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
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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
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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
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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
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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
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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,
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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
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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
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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
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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)
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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
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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
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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
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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
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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)
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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
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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;
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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
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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
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