Pharmaceuticals and Drug Development SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN Treatment for: Neurofibromatosis SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN STAMFORD, Conn., July 01, 2024 (GLOBE NEWSWIRE) — SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the Company has […] Written by Admin July 7, 2024July 7, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Monthly News Roundup – June 2024 Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on June 30, 2024. FDA Grants Expanded Approval to Skyrizi for Ulcerative Colitis On June 18th, the U.S. Food and Drug Administration (FDA) approved AbbVie’s Skyrizi (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis (UC). Skyrizi is also approved to treat adults with plaque […] Written by Leigh Ann Anderson July 1, 2024July 1, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development New study from the RVC explores malaria invasion to help develop life-saving vaccine Malaria is a deadly disease caused by the Plasmodium parasite which infects more than 200 million people a year, causing approximately 600,000 deaths annually worldwide with young children in Africa disproportionately affected. With numbers of infections expected to rise in the coming years due to growing parasite resistance to frontline anti-malarial drugs, there is a […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom June 25, 2024June 25, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development FDA Approves Skyrizi (risankizumab-rzaa) for Ulcerative Colitis NORTH CHICAGO, Ill., June 18, 2024 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved Skyrizi® (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis, making it the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohn’s disease.3 Skyrizi […] Written by Admin June 19, 2024June 19, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development New Indication for Motpoly XR (Lacosamide Extended-Release) Capsules for Primary Generalized Tonic-Clonic Seizures (Adjunctive Treatment) Generic name: lacosamideTreatment for: Seizures New Indication for Motpoly XR New Indication for Motpoly XR (Lacosamide Extended-Release) Capsules for Primary Generalized Tonic-Clonic Seizures (Adjunctive Treatment) SILVER SPRING, MD. June 7, 2024/FDA Approvals/ — Today, the U.S. Food and Drug Administration (FDA) granted Aucta Pharmaceuticals a prior approval supplemental new drug application for the use of […] Written by Admin June 13, 2024June 13, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development CDC Urges Clinicians to Remain on the Lookout for Mpox Virus Infections Medically reviewed by Drugs.com. By Elana Gotkine HealthDay Reporter THURSDAY, June 6, 2024 — Among emergency department patients evaluated for an mpox-compatible rash, the prevalence of mpox is 1.5 percent, according to research published in the June 6 issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report. Carl T. […] Written by Admin June 7, 2024June 7, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Lab Innovations 2024 to champion sustainability and innovation Lab innovations 2024 has already hit the record numbers set by last year’s show, with 80% of last year’s 202 exhibitors booking stands again for this year. Many leading brands from the industry have been confirmed to exhibit, including Waters, Sartorius, Scientific Laboratory Supplies, Veolia Water Technologies, SciMed, Alpha Laboratories Limited, IKA, PerkinElmer, Integra Biosciences, […] Written by Elsevier Ltd, The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, United Kingdom June 1, 2024June 1, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development FDA Approves Yesafili (aflibercept-jbvf), an Interchangeable Biosimilar to Eylea May 20, 2024 — The U.S. Food and Drug Administration (FDA) has approved Yesafili (aflibercept-jbvf), an interchangeable biosimilar to Eylea (aflibercept). Aflibercept products work by inhibiting vascular endothelial growth factor (VEGF) which prevents abnormal blood vessel growth within the eye. By blocking VEGF, aflibercept products can slow down or reduce damage to the retina and […] Written by Admin May 26, 2024May 26, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development Ascendis Pharma Announces Extension of U.S. Food and Drug Administration Review Period for TransCon PTH for Adults with Hypoparathyroidism Generic name: palopegteriparatideTreatment for: Hypoparathyroidism Ascendis Pharma Announces Extension of U.S. Food and Drug Administration Review Period for TransCon PTH for Adults with Hypoparathyroidism COPENHAGEN, Denmark, May 14, 2024 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food and Drug Administration (FDA) notified the Company that information submitted in response […] Written by Admin May 20, 2024May 20, 2024 Saving Bookmark this article Bookmarked
Pharmaceuticals and Drug Development All-Trigger Mortality Threat Up for Males With Low Testosterone Medically reviewed by Medicine.com. By Elana Gotkine HealthDay Reporter MONDAY, Could 13, 2024 — The danger for all-cause mortality is elevated for males with low testosterone, excessive luteinizing hormone, or very low estradiol, based on a assessment printed on-line Could 14 within the Annals of Inner Drugs. Bu B. Yeap, M.B.B.S., Ph.D., from the College […] Written by Admin May 14, 2024May 14, 2024 Saving Bookmark this article Bookmarked
Scientists capture flu viruses surfing into human cells in real time Fever, aching limbs and a runny nose — as winter returns, so too does the flu. The disease is triggered by influenza viruses, which enter our body through droplets and then infect vulnerable cells. A research team from Switzerland and Japan has taken an exceptionally close look at how this virus behaves. Using a microscopy […] Written by Admin December 6, 2025December 6, 2025 Saving Bookmark this article Bookmarked
FDA slaps hold on Denali's plans for phase 1 rare disease trial The FDA has placed a hold on Denali Therapeutics’ plans to launch a phase 1 rare disease trial, citing concerns about immune reactions to the investigational treatment recorded in preclinical mouse studies. Written by Admin December 5, 2025December 5, 2025 Saving Bookmark this article Bookmarked
Scientists capture flu viruses surfing into human cells in real time Fever, aching limbs and a runny nose — as winter returns, so too does the flu. The disease is triggered by influenza viruses, which enter our body through droplets and then infect vulnerable cells. A research team from Switzerland and Japan has taken an exceptionally close look at how this virus behaves. Using a microscopy […] Written by Admin December 6, 2025December 6, 2025 Saving Bookmark this article Bookmarked
FDA slaps hold on Denali's plans for phase 1 rare disease trial The FDA has placed a hold on Denali Therapeutics’ plans to launch a phase 1 rare disease trial, citing concerns about immune reactions to the investigational treatment recorded in preclinical mouse studies. Written by Admin December 5, 2025December 5, 2025 Saving Bookmark this article Bookmarked
Hornet-eating frog shows remarkable venom resistance A frog with an unexpectedly strong resistance to venom has been identified, and it routinely eats hornets despite the insects’ dangerous stingers. Researchers believe this species may become a useful model organism for exploring how animals develop tolerance to venom. For many people, even glimpsing a hornet’s stinger is enough to cause alarm. Yet certain […] Written by Admin December 5, 2025December 5, 2025 Saving Bookmark this article Bookmarked
Understanding PMDA Validation Rules v5.0 The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has always led the charge in ensuring the safety and efficacy of drug development. Their latest update, the PMDA Validation Rules version 5.0, which took effect on April 1, 2024, marks another significant step in this mission. Let’s break down what these new rules mean and […] Written by Admin July 10, 2024July 10, 2024 Saving Bookmark this article Bookmarked
Enhance Your SEND Submissions! Join PointCross on May 29th, 2024, at 12 PM EST / 9 AM PST for a must-attend webinar: The Most Common Issues in Preparing SEND. Ideal for professionals in data submission and regulatory compliance, this webinar offers valuable insights from our seasoned experts. Why Attend? Why PointCross? With over 10 years of experience and more […] Written by Admin May 23, 2024May 23, 2024 Saving Bookmark this article Bookmarked