Month: January 2023

olorofim Treatment for Fungal Infections F2G Announces FDA Filing Acceptance Of New Drug Application For Olorofim For The Treatment Of Invasive Fungal Infections PRINCETON, N.J., Dec. 19, 2022 (GLOBE NEWSWIRE) — F2G Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for olorofim for

aprocitentan Treatment for High Blood Pressure Idorsia Submits a New Drug Application to the US FDA for Aprocitentan for the Treatment of Patients with Difficult-to-Control Hypertension The application includes data from the Phase 3 registration study of patients with resistant hypertension, where aprocitentan demonstrated a sustained blood pressure reduction over 48 weeks and was well-tolerated

Treatment for Geographic Atrophy Iveric Bio Announces Completion of Rolling NDA Submission to FDA for Avacincaptad Pegol for the Treatment of Geographic Atrophy PARSIPPANY, N.J.–(BUSINESS WIRE)–Dec. 20, 2022– IVERIC bio, Inc. (Nasdaq: ISEE) today announced that it has submitted to the U.S. Food and Drug Administration (FDA) the third and final part of its New

etrasimod Treatment for Ulcerative Colitis Pfizer Announces FDA and EMA Acceptance of Etrasimod Regulatory Submissions for Ulcerative Colitis Filings based on two Phase 3 trials demonstrating significant clinical remission versus placebo and safety profile consistent with previous studies NEW YORK–(BUSINESS WIRE) December 21, 2022 — Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food

Saint-Herblain (France), December 23, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that it has completed rolling submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its single-shot chikungunya vaccine candidate, VLA1553. Valneva is seeking approval of its investigational chikungunya vaccine

palovarotene Treatment for Fibrodysplasia Ossificans Progressiva Ipsen Receives Complete Response Letter for Palovarotene, an Investigational Treatment for Fibrodysplasia Ossificans Progressiva The CRL is related to the U.S. FDA’s previous request for additional information on palovarotene clinical trial data Ipsen anticipates responding to the request in the first quarter of 2023 PARIS, FRANCE, 23 December 2022

roluperidone Treatment for Schizophrenia Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia BURLINGTON, Mass., Dec. 28, 2022 (GLOBE NEWSWIRE) — Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today

vonoprazan Treatment for Erosive Esophagitis Phathom Pharmaceuticals Provides Update on New Drug Application Review of Vonoprazan for Erosive Esophagitis FLORHAM PARK, N.J., Jan. 03, 2023 (GLOBE NEWSWIRE) — Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases and disorders, today announced that the U.S. Food and

nirsevimab Treatment for Respiratory Syncytial Virus Nirsevimab US Regulatory Submission Accepted for the Prevention of RSV Lower Respiratory Tract Disease in Infants and Children up to Age 24 Months 5 January 2023 — Nirsevimab is being developed and commercialised by AstraZeneca in collaboration with Sanofi and is the first single-dose preventative option for the broad

vamorolone Treatment for Duchenne Muscular Dystrophy Santhera and ReveraGen Announce FDA Acceptance of New Drug Application for Vamorolone in Duchenne Muscular Dystrophy Pratteln, Switzerland, and Rockville, MD, USA, January 9, 2023 – Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce that the U.S. Food and Drug Administration (FDA) has accepted the new drug application

FDA Approves Leqembi (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer’s Disease Accelerated Approval is based on Phase 2 data showing a reduction in amyloid-beta plaques in early AD patients treated with Leqembi™ Treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the

FDA Approves Airsupra (albuterol/budesonide) Metered-Dose Inhaler to Reduce the Risk of Asthma Exacerbations January 11, 2023 — Airsupra (albuterol/budesonide), formerly known as PT027, has been approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. The approval

People living with type 2 diabetes can now take Rybelsus®, the first and only oral glucagon-like peptide-1 (GLP-1) analog, along with diet and exercise, as initial therapy to help lower their A1C1,2 Since its approval, Rybelsus® has been prescribed to hundreds of thousands of patients to help improve glycemic control along with diet and exercise3

FDA Approves Rykindo (risperidone) Extended-Release Injectable Suspension for the Treatment of Schizophrenia and Bipolar 1 Disorder PRINCETON, N.J., Jan. 15, 2023 /PRNewswire/ — Luye Pharma Group (Luye Pharma), an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications, today announced that the U.S. Food and Drug Administration (FDA) has approved Rykindo

Bridgewater, NJ, January 17th, 2023 — The U.S. Food and Drug Administration (FDA) has approved Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed) during the third trimester of pregnancy to help protect against pertussis in infants younger than two months of age.[1] Adacel is an FDA-approved Tdap vaccine indicated for active booster

BOTHELL, Wash.–(BUSINESS WIRE) January 19, 2023 — Seagen Inc. (Nasdaq: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tukysa (tucatinib) in combination with trastuzumab for adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. — January 19, 2023 –(BUSINESS WIRE)– BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Bruton’s tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL)

FDA Approves Brenzavvy (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes The FDA approval is based on results from a clinical program that evaluated the safety and efficacy of Brenzavvy in 23 clinical trials enrolling more than 5,000 adults with type 2 diabetes mellitus. Phase 3 studies showed Brenzavvy significantly reduced hemoglobin A1c

FDA Approves Jaypirca (pirtobrutinib) for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma Jaypirca is the first BTK inhibitor of any kind specifically approved for patients with mantle cell lymphoma previously treated with a covalent BTK inhibitor In the BRUIN Phase 1/2 trial, covalent BTK inhibitor pre-treated patients with relapsed or refractory MCL achieved

FDA Approves Orserdu (elacestrant) for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer ESR1 mutations are present in up to 40% of ER+, HER2- advanced or metastatic breast cancers. ESR1 mutations are a known driver of resistance to standard endocrine therapy, and so far, have been difficult to treat. Orserdu is

November 8, 2022 Audience: Health Care Professionals November 8, 2022 — Health care professionals should be cautious of possible xylazine inclusion in fentanyl, heroin, and other illicit drug overdoses, as naloxone may not be able to reverse its effects. FDA is aware of increasing reports of serious side effects from individuals exposed to fentanyl, heroin,

November 17, 2022 Audience: Consumers November 17, 2022 — Today, the U.S. Food and Drug Administration issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease or related conditions, such as atherosclerosis, stroke or heart failure, in violation of the Federal Food, Drug, and

November 22, 2022 Audience: Patients, Health Professionals, Pharmacy November 22, 2022 — The U.S. Food and Drug Administration (FDA) is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab). Our review of interim results from an

November 29, 2022 Audience: Patient, Health Professional, Pharmacy November 28, 2022 – Lenoir, North Carolina. Exela Pharma Sciences, LLC, (Exela) is expanding their recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. A total of 63 lots are

December 21, 2022 Audience: Patient, Health Professional, Pharmacy Baltimore, Maryland, December 21, 2022 — Lupin Pharmaceuticals Inc. is voluntarily recalling four (4) lots of Quinapril Tablets to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. To date, Lupin has

December 27, 2022 Audience: Health Professional, Pharmacy Durham, North Carolina — December 22, 2022 — Accord Healthcare, Inc. is voluntarily recalling a single lot of Daptomycin for Injection 500 mg/vial, and Daptomycin for Injection 350 mg/vial product contained in cartons imprinted with lot # R2200232 Exp: 01/2025 to the consumer/user level. This product is being

December 27, 2022 Audience: Health Professional, Pharmacy December 22, 2022 – NEW YORK, NY., Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride Injection, USP, 1.5 g/vial Single Dose Fliptop Vial, lot 33045BA, to the user level due to two visible glass particulates observed in a single vial. If administered intravenously,

December 27, 2022 Audience: Patient, Health Professional, Pharmacy December 23, 2022 – Xiamen, Fujian, GFA Production (Xiamen) Co., Ltd. is voluntarily recalling one lot of Easy Care first aid® AfterBurn ® Cream, 0.9 g single-use packets. The single use packets are sold in boxes of 10 or packaged in certain First Aid kits. This recall