IRVINE, Calif.--(BUSINESS WIRE)--Cloudbreak Pharma Inc. a clinical-stage ophthalmology company developing innovative therapies for ocular surface diseases, today announced positive topline results from its Phase 2 clinical trial evaluating CBT-004 ophthalmic solution in patients with vascularized pinguecula and associated conjunctival hyperemia. "There is a significant unmet need for patients suffering from symptomatic pinguecula, as current therapies are largely off-label and may carry safety c

RSS Tweet Share Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) met to discuss the supplemental New Drug Application (sNDA) of REXULTI® (brexpiprazole) in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). The committee voted 1-10, concluding that the efficacy of brexpiprazole, when initiated concurrently wit

Sarepta Therapeutics said it won’t comply with an FDA request to stop shipping the company’s treatment for Duchenne muscular dystrophy, following two patient deaths, likely setting up a high-profile battle with the agency over the controversial gene therapy. Earlier this year, two patients who had taken the therapy, called Elevidys, died from liver failure. And the FDA, in a statement Friday, cited safety risks in asking the company to halt shipments of the treatment. Sarepta, in its own stateme

LONDON, July 18, 2025 /PRNewswire/ -- Virax Biolabs Group Limited (NASDAQ: VRAX) ("Virax" or the "Company"), an innovative biotechnology company focused on the detection of immune responses and diagnosis of viral diseases, announced that it received a notice from The Nasdaq Stock Market LLC ("Nasdaq") dated July 14, 2025, notifying the Company that it is not in compliance with the minimum bid price requirement as set forth under NASDAQ Listing Rule 5550(a)(2)(the "Minimum Bid Price Rule") for co

Nanopharmaceutics Inc. Announces End of Patient Recruitment of NCI Phase II Clinical Study with Lutetium Lu 177 Dotatate +/- Triapine for Neuroendocrine Tumors TRON Group Inc (OTCMKTS:TGRP) ALACHUA, FL, UNITED STATES, July 18, 2025 / EINPresswire.com / -- ALACHUA, Fla., July 18, 2025 -- Nanopharmaceutics, Inc., a clinical-stage pharmaceutical development company, today announced completion of patient enrollment in the 94 patient Phase 2 clinical study “A Phase II Randomized Control Trial of Tria

GUIDANCE DOCUMENT Draft Level 1 Guidance Not for implementation. Contains non-binding recommendations. This guidance is being distributed for comment purposes only. Submit Comments by 10/21/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date. If unable to

The FDA’s Psychopharmacologic Drugs Advisory Committee on Friday voted 10-1 against the combination of Otsuka’s Rexulti and the antidepressant Zoloft, raising concerns about a failed Phase 3 clinical trial and the fact that both parts of the combo treatment are already FDA-approved. Committee members were nearly unanimous — only the patient representative on the panel voted in favor — that this combo treatment would not add much to the already limited spread of approved drugs for PTSD, which cur

– EZMEKLY is the first and only therapy to receive marketing authorization in the EU for both adults and children (≥2 years) with NF1-PN, a rare genetic disorder with debilitating symptoms – STAMFORD, CT, USA I July 18, 2025 I SpringWorks Therapeutics, Inc., a healthcare company of Merck, announced today that the European Commission (EC) granted conditional marketing authorization for EZMEKLY ® (mirdametinib) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in pediatric

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Genentech’s supplemental Biologics License Application (sBLA) for Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for

TORONTO--(BUSINESS WIRE)--Ostia Sciences Inc., a microbiome therapeutics company developing next-generation probiotics, today announced the successful close of its seed financing round, raising CAD $1.46 million as of December 31, 2024. We are advancing our phosphorylated lantibiotic-producing probiotic technology for microbiome-based health solutions to improve oral health and the quality of life of millions of patients around the world In addition to private investment, Ostia secured over $393