Drugs

FDA Approves Nextstellis (drospirenone and estetrol) Oral Contraceptive for Birth Control 15 April 2021, Adelaide, Australia and Liege, Belgium: Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are very pleased to announce that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for the novel
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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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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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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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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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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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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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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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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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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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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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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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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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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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FDA Approves Roszet (rosuvastatin and ezetimibe) to Reduce LDL-C in Hyperlipidemia and Homozygous Familial Hypercholesterolemia Morristown, N.J. March 31, 2021 — Althera Pharmaceuticals, a company focused on heart health, today announced the FDA approval of Roszet (rosuvastatin and ezetimibe) tablets, as an adjunct to diet, for treatment of elevated low-density lipoprotein cholesterol (LDL-C) in adult
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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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PARIS, March 31, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. “In the Phase 3 IKEMA study, the addition
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FDA Approves Qelbree (viloxazine) for the Treatment of ADHD ROCKVILLE, Md., April 02, 2021 (GLOBE NEWSWIRE) – Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) approved Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity
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South San Francisco, CA — April 12, 2021 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair (omalizumab) prefilled syringe for self-injection across all approved U.S. indications. Xolair is the only
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FOSTER CITY, Calif.–(BUSINESS WIRE)–Apr. 7, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The
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March 17, 2021 Audience: Consumers March 17, 2021 — Raleigh, North Carolina, PNHC, LLC, d/b/a Heal the World, is voluntarily recalling all lots of Heal the World hand sanitizer packaged in 9.6 fl. oz containers to the consumer level. The products are being recalled because they resemble 9.6ounce water bottles. The recall does not affect
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March 24, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy March 24, 2021 — FDA Safety Communication Purpose: To inform the public and healthcare providers that FDA has required and approved safety labeling changes to the Prescribing Information for Shingrix (Zoster Vaccine Recombinant, Adjuvanted) to include a new warning about the risk for Guillain-Barré Syndrome (GBS)
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March 24, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy March 24, 2021 — Bridgewater, NJ, Alembic Pharmaceuticals, Inc is voluntarily recalling one lot of Telmisartan Tablets, USP, 20 mg, packaged in 30-count bottles, Lot No. 1905005661 to the consumer level. The product is being recalled due to a market complaint received which stated that one
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March 25, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy March 25, 2021 — Pennington, NJ, Zydus Pharmaceuticals (USA) Inc. is voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, to the Hospital/User level after receiving several complaints of crystallization in vials. Administration of crystalized Acyclovir Sodium Injection, 50
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March 25, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy March 25, 2021  — The U.S. Food and Drug Administration (FDA) is warning that the abuse and misuse of the overthe-counter (OTC) nasal decongestant propylhexedrine can lead to serious harm such as heart and mental health problems. Some of these complications, which include fast or abnormal
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March 31, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy March 31, 2021 Weston, Florida – Apotex Corp is voluntarily recalling three (3) lots of Guanfacine Extended-Release Tablets 2mg to the consumer level due to trace amounts of Quetiapine Fumarate in one lot RX1663. Out of an abundance of caution, lots RX1662 and RX1664 are also included
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March 31, 2021 Audience: Patient, Health Professional, Pharmacy, Neurology, Cardiology, Psychiatry ISSUE: An FDA review of study findings showed a potential increased risk of heart rhythm problems, called arrhythmias, in patients with heart disease who are taking the seizure and mental health medicine Lamictal (lamotrigine). FDA wants to evaluate whether other medicines in the same
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