As reported by Pharmaceutical Technology, Alkermes has announced that its investigational therapy alixorexton has received orphan drug designation from both US and European regulators, marking a significant regulatory milestone for…
As reported on PharmaBiz, AstraZeneca has announced that the US Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for ravulizumab (Ultomiris) for the…
As reported on MedCity News, the U.S. Food and Drug Administration (FDA) has issued draft guidance encouraging the thoughtful use of Bayesian statistical approaches in clinical trials, marking a notable…
Emerging evidence, as reported by the American Academy of Ophthalmology, suggests that glycemic surveillance should be considered for all patients undergoing teprotumumab therapy for thyroid eye disease (TED), regardless of…
Madrid, June 5th, 2026 The Dravet Syndrome Foundation received the Merck Innovation Talent Award for a scientific publication regarding a tool that assesses neuropsychiatric issues associated with the disease. The…
As reported on Business Wire, TearSolutions, a clinical-stage biotechnology company focused on ophthalmic therapies, has announced key regulatory and clinical progress for its investigational drug Lacripep® in the treatment of…
In a notable update for dermatologic and consumer health, the U.S. Food and Drug Administration (FDA) released a press statement disclosing their authorization of the use of bemotrizinol as an…
As reported on Becker's Hospital Review, the U.S. Food and Drug Administration’s launch of a real-time clinical trial model marks a notable shift in how oncology research is conducted and…
As reported on Business Wire, Onchilles Pharma has announced the first patient dosing in a Phase 1/2 clinical trial evaluating its investigational therapy, N17350, in individuals with advanced solid tumors.…
As reported on BioSpace, Eli Lilly is moving closer to expanding the use of its oral GLP‑1 receptor agonist orforglipron, marketed as Foundayo, into type 2 diabetes (T2D), following encouraging…
As reported on PharmaBiz, Omnix Medical has reached a key clinical milestone with the initiation of patient dosing in a phase II study of its lead antimicrobial candidate, OMN6. The…
As reported on STAT News, a novel combination of investigational therapies from Tango Therapeutics and Revolution Medicines is generating cautious optimism after demonstrating notable tumor responses in an early-stage clinical…
Merck and Gilead Sciences reported contrasting late-stage outcomes on Monday, pairing a promising advance in HIV treatment with the discontinuation of a high-profile lung cancer trial after underwhelming survival results.…
As reported on Business Wire, Stanford Medicine Cancer Center has reported a significant milestone in radiation oncology, completing the world’s first patient treatment using a compact upright proton therapy system.…
As reported by The Manila Times, MediciNova has announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for a new patent application involving its investigational…
According to a recent report on BioSpace, Otsuka Pharmaceutical’s investigational therapy Voyxact is gaining momentum in IgA nephropathy (IgAN) after new Phase 3 results showed meaningful preservation of kidney function,…
As reported in BioPharmaDive, the U.S. Food and Drug Administration (FDA) has postponed its decision on camizestrant, an experimental oral therapy for breast cancer being developed by AstraZeneca, following a…
As reported on PharmaBiz, HAYA Therapeutics has reached an early clinical milestone with its lead investigational therapy, HTX-001, announcing that the first cohort of participants has been enrolled and treated…
As reported on PharmaBiz, Infex Therapeutics has announced encouraging results from a phase IIa clinical study of RESP‑X, an investigational monoclonal antibody being developed for patients with non‑cystic fibrosis bronchiectasis…
As reported on FiercePharma, Cingulate Therapeutics has encountered a regulatory setback in its effort to bring its lead attention-deficit/hyperactivity disorder (ADHD) therapy to market, after the U.S. Food and Drug…
As reported on PharmaBiz, new findings from the phase 2 ElevAATe trial suggest that the investigational agent efdoralprin alfa may represent a meaningful advance in the treatment of alpha-1 antitrypsin…
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…
As reported on BioSpace, the U.S. Food and Drug Administration (FDA) has granted priority review to BridgeBio Pharma’s investigational therapy, BBP-418, marking a key regulatory milestone for a condition that…
As reported by PharmaBiz, Japan’s Ministry of Health, Labour and Welfare (MHLW) has broadened the approved use of GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, to cover adults aged 18–49…
According to a recent article on PharmaBiz, HAYA Therapeutics has announced the completion of dosing in the first cohort of its phase 1 clinical study evaluating HTX-001, an investigational RNA-targeting…
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