GSK
Oct 28, 2024
Pfizer’s ABRYSVO Outpaces GSK’s AREXVY with Expanded FDA Approval – But Can It Sustain the Momentum?
Pfizer’s ABRYSVO became the first and only RSV vaccine approved for use in adults under 50, offering the most extensive RSV vaccine coverage for adults. The label expansion announced on 22 October 2024 includes younger adults considered at higher risk for RSV-related lower respiratory tract disease (LRTD). &nb...
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May 17, 2024
GSK and iTeos Alliance Boosts Belrestotug Prospects in TIGIT Space
iTeos shares jump by 40%. GSK and iTeos collaboration for Belrestotug looks like a worthy wait. Hopes to ward off the negative sentiments around the volatile TIGIT space? In the ever-evolving landscape of cancer immunotherapy, the pursuit of effective treatment strategies continues to drive innovation and invest...
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Feb 27, 2024
Survodutide Phase II trial Shows Groundbreaking Results in Liver Disease; GSK Announces Positive Headline Results from EAGLE-1 Phase III Trial; Dupixent sBLA Accepted for FDA Priority Review; Biogen’s QALSODY Received Positive Opinion from CHMP; FDA Granted Orphan Drug Designation to Immune-Onc’s IO-202; Artiva Biotherapeutics’s AlloNK® in Lupus Nephritis
Survodutide Phase II trial Shows Groundbreaking Results in Liver Disease due to MASH, with Significant Improvements in Fibrosis Boehringer Ingelheim has reported that in a Phase II trial, a significant proportion of adults treated with survodutide (BI 456906), up to 83.0%, showed a notable enhancement in metabol...
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Feb 13, 2024
GSK Receives FDA Fast Track Designation for Bepirovirsen; Gilead to Acquire CymaBay Therapeutics; CSL Announces Top-line Results from the Phase III AEGIS-II Trial; Ruxoprubart Scores FDA Orphan Drug Designation for PNH Treatment; CymaBay Announces FDA Acceptance of NDA and Priority Review for Seladelpar; Biogen Received European Commission Approval for SKYCLARYS
GSK Receives FDA Fast Track Designation for Bepirovirsen in Chronic Hepatitis B GSK plc has revealed that the US Food and Drug Administration (FDA) has awarded Fast Track status to bepirovirsen, an experimental antisense oligonucleotide (ASO) designed to treat chronic hepatitis B (CHB). Fast Track designation ai...
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Jan 30, 2024
Merck’s KEYTRUDA as Adjuvant Therapy for RCC Patients; BMS Receives Positive CHMP Opinion for CAR T Cell Therapy Abecma for Multiple Myeloma; FDA Approves Dupixent for Eosinophilic Esophagitis; Juvena Receives FDA Orphan Drug Designation for JUV-161; European Commission Authorizes GSK’s Omjjara; ENHERTU Granted Priority Review in the US for for metastatic HER2-positive Solid Tumors
Merck’s KEYTRUDA Reduced the Risk of Death by 38% Versus Placebo as Adjuvant Therapy for Patients With Renal Cell Cancer (RCC) at an Increased Risk of Recurrence Following Nephrectomy Merck, also known as MSD beyond the United States and Canada, has revealed findings from the Phase III KEYNOTE-564 trial, which a...
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Nov 23, 2023
Ethicon’s ETHIZIA Hemostatic Sealing Patch; FDA Approves Medtronic’s Minimally Invasive Device to Treat Hypertension; Boston Scientific Acquires Relievant Medsystems; AstraZeneca Launched Evinova; Surmodics Announced Data of the SWING Trial; GSK Advancing the Low Carbon Ventolin Program to Phase III Trials
Ethicon Announced European Approval and Introduction of ETHIZIA™ Hemostatic Sealing Patch Used to Stop Disruptive Bleeding On November 15, 2023, Ethicon, a Johnson & Johnson MedTech company, received approval for ETHIZIA™, an adjunctive hemostat solution that has been clinically proven to achieve sustained h...
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Oct 31, 2023
Phase III RUBY Trial of Jemperli Plus Chemotherapy Updates; FDA Approves Roche’s Vabysmo for RVO; FDA Grants Priority Review to Tovorafenib Low-Grade Glioma; FDA Approves Lilly’s Omvoh; FDA Approves Toripalimab for Nasopharyngeal Carcinoma; FDA Fast Track Designation to ONCT-534 R/R mCRPC
FDA Granted Fast Track Designation to Oncternal Therapeutics’s ONCT-534 for the Treatment of Metastatic Castration-Resistant Prostate Cancer On Oct. 26, 2023, Oncternal Therapeutics, Inc. (Nasdaq: ONCT) announced that the U.S. Food and Drug Administration (FDA) has designated ONCT-534, its novel dual-acting andr...
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Sep 22, 2023
Myelofibrosis Treatment Market Heats Up with GSK’s Momelotinib Entry
On September 15, the FDA authorized GSK’s oral medication momelotinib, now known as Ojjaara, for the treatment of myelofibrosis in adults with anemia. Myelofibrosis is a disorder where normal bone marrow tissue is slowly substituted by fibrous, scar-like material. It is categorized as a form of chronic leukemia and...
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Sep 19, 2023
FDA Approves Ojjaara for Myelofibrosis; EMA Grants PRIME Designation to Iopofosine I-131; EBGLYSS Receives Positive CHMP Opinion; FDA Accepts Resmetirom NDA; FDA Fast Track Designation to KT-333 for PTCL; RedHill Announces FDA sNDA Approval for Talicia®
EBGLYSS Receives Positive CHMP Opinion for Moderate-to-Severe Atopic Dermatitis Almirall S.A. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the marketing authorization of EBGLYSS (lebrikizumab) for the treatment o...
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Aug 01, 2023
FDA Expands GSK’s Jemperli Approval; Biogen to Acquire Reata Pharma; Enhertu Shows Survival Boost in HER2+ Solid Tumors; FDA Rejects Citius’ Revived IL-2 Therapy; FDA Fast Track designation to IVS-3001 for RCC; EU Orphan Drug Designation to Biohaven’s Taldefgrobep Alfa
FDA Expands GSK’s Jemperli Approval for Endometrial Cancer GSK plc announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with mismatch repair deficient...
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