GUIDANCE DOCUMENT Draft Level 1 Guidance Not for implementation.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 This guidance is being distributed for comment purposes only.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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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

Former CBER chief Peter Marks says that a decision to pause shipments of Sarepta’s gene therapy for Duchenne muscular dystrophy “makes sense at this time,” and that there could be broader issues with aspects of the treatment. Marks, who left the FDA earlier this year, controversially helped push Sarepta’s therapy to approval in 2024, overruling two of his top deputies who felt the treatment should be rejected and that the company should run an additional clinical trial. “Given the recent develop

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Names: Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir, Filter, Manometer and 7 ft Oxygen Tubing Unique Device Identifier (UDI)/Model: Each: 10884389164822, Case: 40884389164823 Lot/Serial Numbers: 526782, 526790, 526796, 526797, 526798, 526800,

FRANKLIN, Tenn.--(BUSINESS WIRE)--Acadia Healthcare Company, Inc. (NASDAQ: ACHC) today announced that it will release its second quarter 2025 results on Tuesday, August 5, 2025, after the close of the market. Acadia will conduct a conference call with institutional investors and analysts at 9:00 a.m. ET on Wednesday, August 6, 2025. A live broadcast of the conference call will be available at www.acadiahealthcare.com in the “Investors” section of the website. The webcast of the conference call w

For Immediate Release: July 18, 2025 Media Contact: Kyle Casteel - Media Lead Communication Office │ Department of Health 802-863-7280 │ [email protected] New Opioid Use Disorder Treatment Hub Now Open in Bennington Grand opening event planned for July 23 WATERBURY, VT — A new treatment hub for opioid use disorder is now open in Bennington, marking a significant expansion to the state's network of services for people recovering from substance misuse. The site is operated by BayMark Health Servic

GA, UNITED STATES, July 18, 2025 / EINPresswire.com / -- Recently, a piece of perspective explores the potential of combining artificial intelligence (AI) and engineered stem cells to combat ovarian aging, a major cause of female infertility. By leveraging an innovative AI tool named OvaRePred to predict ovarian reserve and identify molecular hallmarks of aging, researchers developed ovarian rescue cells (OvaResCells)—customized stem cells enhanced with gene editing to rejuvenate ovarian functio