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 stage of disease, the
Month: January 2023
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 and older. The approval
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 prescribed to hundreds of thousands of patients to help improve glycemic control along with diet and exercise3
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 Administration (FDA) has approved Rykindo
Bridgewater, NJ, January 17th, 2023 — The U.S. Food and Drug Administration (FDA) has approved Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed) during the third trimester of pregnancy to help protect against pertussis in infants younger than two months of age. Adacel is an FDA-approved Tdap vaccine indicated for active booster
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 with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
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 approved its Bruton’s tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL)
FDA Approves Brenzavvy (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes The FDA approval is based on results from a clinical program that evaluated the safety and efficacy of Brenzavvy in 23 clinical trials enrolling more than 5,000 adults with type 2 diabetes mellitus. Phase 3 studies showed Brenzavvy significantly reduced hemoglobin A1c
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 or refractory MCL achieved
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
HAYWARD, Calif., Jan. 23, 2023. Benitec Biopharma Inc. (“Benitec” or “the Company”), a development-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary DNA-directed RNA interference (“ddRNAi”) platform, today announced the enrollment of the first oculopharyngeal muscular dystrophy (OPMD) patient into the OPMD natural history phase of the BB-301 clinical development program.
TORONTO, Jan. 24, 2023. Diamond Therapeutics Inc. (“Diamond”), a drug development company focused on low-dose psychedelic-derived therapies for use in the treatment of mental health, is pleased to announce it has received Health Canada approval to begin a Phase 2 clinical trial evaluating the safety, tolerability and efficacy of repeat low-doses of psilocybin for the
BOSTON and ATLANTA, Jan. 25, 2023. Inhibikase Therapeutics, Inc. (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease, Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced the publication of studies describing the potential of IkT-148009 as a disease-modifying therapy for Parkinson’s
26 January 2023 — The US Food and Drug Administration (FDA) has stated that AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) is not currently authorised for Emergency Use for pre-exposure prophylaxis (prevention) of COVID-19 in the US until further notice, due to the sustained high frequency of circulating SARS-CoV-2 variants that Evusheld does not retain in
STOCKHOLM, Jan. 26, 2023. Pivotal study data published in The New England Journal of Medicine (NEJM) continues to highlight the efficacy, safety, and pharmacokinetic profile of efanesoctocog alfa (formerly BIVV001), a potential new medicine for haemophilia A. These data demonstrate the clinical benefits of normal to near-normal factor activity levels (>40%) for the majority of
RARITAN, N.J., Jan. 27, 2023. The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Phase 3 CARTITUDE-4 study evaluating CARVYKTI (ciltacabtagene autoleucel; cilta-cel) versus pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) for the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma met its primary endpoint of significant
Designation based on positive topline data from the ConquerRSV Phase 3 pivotal efficacy trial, which demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults CAMBRIDGE, MA / ACCESSWIRE / January 30, 2023 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines,
TOKYO & BASKING RIDGE, N.J.–(BUSINESS WIRE) January 30, 2023 –Daiichi Sankyo (TSE: 4568) today announced that the first patient has been dosed in the global, randomized TROPION-Lung07 phase 3 trial evaluating datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy, in patients with previously untreated advanced or metastatic non-squamous non-small cell lung
January 30, 2023 — A newly published paper in The Lancet shows that an experimental vaccine against Marburg virus (MARV) was safe and induced an immune response in a small, first-in-human clinical trial. The vaccine, developed by researchers at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health,
SAN DIEGO and TORONTO, Jan. 30, 2023. Aptose Biosciences Inc. (“Aptose”) today announced the 120 mg monotherapy dosing of patients in the APTIVATE Phase 1/2 clinical trial of tuspetinib (formerly HM43239), an oral, mutation agnostic tyrosine kinase inhibitor (TKI) being developed for the treatment of patients with relapsed or refractory acute myeloid leukemia (R/R AML).
Young adults who survive cancer are more likely than cancer-free siblings to be lonely and to develop emotional distress, risky behaviors, and new chronic conditions as a result, findings from a large retrospective study suggest. Young cancer survivors were two times more likely to report loneliness at study baseline and follow-up. Loneliness at these times
In this article PFE Follow your favorite stocksCREATE FREE ACCOUNT Empty vials of Pfizer-BioNTech coronavirus disease (COVID-19) children’s vaccines are pictured at Skippack Pharmacy in Schwenksville, Pennsylvania, U.S., May 19, 2022. Hannah Beier | Reuters The ongoing Covid-19 pandemic propelled pharmaceutical company Pfizer’s earnings to a record $100 billion last year, almost $57 billion of
Vials and a medical syringe seen displayed in front of the Food and Drug Administration (FDA) of the United States logo. FDA finds the COVID-19 vaccine. Pavlo Gonchar | LightRocket | Getty Images The Food and Drug Administration on Tuesday said its emergency authorizations of Covid vaccines, tests and treatments will not be impacted by
The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the causal agent of the ongoing coronavirus disease 2019 (COVID-19) pandemic, causes respiratory infection in people of all ages. Compared to adults, children are less frequently and severely affected by SARS-CoV-2. Although the exact reason for this is unclear, reduced expression of the angiotensin-converting enzyme 2 (ACE2) receptor
Metastases occur when cancer cells leave a primary tumor and spread throughout the body. For this, they have to break connections with neighboring cells and migrate to other tissues. Both processes are promoted by signaling molecules released by the cancer cells, which thereby increase the malignancy of tumors. A research team led by Prof. Dr.
A closer connection between those across the spectrum of life could hold some magnificent opportunities for all involved. Let’s explore the power of intergenerational living… How many people do you regularly interact with who are of a different age to you, another generation? Now take away your close friends and family, does that change things?
Data from the SWOG 1815 trial presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium showed that adding nab-paclitaxel (Abraxane) to gemcitabine (Gemzar) and cisplatin did not improve progression-free or overall survival for patients with advanced and metastatic biliary tract cancers, but did increase toxicity. In this exclusive MedPage Today video, Kristen
An ingenious innovation of a smart glove that costs less than $1 has been created with the aim to aid clinicians during birth. The study, published in the open-access journal Frontiers in Global Women’s Health, engineered the device to help healthcare staff in finding the fetal position and the force applied to the fetal head during
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