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Cabotegravir is a ViiV product marketed as Cabenuva, and rilpivirine is a Janssen product with a brand name Edurant. Today’s FDAapproval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” said Lynn Baxter, Head of North America, ViiV Healthcare.
FDAApproves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. This indication is approved under accelerated approval regulation based on overall response rate and duration of response. The FDA granted approval under the accelerated approval regulation. NEW YORK, Nov. Contraindications.
Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel, advancing the company’s commitment to personalised healthcare through tests that determine which patients are most likely to benefit from specific and targeted therapies. today announced U.S. Read more about Roche innovation in MMR biomarker testing.
10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication was approved under accelerated approval based on tumor response rate and duration of response.
The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
FDAApproves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. With this approval, Imcivree becomes the first-ever FDAapproved therapy for these rare genetic diseases of obesity. BOSTON, Nov. in the first quarter of 2021.
FDAApproves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.
Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDAapproval, the U.S. in 1-15 year olds and 98.7-100%
FDAApproves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Klisyri is the first FDAapproved branded proprietary product for Athenex and will be launched in partnership with Almirall in the U.S. The FDAapproval of Klisyri is a significant milestone for Athenex. “The
based subsidiary of Terumo and a global neurovascular company, announced today the FDAApproval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. .
ALISO VIEJO, Calif. ,
Dive into this week’s update for more details on the actions taken by the FDA in the ongoing response to the Covid-19 pandemic. FDAapproves first treatment for Covid-19. On October 22, the FDAapproved the antiviral drug Veklury for use in adult and pediatric patients for the treatment of Covid-19 requiring hospitalization.
FDAApproves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.
Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction FDAapproval marks a significant breakthrough for the approximately 3 million adults in the U.S. and Europe.
Altasciences’ ability to design and conduct specialized tests, combined with our partnership with CRC, allows us to seamlessly incorporate driving simulation elements into your clinical trials. Tags Clinical Trials Weight 12 View the Driving Simulation Fact Sheet for more information.
In a pivotal head-to-head Phase III SOPHIA clinical trial, it became the first HER2-targeted therapy to improve progression-free survival (PFS) versus Herceptin® (trastuzumab), when each was combined with chemotherapy. The FDAapproval of Klisyri is a significant milestone for Athenex. at the time of the announcement.
FDAapproval Pfizer (NYSE: PFE) announced that the U.S. With today’s FDAapproval of TALZENNA plus XTANDI, we are proud to be able to offer this potentially practice-changing treatment to patients and add to their options in managing this aggressive disease.” 0.61; p<0.0001). .
This morning, California-based GW said it will launch the first Phase III trial studying nabiximols, which is known as Sativex outside the United States, as a potential treatment for multiple sclerosis-associated spasticity. Sativex is approved for use in parts of Europe for this indication. It also forced the U.S.
Food and Drug Administration (FDA) has approved ORLADEYO (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and young patients 12 years and older. The approval was based on data from the Phase 3 APeX-2 trial, which showed that ORLADEYO could significantly reduce attacks at the 24-week mark.
Food and Drug Administration (FDA) to expand the approval of COMIRNATY® (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years. The sBLA includes updated longer-term follow-up data from the companies pivotal Phase 3 clinical trial of 2,228 participants 12 through 15 years of age.
However, the subsequent death of another patient thrust Denys into a contentious trial. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial. The results of the trial are expected at the end of 2024. Data from Rousseau G.F.
today announced that the company’s Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the European Medicines Agency (EMA). Additional data from the CAPELLA study will be presented at a future scientific conference.
Still, more than 90 percent of drug candidates fail in clinical trials, with even more that never make it to the clinical stage. Drug toxicity can be an issue even after FDAapproval; drug-induced cardiotoxicity (DICT) and drug-induced liver injury (DILI) each contribute to a significant percentage of post-market drug withdrawals.
Read the Paper Rare Roundup Cautious Optimism for Newly Approved Drug for Rare Form of Genetic ALS When is there enough evidence for a drug that we can call it a treatment for a disease? This question permeates every step of the drug development process, from testing in cells and animal models to clinical trials and regulatory approval.
NIH trial seeks answers. (
Third time’s the charm as Heron wins FDA nod for non-opioid anesthetic Zynrelef ( Endpoints ).
Amgen, AstraZeneca bolster their case for breakthrough asthma program as FDA considers taking up a review ( Endpoints ).
In Focus: International.
Purdue’s Ch.
Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and principal investigator of the FIDELIO-DKD trial. FDA has approved finerenone for marketing authorization in the U.S. Based on the positive data from FIDELIO-DKD, the U.S.
Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDAapproval, the U.S.
WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDAapproval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.
NYSE: PFE) announced updated results from the Phase 3 CROWN trial, which evaluated LORBRENA® (lorlatinib, available in Europe under the brand name LORVIQUA) versus XALKORI® (crizotinib) in people with previously untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). Pfizer Inc.
Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics.
As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e., futility analysis).
Progress is being powered by strong marketable prosecution in a positive request terrain, particularly in pesticides and dressings. “ Our commanding marketable portfolio, digital platform and unmatched invention are driving significant value for our farmer guests. is underway. added Condon. “ and Brazil alone.
The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. . The UDI disrupted market competition for many years. manufacturers to 3.0 Source link.
Teva and MedinCell Announce FDAApproval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. UZEDY will be available in the U.S.
Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Food and Drug Administration (FDA) approval. The FDA Since 1983.
Adds Rezurock™ (belumosudil) an FDA-approved, first-in-class treatment for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. The Sanofi and Kadmon Boards of Directors unanimously approved the transaction. “We
ONCR-177, its lead oncolytic herpes simplex virus (oHSV)-based immunotherapy, is in human trials as a monotherapy and in combination with Merck’s Keytruda (pembrolizumab) for a range of solid tumors. from the market close last Thursday. At least one other company is developing next-generation oncolytic virus-based immunotherapies.
Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy.
Protalix was the first company to gain FDAapproval of a protein produced through plant cell-based in suspension expression system.
CARMIEL, Israel and BOSTON , Dec.
While research to optimise BiTE molecules and refine their capabilities is ongoing, this is where most FDAapprovals are taking place as the field is developing so rapidly. Two BiTE therapies are already on the market for the treatment of multiple myeloma, and I expect to see many more BiTEs to be unveiled this year.
One large-scale clinical trial found that it only reduces the relative risk of death by about ten percent in hospitalized patients. Whereas hydroxychloroquine had already been approved for diseases with established markets, remdesivir lacked approval for any commercially-relevant indication prior to the pandemic.
The FDAapproves around 50 new drugs each year after clinical trials and data analyses demonstrate a drug’s safety and effectiveness. To expedite getting potentially beneficial new drugs to seriously ill patients, some of these new drugs are approved through the FDA’s accelerated approval pathway.
DEXTENZA is FDAapproved for the treatment of ocular inflammation and pain following ophthalmic surgery. The safety of DEXTENZA was assessed in three Phase 3 clinical trials and a Phase 2 clinical trial. About DEXTENZA. DEXTENZA resorbs and exits the nasolacrimal system without the need for removal.
Our business is growing, and we remain focused on the potential opportunity to launch vibegron in 2021, pending FDAapproval,” said Urovant Sciences President and chief executive officer, James Robinson. Vibegron also showed favorable longer-term efficacy, safety, and tolerability in a 40-week extension study. .
1] Palopegteriparatide was approved for medical use in the European Union in November 2023, [2] and in the United States in August 2024. [1] 5] History The effectiveness of palopegteriparatide was evaluated in a 26-week, randomized, double-blind, placebo-controlled trial that enrolled 82 adults with hypoparathyroidism. [5]
The FDAapproved the first gene therapy in 2017 for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL), and as of December 2023, there are over 30 approved cell and gene therapies on the market in the U.S.A. Asia, and Europe.
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