U.S. FDA Approves Takeda ’s Takhzyro (lanadelumab-flyo) to Prevent Hereditary Angioedema (HAE) Attacks in Children 2 Years of Age and Older
Takhzyro is the First and Only Prophylaxis Treatment Approved in the U.S. for Children 2 to<6 Years of Age With HAE1-4
Approval Supported by Extrapolation of Efficacy Data From the Phase 3 HELP Study With Additional Data From the Phase 3... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 3, 2023 Category: Drugs & Pharmacology Source Type: news
Tezspire Approved for Self-Administration in the U.S. With a New Pre-filled Pen
Now Offers Patients the Choice of Administration at Home or in a Doctor ' s Office
THOUSAND OAKS, Calif., Feb. 2, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced the U.S. Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 2, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Jesduvroq (daprodustat) for Anemia Caused by Chronic Kidney Disease for Adults on Dialysis
February 01, 2023 -- Today, the U.S. Food and Drug Administration approved Jesduvroq tablets (daprodustat) as the first oral treatment for anemia (decreased number of red blood cells) caused by chronic kidney disease for adults who have been... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 1, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Orserdu (elacestrant) for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer
ESR1 mutations are present in up to 40% of ER+, HER2- advanced or metastatic breast cancers.
ESR1 mutations are a known driver of resistance to standard endocrine therapy, and so far, have been difficult to treat.
Orserdu is the first endocrine... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 30, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Keytruda (pembrolizumab) as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Patients With Stage IB (T2a ≥4 Centimeters), II, or IIIA Non-Small Cell Lung Cancer (NSCLC)
Approval based on KEYNOTE-091 trial, which demonstrated a clinically meaningful improvement in disease-free survival with KEYTRUDA in these patients following surgical resection and platinum-based chemotherapy versus placebo
Approval marks fifth... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 27, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Jaypirca (pirtobrutinib) for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma
Jaypirca is the first BTK inhibitor of any kind specifically approved for patients with mantle cell lymphoma previously treated with a covalent BTK inhibitor
In the BRUIN Phase 1/2 trial, covalent BTK inhibitor pre-treated patients with relapsed... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 27, 2023 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Approves ALK's Odactra (House Dust Mite Allergen Extract) Tablet for Sublingual Use as Immunotherapy for Adolescents
Odactra is now indicated to treat house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, in persons 12 through 17 years of age, in addition to adults 18 through 65 years of age
Nearly 50% of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 25, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Brenzavvy (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes
MARLBOROUGH, Mass.--(BUSINESS WIRE) January 23, 2023 --TheracosBio today announced that the U.S. Food and Drug Administration (FDA) has approved Brenzavvy (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor. Brenzavvy is... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 23, 2023 Category: Drugs & Pharmacology Source Type: news
Brukinsa (zanubrutinib) Approved in the U.S. for Chronic Lymphocytic Leukemia
BASEL, Switzerland& BEIJING& CAMBRIDGE, Mass. -- January 19, 2023 --(BUSINESS WIRE)-- BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 19, 2023 Category: Drugs & Pharmacology Source Type: news
Seagen Announces FDA Accelerated Approval of Tukysa (tucatinib) in Combination with Trastuzumab for People with Previously Treated RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer
BOTHELL, Wash.--(BUSINESS WIRE) January 19, 2023 -- Seagen Inc. (Nasdaq: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tukysa (tucatinib) in combination with trastuzumab for adult patients... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 19, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Adacel for Immunization During Pregnancy to Help Protect Young Infants Against Pertussis
Expanded indication will help protect infants in the first months of life when their immune systems are still developing
Bridgewater, NJ, January 17th, 2023 -- The U.S. Food and Drug Administration (FDA) has approved Adacel (Tetanus... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 17, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Rykindo (risperidone) Extended-Release Injectable Suspension for the Treatment of Schizophrenia and Bipolar 1 Disorder
PRINCETON, N.J., Jan. 15, 2023 /PRNewswire/ -- Luye Pharma Group (Luye Pharma), an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications, today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 15, 2023 Category: Drugs & Pharmacology Source Type: news
Novo Nordisk Announces FDA Approval of Label Update for Rybelsus (semaglutide) Allowing Use as a First-Line Option for Adults with Type 2 Diabetes
People living with type 2 diabetes can now take Rybelsus®, the first and only oral glucagon-like peptide-1 (GLP-1) analog, along with diet and exercise, as initial therapy to help lower their A1C1,2
Since its approval, Rybelsus® has been... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 12, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Airsupra (albuterol/budesonide) Metered-Dose Inhaler to Reduce the Risk of Asthma Exacerbations
January 11, 2023 -- Airsupra (albuterol/budesonide), formerly known as PT027, has been approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 11, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Leqembi (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer's Disease
Accelerated Approval is based on Phase 2 data showing a reduction in amyloid-beta plaques in early AD patients treated with Leqembi™
Treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 6, 2023 Category: Drugs & Pharmacology Source Type: news
