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…
A major clinical trial has revealed disappointing results for setmelanotide, a promising obesity treatment, when used in patients carrying single genetic mutations associated with weight gain. The EMANATE trial, conducted…
The biotechnology sector witnessed a striking demonstration of expedited drug development this week, with Boehringer Ingelheim receiving FDA approval for an innovative lung cancer therapy in less than two months,…
The biotechnology sector experienced significant positive developments this week, with Xenon Pharmaceuticals' seizure medication achieving a decisive late-stage victory while regulatory pathways accelerated for several other promising therapies. According to…
REGENXBIO encountered a significant regulatory obstacle when the FDA issued a complete response letter regarding its biologics license application for RGX-121, an investigational gene therapy targeting mucopolysaccharidosis II (MPS II),…
Takeda Pharmaceutical has reached a significant milestone in the development of oveporexton (TAK-861), with the US Food and Drug Administration officially accepting and granting Priority Review status to the investigational…
The U.S. Food and Drug Administration has agreed to review Otsuka Pharmaceutical’s application for centanafadine, a new extended‑release therapy under investigation for attention‑deficit hyperactivity disorder (ADHD). The agency has granted…
Vera Therapeutics announced a major milestone in drug development on January 7, 2026, when the U.S. Food and Drug Administration granted Priority Review to the Biologics License Application (BLA) for…
© Copyright 2024 Patient Worthy
Sign Up With a Patient Worthy Account and Share Your Rare Story
- OR -
Make a difference, share your experiences and get paid. Opt-in and join Patient Worthy's panel for paid opportunities such as surveys, market research, patient advisory panels and more.
- OR -
Make a difference, share your experiences and get paid. Opt-in and join Patient Worthy's panel for paid opportunities such as surveys, market research, patient advisory panels and more.
