Twenty-six Novel Therapies have been FDA-approved so far this year. Medical journals, including "The Lancet", see this as a difficult task. The Agency must maintain strict safety rules while simultaneously…
As reported on PR Newswire, the U.S. Food and Drug Administration has approved Eli Lilly and Company’s Onswik (insulin efsitora alfa-gobe), introducing a once-weekly basal insulin option for adults living…
As reported on Healio, the U.S. Food and Drug Administration has approved finerenone (Kerendia; Bayer) for adults with chronic kidney disease (CKD) associated with type 1 diabetes, marking the first…
As reported on World Pharma News, the U.S. Food and Drug Administration has granted approval to daraxonrasib, an oral RAS-targeting therapy, for adults with metastatic pancreatic adenocarcinoma who have previously…
As reported on Pharmaceutical Technology, the US Food and Drug Administration (FDA) has granted approval to PharmaEssentia’s Besremi (ropeginterferon alfa-2b-njft) for the treatment of adults with essential thrombocythaemia (ET), providing…
As reported on BioPharmaDive, Moderna captured attention this week with two major developments: a multibillion-dollar financing initiative aimed at expanding its oncology portfolio and regulatory clearance for its latest COVID-19…
RASONQUE Represents a Watershed Moment for a Disease That Has Resisted Treatment Since RAS Was Discovered as a Cancer-Causing Gene Pancreatic cancer is among the cruelest malignancies. It develops silently,…
As reported by the ICIJ, the FDA originally approved Keytruda (pembrolizumab) combined with cisplatin and gemcitabine on October 31, 2023, to treat locally advanced inoperable (unresectable) or cancer that has…
As reported on Fierce Biotech, Samsung Electronics has obtained clearance from the U.S. Food and Drug Administration (FDA) for software features that transform select Galaxy Buds earbuds into over-the-counter (OTC)…
As reported on PharmaBiz, Qiagen has received US Food and Drug Administration (FDA) clearance for its QIAstat-Dx BCID GPF Plus AMR Panel, marking the company's entry into the US bloodstream…
As reported on PR Newswire, the US Food and Drug Administration has granted Breakthrough Therapy designation to Kowa’s investigational therapy K-808 (pemafibrate) for primary biliary cholangitis (PBC), the company announced.…
As reported on Gizmodo, Samsung has announced that its Galaxy Ring will soon support an FDA-cleared sleep apnea risk detection feature, making it the first smart ring to offer a…
As reported on TechTimes, the U.S. Food and Drug Administration (FDA) has granted Premarket Approval to the TorEx® Lung Perfusion System, a new ex vivo lung perfusion (EVLP) platform developed…
As reported on MobiHealth News, the U.S. Food and Drug Administration (FDA) has awarded Breakthrough Device designation to Aurenar’s V-Link System, a noninvasive neuromodulation technology designed to help reduce cerebral…
As reported on FiercePharma, the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Vertex Pharmaceuticals’ gene-editing therapy Casgevy (exagamglogene autotemcel), allowing the treatment to be used…
As reported on Healio, new phase 3 data suggest that sonelokimab may offer durable disease control for patients with moderate to severe hidradenitis suppurativa (HS), with more than two-thirds of…
As reported on PharmaBiz, the U.S. Food and Drug Administration (FDA) has approved Lumvoa (veligrotug‑vvze), a new therapy developed by Viridian Therapeutics, for the treatment of thyroid eye disease (TED),…
As reported on FiercePharma, the U.S. Food and Drug Administration (FDA) has selected seven pharmaceutical and biotechnology companies to participate in its newly established PreCheck Pilot Program, an initiative aimed…
As reported on Healio, the U.S. Food and Drug Administration has broadened the indication for roflumilast cream 0.3% (Zoryve, Arcutis), allowing its use in children with plaque psoriasis as young…
As reported on CNET, parents and caregivers now have a new option to help monitor children’s blood sugar levels at home. The US Food and Drug Administration (FDA) has cleared…
As reported on Pharmaceutical Technology, the US Food and Drug Administration (FDA) has approved a new adjuvant treatment option for adults with clear cell renal cell carcinoma (ccRCC) at elevated…
As reported on Beckers Hospital Review, the U.S. Food and Drug Administration has authorized ensitrelvir (brand name Xocova) as the first oral antiviral indicated for post-exposure prophylaxis of COVID-19 in…
IDEAYA Biosciences and Servier announced promising Phase 2/3 trial results for darovasertib, a selective PKC inhibitor, combined with crizotinib in the treatment of metastatic uveal melanoma. According to BioSpace.com, the…
Sarepta Therapeutics has announced a significant regulatory milestone in its efforts to secure permanent FDA approval for two breakthrough Duchenne muscular dystrophy (DMD) treatments. As reported by BusinesWire.com, the company…
A decade of accumulated clinical experience with nusinersen has culminated in a significant regulatory advancement. According to Pharma Times Online, Biogen's newly approved high-dose Spinraza regimen represents a thoughtful evolution…
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