TARRYTOWN, N.Y., April 12, 2021 /PRNewswire/ — Second Phase 3 trial undertaken in collaboration with NIAID to announce results today, both using subcutaneous administration of REGEN-COV in asymptomatic individuals without prior COVID-19 infection Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive data from a Phase 3 trial (2069B) of recently infected asymptomatic COVID-19 patients, evaluating REGEN-COV™ (casirivimab with
April 13, 2021 — A clinical trial testing the safety and efficacy of an investigational monoclonal antibody for treating people who are hospitalized with respiratory disease and low blood oxygen due to infection with SARS-CoV-2, the virus that causes COVID-19, has begun. The Phase 2 trial, called the COVID-19 anti-CD14 Treatment Trial (CaTT), is sponsored
News Clinical Trials Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine April 13, 2021 — As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and
This post was first published in 2019, but has been reviewed and updated in March 2021. It’s not new news that processed and red meat are linked to bowel cancer. But in 2019, Cancer Research UK scientists took a closer look at how much meat might be enough to increase bowel cancer risk. The study,
Cancer in children and young people is fundamentally different to cancer in adults – they require a different strategic approach and unique research. Because of this, we’re dedicated to funding research specific to cancers that affect children and young people. Joining forces with Children with Cancer UK, we’re proud to be co-funding the Cancer Research
Ductal carcinoma in situ (or DCIS) is a condition where some of the cells lining the ducts of the breast tissue have started to turn into cancer cells. It’s an example of something known as a pre-invasive cancer – the abnormal cells are all contained inside the lining of the ducts, but have the potential
At a time when cancer services in Wales have been severely disrupted due to the pandemic, the Welsh Government’s decision to publish just a short statement rather than a full cancer strategy on how it intends to provide and improve patient care over the next 5 years is unacceptable. Simply put, it’s failing cancer patients
Our Science Surgery series answers your cancer questions. Cancer can develop in nearly every organ in the body, including vital organs like the brain and lungs. As organs go, the heart is pretty vital – it’s basically one big muscle whose purpose is to pump blood around our bodies. Despite its importance, you very rarely
Medical research very rarely has a single end point. There is often no final answer, or silver bullet, the science just continues to evolve, and with it, there will always be more to do, understand and investigate.But sometimes it reaches a tipping point, where the knowledge that’s been built up actually alters medical practice.10 years
It has long been understood that the placenta is a very different organ to the rest of the body. But no-one knew quite how different. Last month, a fascinating piece of research shed light on the unique genetic structure of the placenta, revealing a level of detail that’s never before been seen. Researchers based at
Ever since the coronavirus pandemic brought the world to a standstill back in March 2020, there’s been talk of a vaccine. COVID-19 vaccines have been badged as our biggest opportunity to control the virus and return to normal. And for the last year, researchers and scientists across the world have been racing to make that
“How can I reduce my risk of cancer?” Over 40,000 people in the UK Google that or something similar each year. But despite thousands of us turning to the web for answers, it’s something many don’t feel comfortable talking about.But we want to change that. Around 1 in 2 people in the UK will be
The PillCam is used in colon capsule endoscopies to help diagnose bowel cancer. Credit: Medtronic A disposable camera that’s small enough to swallow and powerful enough to help rule out bowel cancer. And it could be coming to a clinic near you. Last month, NHS England announced a pilot programme that will offer some people
belzutifan Treatment for Renal Cell Carcinoma Merck Receives Priority Review From FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482) KENILWORTH, N.J.–(BUSINESS WIRE) March 16, 2021 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority
mavacamten Treatment for Hypertrophic Cardiomyopathy U.S. Food and Drug Administration (FDA) Accepts Bristol Myers Squibb’s Application for Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) PRINCETON, N.J.–(BUSINESS WIRE)– March 19, 2021 — Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for mavacamten,
tanezumab Treatment for Osteoarthritis Joint FDA Advisory Committee Votes on Application for Tanezumab for the Treatment of Osteoarthritis Pain NEW YORK AND INDIANAPOLIS, March 25, 2021—Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced the outcome of the U.S. Food and Drug Administration (FDA) Joint Arthritis Advisory Committee and Drug Safety and Risk
udenafil Treatment for Single Ventricle Heart Disease Mezzion Announces Re-Submission of New Drug Application for its Orphan Drug Udenafil to Treat Patients who have undergone the Fontan Operation for Single Ventricle Heart Disease SEOUL, South Korea, March 28, 2021 /PRNewswire/ – Mezzion Pharma Co. Ltd. (140410.KQ), announced today that it has re-submitted a New Drug Application (NDA) to
ublituximab Treatment for Chronic Lymphocytic Leukemia TG Therapeutics Completes Rolling Submission of Biologics License Application to the U.S. Food and Drug Administration for Ublituximab in Combination with Ukoniq (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia NEW YORK, March 29, 2021 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the completion
maralixibat Treatment for Cholestatic Pruritus in Patients with Alagille Syndrome Mirum Pharmaceuticals Announces FDA Acceptance of New Drug Application and Priority Review for Maralixibat in Alagille Syndrome FOSTER CITY, Calif.–(BUSINESS WIRE)–Mar. 29, 2021– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announced today that its New Drug Application (NDA) for maralixibat, an oral apical sodium dependent bile acid transporter (ASBT)
atogepant Treatment for Migraine Prophylaxis U.S. FDA Accepts AbbVie’s New Drug Application for Atogepant for the Preventive Treatment of Migraine NORTH CHICAGO, Ill., March 30, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for atogepant, an investigational orally administered calcitonin gene-related peptide
vadadustat Treatment for Anemia Associated with Chronic Renal Failure Akebia Submits New Drug Application (NDA) to the FDA for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis CAMBRIDGE, Mass., March 30, 2021 /PRNewswire/ – Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of
abrocitinib Treatment for Atopic Dermatitis Pfizer Announces Extension of Review of New Drug Application of Abrocitinib for the Treatment of Moderate to Severe Atopic Dermatitis NEW YORK–(BUSINESS WIRE) April 07, 2021 — Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has extended the priority review period for the New
tisotumab vedotin Treatment for Cervical Cancer Genmab and Seagen Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer COPENHAGEN, Denmark and BOTHELL, Wash.; April 09, 2021 – Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has
FDA Approves Zegalogue (dasiglucagon) Injection for the Treatment of Severe Hypoglycemia in People with Diabetes Copenhagen, DK and Boston, MA, U.S. March 22, 2021 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078,) a biotechnology company aspiring to deliver innovation with novel peptide therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has approved Zegalogue® (dasiglucagon)
KENILWORTH, N.J.–(BUSINESS WIRE) March 23, 2021 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to
FDA Approves Abecma (idecabtagene vicleucel) as the First Anti-BCMA CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma PRINCETON, N.J., & CAMBRIDGE, Mass.–(BUSINESS WIRE) March 26, 2021 — Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has approved Abecma (idecabtagene vicleucel;
TOKYO, March 26, 2021 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) approved Myrbetriq (mirabegron extended-release tablets) for the treatment of NDO in pediatric patients aged three years and older who weigh 35 kg or more, and Myrbetriq Granules
DUBLIN, March 30, 2021 /PRNewswire/ – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved a revised label for Vyxeos® (daunorubicin and cytarabine) to include a new indication to treat newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients aged one year and older. The approval of Vyxeos for this indication