Drugs

September 8, 2021 Audience: Health Professional, Pharmacy  September 08, 2021 — Wilmington, MA, Azurity Pharmaceuticals, Inc. (“Azurity”) is voluntarily recalling one lot of Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit (“Firvanq®”) to the consumer level, as some products in the affected lot have been found to incorrectly contain a First Omeprazole (FIRST-PPI)
0 Comments
toripalimab Treatment for Nasopharyngeal Carcinoma Coherus and Junshi Biosciences Announce Completion of Rolling BLA Submission to U.S. FDA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma SHANGHAI, China, and REDWOOD CITY, Calif., Sept. 01, 2021 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. (“Coherus”, Nasdaq:
0 Comments
Treatment for Wilson’s Disease FDA Acceptance for Filing of New Drug Application (NDA) for Trientine Tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s Disease NDA supported by positive data from Phase 3 CHELATE clinical trial TETA 4-HCl previously granted Orphan Drug Designation for first-line treatment of Wilson’s Disease Paris, France – 02 September 2021 – Orphalan
0 Comments
FDA Approves Trudhesa (dihydroergotamine mesylate) Nasal Spray for the Acute Treatment of Migraine SEATTLE, Sept. 03, 2021 (GLOBE NEWSWIRE) — Impel NeuroPharma, Inc. (NASDAQ: IMPL), a commercial-stage biopharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, with an initial focus on the central nervous system, today announced that the
0 Comments
Treatment for Bacterial Vaginosis Daré Bioscience Announces FDA Acceptance and Priority Review of New Drug Application for DARE-BV1 for the Treatment of Bacterial Vaginosis SAN DIEGO, Aug. 09, 2021 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that the U.S. Food and Drug Administration (FDA) accepted for filing
0 Comments
tapinarof Treatment for Plaque Psoriasis, Atopic Dermatitis Dermavant Announces FDA Acceptance for Filing of New Drug Application (NDA) for Tapinarof Cream for the Treatment of Adults with Plaque Psoriasis LONG BEACH, Calif. & BASEL, Switzerland–(BUSINESS WIRE) August 10, 2021 –Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today
0 Comments
CAMBRIDGE, Mass. & BEIJING, September 01, 2021–(BUSINESS WIRE)–BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that Brukinsa (zanubrutinib) has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). “We are delighted by
0 Comments
FDA Approves Invega Hafyera (paliperidone palmitate) for Twice-Yearly Treatment for Adults with Schizophrenia TITUSVILLE, N.J., Sept. 1, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic Invega Hafyera (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia
0 Comments
palovarotene Treatment for Fibrodysplasia Ossificans Progressiva Ipsen Announces Withdrawal of Palovarotene NDA, Confirming Intention to Resubmit Following Additional Data Analyses Paris (France), Friday 13 August, 2021 – Ipsen (Euronext: IPN; ADR: IPSEY) today announced, following very recent discussions with the U.S. Food and Drug Administration (FDA), withdrawal of the New Drug Application (NDA) for palovarotene. This
0 Comments
September 1, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy This information is an update to the FDA Drug Safety Communication issued on February 4, 2021. FDA also previously communicated about the safety clinical trial with Xeljanz, Xeljanz XR (tofacitinib) in February 2019 and July 2019 What safety concern is FDA announcing? Based on a completed
0 Comments
Treatment for Bladder Cancer Sesen Bio Receives Complete Response Letter from FDA for Vicineum (oportuzumab monatox-qqrs) CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aug. 13, 2021– Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding
0 Comments
Tibsovo is the first and only targeted therapy approved for patients with previously treated IDH1-mutated cholangiocarcinoma BOSTON, Aug. 25, 2021 /PRNewswire/ — Servier Pharmaceuticals, a growing leader in oncology committed to bringing the promise of tomorrow to the patients we serve, announced today that the U.S. Food and Drug Administration (FDA) approved Tibsovo® (ivosidenib tablets)
0 Comments
Treatment for Prevention of COVID-19 Pfizer and BioNTech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of Comirnaty in Individuals 16 and Older New Phase 3 data show booster (third) dose of Comirnaty induces significant SARS-CoV-2 neutralizing antibody titers and demonstrated a favorable safety and tolerability profile SARS-CoV-2 neutralizing
0 Comments
ATLANTA, Aug. 30, 2021 /PRNewswire/ — UCB announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Briviact (brivaracetam) CV tablets, oral solution, and injection to treat partial-onset seizures in patients as young as one month of age.2 This is the first time that the IV formulation of Briviact
0 Comments
elamipretide Treatment for Barth Syndrome Stealth BioTherapeutics Submits Elamipretide New Drug Application to FDA for Treatment of Barth Syndrome BOSTON, Aug. 24, 2021 /PRNewswire/ – Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced the submission of a New Drug Application (NDA)
0 Comments
PRINCETON, N.J.–(BUSINESS WIRE) August 20, 2021 — Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 240 mg every two weeks or 480 mg every four weeks (injection for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at
0 Comments
Treatment for Prevention of COVID-19 Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for its COVID-19 Vaccine Final blinded analysis of Phase 3 COVE study of the Moderna COVID-19 vaccine shows 93% efficacy; efficacy remains durable through six months after second dose CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aug. 25, 2021– Moderna, Inc. (Nasdaq: MRNA),
0 Comments
FDA Approves Korsuva (difelikefalin) Injection for the Treatment of Moderate-to-Severe Pruritus in Hemodialysis Patients STAMFORD, Conn. and ST. GALLEN, Switzerland, Aug. 23, 2021 (GLOBE NEWSWIRE) — Cara Therapeutics (Nasdaq: CARA) and Vifor Pharma today announced that the U.S. Food and Drug Administration (FDA) has approved Korsuva (difelikefalin) for injection for the treatment of moderate-to-severe pruritus
0 Comments
mitapivat Treatment for Pyruvate Kinase Deficiency Agios Announces FDA Acceptance and Priority Review of New Drug Application for Mitapivat for Treatment of Adults with Pyruvate Kinase Deficiency CAMBRIDGE, Mass., Aug. 17, 2021 (GLOBE NEWSWIRE) – Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism developing and delivering innovative treatments for genetically defined diseases, today announced
0 Comments
FDA Approves Skytrofa (lonapegsomatropin-tcgd) for the Once-Weekly Treatment of Pediatric Growth Hormone Deficiency COPENHAGEN, Denmark, Aug. 25, 2021 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to potentially create new treatments that make a meaningful difference in patients’ lives, today announced that the U.S. Food and
0 Comments
Treatment for Major Depressive Disorder Axsome Therapeutics Provides Update on the New Drug Application for AXS-05 for the Treatment of Major Depressive Disorder NEW YORK, Aug. 23, 2021 (GLOBE NEWSWIRE) – Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA)
0 Comments
First ready-to-use liquid glucagon available in a single-dose vial and syringe kit for rescue Gvoke HypoPen®, Gvoke® PFS, and Gvoke® Kit – three different administration options to accommodate patients’ preferences Gvoke Kit eliminates the need for reconstitution Gvoke Kit availability anticipated in early Q1 2022 CHICAGO–(BUSINESS WIRE) August 23, 2021 –Xeris Pharmaceuticals, Inc. (Nasdaq: XERS),
0 Comments
FDA Approves Comirnaty (Pfizer-BioNTech COVID-19 Vaccine) to Prevent COVID-19 Individuals 16 Years and Older Comirnaty is the first COVID-19 vaccine to be granted FDA approval Approval is based on a comprehensive submission package including six-month efficacy and safety data after second dose More than 1.2 billion Pfizer-BioNTech doses have been delivered to more than 120
0 Comments
FDA Approves TicoVac (tick-borne encephalitis vaccine) to Prevent Tick-Borne Encephalitis (TBE) NEW YORK–(BUSINESS WIRE) August 13, 2021 — Pfizer Inc. (NYSE:PFE) today announced that the U.S. 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
0 Comments
August 16, 2021 Audience: Consumer August 16, 2021 — Pfizer is voluntarily recalling an additional four lots of Chantix 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 Daily Intake (ADI) level. Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential
0 Comments
News FDA Alerts Jongu 4308 Issues Voluntary Nationwide Recall of Hydro Pineapple Burn Due to the Presence of Undeclared Sibutramine August 11, 2021 Audience: Consumer August 11, 2021 — Houston, Texas, eBay Seller ID: jongu 4308 is voluntarily recalling all lots of Hydro Pineapple Burn to consumer level. FDA analysis has found the product to
0 Comments
DUBLIN, Aug. 12, 2021 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of idiopathic hypersomnia in adults.1 The company plans to make Xywav available to patients with idiopathic hypersomnia later this year following
0 Comments