Drugs

CAMBRIDGE, Mass., Feb. 01, 2021 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has approved a new intramuscular (IM) injection route of administration for Plegridy® (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis (MS). The new IM administration offers people living with relapsing

Treatment for Migraine Impel NeuroPharma Announces U.S. Food & Drug Administration Acceptance of New Drug Application for INP104 for the Acute Treatment of Migraine SEATTLE, January 20, 2021 — Impel NeuroPharma, a late-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s 5O5(b)(2) New Drug Application

odevixibat Treatment for Progressive Familial Intrahepatic Cholestasis (PFIC) Albireo Announces U.S. FDA Acceptance of New Drug Application for Odevixibat BOSTON, Jan. 25, 2021 (GLOBE NEWSWIRE) – Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for

sulopenem Treatment for Bacterial Infection Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem DUBLIN, Ireland and CHICAGO, Jan. 25, 2021 (GLOBE NEWSWIRE) — Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug

January 27, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy January 27, 2021 — Meitheal Pharmaceuticals, Inc. (“Meitheal”), announced today that it is voluntarily recalling one (1) lot of Cisatracurium Besylate Injection, USP 10mg per 5mL to the user level. The decision to recall the product was made after a product complaint revealed that a portion

PRINCETON, N.J.–(BUSINESS WIRE) January 22, 2021– Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 240 mg (injection for intravenous use) every two weeks or 480 mg every four weeks in combination with Cabometyx (cabozantinib) 40 mg once daily tablets was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment

January 26, 2021 Audience: Consumer January 26, 2021 — As part of the U.S. Food and Drug Administration’s continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the agency has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation

FDA Approves Lupkynis (voclosporin) for Adult Patients with Active Lupus Nephritis VICTORIA, British Columbia & ROCKVILLE, Md.– January 22, 2021 — Aurinia Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN).

FDA Approves Cabenuva (cabotegravir and rilpivirine) Long-Acting Injectable HIV Treatment and Vocabria (cabotegravir) Oral HIV Treatment London, 21 January 2021 – ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) approved Cabenuva, the first

BOSTON–(BUSINESS WIRE)–December 21, 2020 — Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) expanded the eligibility for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include people with cystic fibrosis (CF) ages 12 years and older with certain mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that are responsive to

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction KENILWORTH, N.J.–(BUSINESS WIRE)– 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 Verquvo, a soluble guanylate cyclase (sGC) stimulator, to reduce the risk of cardiovascular death and heart failure hospitalization

Treatment for Hypogonadism — Male Marius Pharmaceuticals Submits New Drug Application to U.S. FDA for Kyzatrex Next-generation Oral Testosterone Replacement Therapy in Male Patients with Hypogonadism Raleigh, N.C., Jan. 5, 2021 — Marius Pharmaceuticals, a specialty pharmaceutical company focusing on treating conditions that are primarily associated with testosterone deficiency, today announced that it has submitted

NEW YORK–(BUSINESS WIRE) January 14, 2021 — Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Xalkori® (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL)

TOKYO & MUNICH & BASKING RIDGE, N.J.–(BUSINESS WIRE) January 15, 2021 — Daiichi Sankyo Company, Ltd.  (hereafter, Daiichi Sankyo) and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based

January 15, 2021 Audience: Health Care Professionals January 15, 2021 – The U.S. Food and Drug Administration is alerting health care professionals to labeling updates for the preparation of vinca alkaloids, a group of chemotherapy agents that includes vincristine sulfate injection, vinblastine sulfate (for) injection, and vinorelbine tartrate injection. To reduce the potential for unintended intrathecal

January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of Darzalex Faspro® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL)

surufatinib Treatment for Neuroendocrine Carcinoma Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors Hong Kong, Shanghai, & Florham Park, NJ: Monday, December 28, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that it has initiated the filing of a New Drug Application (“NDA”) to

somatrogon Treatment for Pediatric Growth Hormone Deficiency US FDA Accepts Regulatory Submission from Pfizer and OPKO for Review of Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency  NEW YORK & MIAMI–(BUSINESS WIRE) Monday, January 04, 2021 — Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the US Food and

January 8, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy January 08, 2021 — Fresenius Kabi USA is voluntarily recalling a single lot of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. Particulate matter was found in reserve

December 31, 2020 Audience: Consumer, Patient, Health Professional, Pharmacy December 31, 2020 Precision Dose, Inc. is voluntarily recalling all lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Unit Dose Cups bearing an expiration date from 1/31/2021 – 02/28/2022 (see specific lots below) to the consumer level. Precision Dose, Inc. was notified by the manufacturer

reltecimod Treatment for Organ Dysfunction or Failure in Patients with Necrotizing Soft Tissue Infection Atox Bio Announces FDA Acceptance to File the NDA for Reltecimod to Treat Suspected Organ Dysfunction or Failure in Patients with Necrotizing Soft Tissue Infection (“Flesh-Eating Disease”) DURHAM, N.C. and NESS ZIONA, Israel, Dec. 10, 2020 /PRNewswire/ – Atox Bio today announced that the U.S. Food and

January 4, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy January 4, 2021 — Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been

News FDA Alerts Essaar Inc. Issues Voluntary Nationwide Recall of Rubbing Alcohol Contaminated with Methanol January 4, 2021 Audience: Consumer January 4, 2021 — Essaar Inc. is voluntarily recalling lot 200528303 of Soho Fresh 70% Rubbing Alcohol in 33.81 oz. clear plastic bottles to the consumer level. FDA analysis of the product revealed it is

17 December 2020 –  GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy. Lupus nephritis is a serious inflammation of the kidneys caused by systemic lupus erythematosus (SLE), the most common form

Treatment for Molluscum Contagiosum Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum WEST CHESTER, PA – Dec. 23, 2020 (GLOBE NEWSWIRE) – Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it has resubmitted the

RALEIGH, N.C., December 21, 2020 – Merz Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA) for the treatment of patients aged 2 years and older with chronic sialorrhea, or drooling. Xeomin is the first and only FDA-approved neuromodulator with this indication and

Treatment for Chronic Kidney Disease-Associated Pruritus Cara Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Korsuva Injection in Hemodialysis Patients with Moderate-to-Severe Pruritus STAMFORD, Conn., Dec. 28, 2020 (GLOBE NEWSWIRE) — Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus

WALTHAM, Mass., Dec. 22, 2020 (GLOBE NEWSWIRE) — Sobi™, an international biopharmaceutical company dedicated to rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Kineret (anakinra) for the treatment of deficiency of IL-1 receptor antagonist (DIRA). DIRA is an ultra-rare, autoinflammatory disease caused by