS announced that the FDA has approved the use of BREXAFEMME (ibrexafungerp tablets), the first and only oral non-azole drug for vaginal yeast infections and the first to be approved in more than 20 years novel triterpenoid antifungal drugs
.
2.
Lybalvi
Lybalvi
On June 1, 2021, Alkermes plc announced that the FDA has approved LYBALVI (olanzapine and samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder
.
LYBALVI is an oral once-daily atypical antipsychotic consisting of olanzapine (olanzapine, a recognized antipsychotic) and samidorphan (a new chemical)
3.
Truseltiq
Truseltiq
On May 28, 2021, BridgeBio Pharma Group announced that the FDA has granted accelerated approval to TRUSELTIQ™ (infigratinib) for the treatment of previously treated patients with locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements
.
TRUSELTIQ is an oral ATP-competitive fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor (TKI)
4.
Lumakras
Lumakras
On May 28, 2021, Amgen announced that the FDA has approved LUMAKRAS™ (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, the first and The only targeted therapy currently available
.
5.
Pylarify
Pylarify
On May 26, 2021, Lantheus Holdings announced that the FDA has approved PYLARIFY, an F18-labeled prostate-specific membrane antigen-targeted positron emission tomography imaging agent, for the identification of suspected prostate cancer metastasis or recurrence
.
PYLARIFY is the first and only commercially approved prostate-specific membrane antigen PET imaging agent for prostate cancer
6.
Rybrevant
Rybrevant
Janssen Pharmaceuticals, a Johnson Group company, announced on May 21, 2021 that the FDA has granted accelerated approval to RYBREVANT™ (amivantamab-vmjw) for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) exon 20 implantation mutations Adult patients with small cell lung cancer
.
RYBREVANT™ is the first fully human bispecific antibody approved for the treatment of patients with non-small cell lung cancer targeting EGFR exon 20 insertion mutations, one of the most common EGFR activating mutations.
7.
Empaveli
Empaveli
On May 14, 2021, Apellis announced that the FDA has approved Empaveli (pegacacplan) injection for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults
.
Empaveli is the first PNH therapy that binds complement protein C3
8.
Zynlonta
Zynlonta
On April 23, 2021, ADC Therapeutics announced that the FDA has granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta; ADC Therapeutics SA) for the treatment of relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, low-grade Lymphoma and high-grade B-cell lymphoma, and the patient has received ≥2 series of systemic therapy
.
Zynlonta is the first and only intravenous CD19-targeting antibody and alkylating agent conjugate to be granted orphan drug designation by the FDA
9.
Jemperli
Jemperli
On April 22, 2021, GlaxoSmithKline announced that the FDA has approved Jemperli (dostarlimab-gxly) for the treatment of adult patients with unmatched repair-deficient recurrent or advanced endometrial cancer
.
Jemperli is a programmed death-1 (PD-1) blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2
10.
Nextstellis
Nextstellis
On April 15, 2021, Mayne Pharma and Mithra Pharmaceuticals announced that the FDA has approved a New Drug Application for NEXTSTELLIS, a 3 mg drospirenone (DRSP) and 14.
2 mg estetrol (E4) tablet, a novel combination oral contraceptive
.
NEXTSTELLIS is the first and only estrogen-containing birth control pill, and its ingredient, estetrol, is extracted from a plant and is the first new estrogen introduced in the United States in over 50 years
.
11.
Qelbree
Qelbree
On April 2, 2021, Supernus Pharmaceuticals announced that the FDA has approved Qelbree as a novel non-stimulant drug for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years
.
Qelbree (viloxazine extended-release capsules), a selective norepinephrine reuptake inhibitor, is the first new non-stimulant drug for the treatment of ADHD in children and adolescents in more than 10 years
.
12.
Zegalogue
Zegalogue
On March 22, 2021, Zealand Pharma announced that the FDA has approved Zegalogue (dasigagon) injection for the treatment of severe hypoglycemia in children and adults 6 years of age and older with diabetes
.
Zegalogue is the first and only glucagon analog for the treatment of severe hypoglycemia
.
13.
Ponvory
Ponvory
On March 19, 2021, Janssen Pharmaceuticals announced that the FDA has approved PONVORY (ponesimod) for the treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progression sexually transmitted diseases
.
PONVORY, an oral once-daily selective sphingosine-1-phosphate receptor 1 modulator, is the first and only FDA-approved oral disease modifying therapy
.
14.
Fotivda
Fotivda
On March 10, 2021, AVEO Oncology announced that the FDA has approved FOTIVDA (tivozanib) for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma
.
FOTIVDA is an oral next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)
.
FOTIVDA is the first approved treatment for the disease
.
15.
Azstarys
Azstarys
On March 2, 2021, Corium announced that the FDA has approved AZSTARYS™ and dexmethylphenidate for the treatment of symptoms of attention deficit hyperactivity disorder in patients 6 years of age and older
.
This is the first and only drug taken orally once daily to treat ADHD
.
16.
Pepaxto
Pepaxto
On February 26, 2021, Oncopeptides A announced that the FDA has approved PEPAXTO (melphalan flufenamide) in combination with dexamethasone (dexamethasone) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four previous treatments.
therapy and are resistant to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-targeting monoclonal antibody
.
PEPAXTO is the first FDA-approved anticancer peptide-drug conjugate
.
17.
Nulibry
Nulibry
On February 26, 2021, BridgeBio Pharma and Origin Biosciences announced that the FDA has approved NULIBRY (fosdenopterin) as the treatment of choice to reduce the risk of death in patients with molybdenum cofactor A deficiency
.
This is the first and only treatment for the disease
.
18.
Amondys 45
Amondys 45
On February 25, 2021, Sarepta Therapeutics announced that the FDA has approved Amondys 45 (casimersen) injection for the treatment of patients with Duchenne muscular dystrophy (DMD) who have a DMD gene mutation that causes exon 45 skipping
.
This is the first FDA-approved targeted therapy for patients with this mutation
.
19.
Cosela
Cosela
On February 12, 2021, G1 Therapeutics announced that the FDA has approved COSELA (trilaciclib) to reduce chemotherapy-induced bone marrow reduction in adult patients prior to the use of platinum/etoposide-containing regimens or topotecan-containing regimens for extensive-stage small cell lung cancer.
Inhibition of the incidence of treatment
.
This is the first and only treatment used to protect the bone marrow prior to chemotherapy treatment
.
20.
Evkeeza
Evkeeza
On February 11, 2021, Regeneron Pharmaceuticals announced that the FDA approved Evkeeza™ (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol-lowering therapies for the treatment of adults 12 years of age and older with homozygous familial hypercholesterolemia and pediatric patients
.
Evkeeza is the first FDA-approved therapeutic that binds and blocks the function of angiopoietin-like 3 (ANGPTL3), a protein that plays a key role in lipid metabolism
.
21.
Ukoniq
Ukoniq
On February 5, 2021, TG Therapeutics announced that the FDA has approved UKONIQ (umbralisib) for adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and who have received at least three prior systemic therapies treatment of adult patients with relapsed or refractory follicular lymphoma
.
UKONIQ is the first and only once-daily oral inhibitor of phosphoinositide 3-kinase (PI3K)-delta and casein kinase 1 (CK1)-ԑ
.
22.
Tepmetko
Tepmetko
On February 3, 2021, Merck announced that the FDA has approved TEPMETKO (tepotinib) for the treatment of adult patients with metastatic non-small cell lung cancer with mesenchymal-epithelial transition (MET) exon 14 mutations
.
TEPMETKO is the first and only FDA-approved MET inhibitor
.
23.
Lupkynis
Lupkynis
On January 22, 2021, Aurinia Pharmaceuticals announced that the FDA has approved LUPKYNISTM (voclosporin) in combination with a background immunosuppressive therapy for the treatment of adult patients with active lupus nephritis (LN)
.
LUPKYNIS is the first FDA-approved oral drug for the treatment of LN
.
24.
Cabenuva
Cabenuva
On January 21, 2021, ViiV Healthcare announced that the FDA has approved Cabenuva for the treatment of HIV
.
Cabenuva allows HIV-infected patients to maintain viral suppression with a 12-day annual dose without treatment failure or resistance to cabtegravir or rilpivirine, and is the first and only complete long-acting regimen for the treatment of HIV infection in adults
.
25.
Verquvo
Verquvo
On January 20, 2021, Merck Corporation announced that the FDA has approved VERQUVO for the treatment of patients with symptomatic chronic heart failure and an ejection fraction of less than 45% after hospitalization for heart failure or the need for outpatient intravenous diuretics.
Risk of cardiovascular death and hospitalization for heart failure
.
VERQUVO, a soluble guanylate cyclase stimulator, is the first treatment for chronic heart failure specifically approved for patients hospitalized for heart failure or requiring outpatient intravenous diuretics
.
References:
References: [1] Novel Drug Approvals for 2021.
https:// -2021
https:// -2021
