Drugs

tenapanor Treatment for Hyperphosphatemia of Renal Failure Ardelyx Provides Regulatory Update on New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis FREMONT, Calif. and WALTHAM, Mass., July 19, 2021 /PRNewswire/ – Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment

NORTH CHICAGO, Ill., July 23, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved Dalvance® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. Dalvance is the first single-dose option administered as a 30-minute intravenous (IV) infusion for

News FDA Alerts HIS Issues Voluntary Nationwide Recall of Miss Slim Due to the Presence of Undeclared Sibutramine July 22, 2021 Audience: Consumer July 22, 2021 — Palisades Park, NJ, HIS is voluntarily recalling all lots and all presentations of Miss Slim (10 count & 30 count capsules) to the consumer level. HIS decided to

Treatment for Seizure Clusters Aquestive Therapeutics Resubmits New Drug Application for Libervant (diazepam) Buccal Film WARREN, N.J., June 24, 2021 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today the resubmission of its New Drug

PARAMUS, N.J.–(BUSINESS WIRE) July 20, 2021 –The U.S. Food and Drug Administration (FDA) has granted approval to Octapharma USA for Octagam® 10% [Immune Globulin Intravenous (Human)], the first and only intravenous immunoglobulin (IVIg) to be indicated for the treatment of adult dermatomyositis, a rare immune-mediated inflammatory disease. The FDA approval is based on the results

teplizumab Treatment for Prevention of Type 1 Diabetes Provention Bio Receives Complete Response Letter (CRL) to Biologics License Application (BLA) for Teplizumab for the Delay of Clinical Type 1 Diabetes (T1D) in At-Risk Individuals RED BANK, N.J., July 6, 2021 /PRNewswire/ – Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today

FDA Approves Bylvay (odevixibat) for the Treatment of Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC) BOSTON, July 20, 2021 (GLOBE NEWSWIRE) – Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today announced U.S. Food & Drug Administration (FDA) approval of Bylvay (odevixibat), the first drug approved for the treatment of pruritus in

Treatment for Seizure Clusters Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant (diazepam) Buccal Film WARREN, N.J., July 19, 2021 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that

July 19, 2021 — The US Food and Drug Administration (FDA) has approved fexinidazole as the first all-oral treatment for both stages of the Trypanosoma brucei gambiense form of sleeping sickness (Human African trypanosomiasis) in patients 6 years of age and older and weighing at least 20 kg.Fexinidazole was developed as part of an innovative

July 20, 2021 Audience:  Patient, Health Professional, Pharmacy  What safety information is FDA announcing? The U.S. Food and Drug Administration (FDA) is requesting removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients. Despite the change, most patients should stop statins once they learn they are pregnant. We have conducted a comprehensive

roxadustat Treatment for Anemia Associated with Chronic Renal Failure Status on FDA Advisory Committee Vote on Roxadustat in Anemia of Chronic Kidney Disease 16 July 2021 — The Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 13 to 1 that the benefit-risk profile of roxadustat does not support approval

FDA Approves Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Adults KENILWORTH, N.J.–(BUSINESS WIRE)– (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive

July 19, 2021 Audience: Consumer July 19, 2021 — Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and eight lots of a Chantix kit of 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable

FDA Approves Rezurock (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD) NEW YORK, NY / ACCESSWIRE / July 16, 2021 / Kadmon Holdings, Inc. (Nasdaq:KDMN) today announced that the U.S. Food and Drug Administration (FDA) has approved Rezurock™ (belumosudil) 200 mg once daily (QD) for the treatment of adult and pediatric patients

tezepelumab Treatment for Asthma Tezepelumab Granted Priority Review By U.S. FDA THOUSAND OAKS, Calif., July 7, 2021 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. Tezepelumab is being developed by Amgen in collaboration with AstraZeneca. The FDA grants Priority

Regular Approval Based on Overall Survival Results from Confirmatory EV-301 Trial First and Only FDA-Approved Therapy for Urothelial Cancer Patients Who Are Cisplatin-Ineligible and Have Previously Received One or More Prior Therapies, Based on Cohort 2 of Pivotal EV-201 Trial TOKYO and BOTHELL, Wash., July 9, 2021 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President

July 14, 2021 Audience: Consumer NEW BRUNSWICK, N.J., JULY 14, 2021 – Johnson & Johnson Consumer Inc. (JJCI) is voluntarily recalling all lots of five Neutrogena® and Aveeno® aerosol sunscreen product lines to the consumer level. Internal testing identified low levels of benzene in some samples of the products. Consumers should stop using the affected

News FDA Alerts Initial Results of Near Real-Time Safety Monitoring of COVID-19 Vaccines in Persons Aged 65 Years and Older July 9, 2021 Audience:  Patient, Health Professional, Pharmacy  July 9, 2021 — FDA has routinely been using screening methods to monitor the safety of COVID-19 vaccines and to evaluate potential adverse events of interest (AEI)

FDA Approves Kerendia (finerenone) for the Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes WHIPPANY, N.J.– July 9, 2021 (BUSINESS WIRE)– Bayer announced today the United States (U.S.) Food and Drug Administration (FDA) has approved Kerendia (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained

July 7, 2021 Audience: Health Professional, Pharmacy  July 7, 2021 – The U.S. Food and Drug Administration (FDA) is requiring safety labeling changes to the prescribing information for the class of hydroxyethyl starch products to amend the Boxed Warning to warn about the risk of mortality, kidney injury, and excess bleeding. FDA is also requiring related

lenacapavir Treatment for HIV Infection Gilead Submits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options FOSTER CITY, Calif.–(BUSINESS WIRE)–Jun. 28, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the company completed submission of a New Drug Application

BALTIMORE, July 1, 2021 /PRNewswire/ –Lupin Pharmaceuticals, Inc., the U.S. based wholly-owned subsidiary of global pharma major Lupin Limited (Lupin), announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental New Drug Application (sNDA) to expand the use of Solosec (secnidazole) to include the treatment of trichomoniasis in adults. Trichomoniasis

July 2, 2021 Audience:  Patient, Health Professional, Pharmacy  July 2, 2021 –  FDA is alerting patients and health care professionals to Pfizer’s voluntary recall of nine lots of the smoking cessation drug, varenicline (brand name Chantix), to the warehouse level. The company is recalling varenicline because it may contain levels of a nitrosamine impurity, called

FDA Approves Rylaze for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma DUBLIN, June 30, 2021 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) approval of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute

July 1, 2021 Audience: Health Professional, Pharmacy July 1, 2021 — Teva Pharmaceuticals has initiated a voluntary recall of lot 31328962B of Topotecan Injection 4 mg/4 mL (1 mg/mL), to the retail/institutional level in the United States. This voluntary recall was initiated based on a complaint received from a pharmacy after a single glass particle

FDA Approves Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma DUBLIN, June 30, 2021 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) approval of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a multi-agent chemotherapeutic regimen for

Treatment for Prevention of Cisplatin-Induced Ototoxicity Fennec Pharmaceuticals Announces FDA Acceptance of New Drug Application Resubmission for Pedmark Research Triangle Park, NC, June 22, 2021 – Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the resubmission of its

FDA Approves Soaanz (torsemide) for Edema Treatment in Patients with Heart Failure and Renal Disease VIENNA, VA. (PRWEB) JUNE 21, 2021 Sarfez Pharmaceuticals announced today approval by the U.S. Food and Drug Administration (FDA) of the Virginia-based company’s New Drug Application for Soaanz, a once-a-day improved formulation of the loop diuretic torsemide. The approved drug