Latest News for: fda

Edit

Alterity Therapeutics Receives Positive FDA Feedback Following Second Type C Meeting on ATH434 Phase 3 Program in Multiple System Atrophy (Alterity Therapeutics Ltd)

Public Technologies 27 Apr 2026
). The text version of this document is not available ... Disclaimer ... (noodl. 131221526) .
Edit

OSE Immunotherapeutics Welcomes FDA Orphan Drug Designation Granted to Pegrizeprument (VEL-101) for Prevention of Organ ...

Norfolk Daily News 27 Apr 2026
Nantes, France, April 27, 2026 – 7.30am CEST - OSE Immunotherapeutics SA (ISIN. FR0012127173; Mnemo. OSE), today ... .
Edit

Motif Neurotech Receives FDA Approval to Begin First Clinical Trial of its Therapeutic BCI for ...

The Milton Standard Journal 27 Apr 2026
HOUSTON--(BUSINESS WIRE)--Apr 27, 2026-- ....
Edit

Intellia Therapeutics Initiates Rolling Submission of Biologics License Application to FDA for Lonvoguran Ziclumeran (lonvo-z) ...

Nasdaq Globe Newswire 27 Apr 2026
Expect to complete BLA submission in second half of 2026; anticipate launch in first half of 2027, if approved. Expect to complete BLA submission in second half of 2026; anticipate launch in first half of 2027, if approved ... .
Edit

Alterity Therapeutics Receives Positive FDA Feedback Following Second Type C Meeting on ATH434 Phase 3 ...

Nasdaq Globe Newswire 27 Apr 2026
Food and Drug Administration (FDA) regarding its planned Phase 3 development program for ATH434 in Multiple System ...
Edit

Clearmind Medicine Announces Evaluation of its Psychedelic-Based Treatment (MEAI) for Potential FDA Breakthrough Therapy Designation

Nasdaq Globe Newswire 27 Apr 2026
Positive clinical results from Alcohol Use Disorder clinical trial may strengthen potential for eligibility for Breakthrough Therapy Designation ... .
Edit

Eateries must declare use of paneer or cheese analogue on menus: Maharashtra FDA

The Hindu 27 Apr 2026
Rule, enforced from March 25, follows complaints that cheese analogue is being sold as paneer ....
Edit

Alterity Therapeutics Receives Positive FDA Feedback Following Second Type C Meeting on ATH434

Caledonian Record 27 Apr 2026
... – – End-of-Phase 2 meeting with FDA remains ....
Edit

Arcutis Submits Supplemental New Drug Application to the FDA for ZORYVE® (roflumilast) Cream

Caledonian Record 27 Apr 2026
Submission supported by data from INTEGUMENT-INFANT ...
Edit

Terns Pharmaceuticals Announces FDA Breakthrough Therapy Designation Granted to TERN-701 for

Caledonian Record 27 Apr 2026
Food and Drug Administration (FDA) granted Breakthrough ...
Edit

TytoCare Secures FDA De Novo for First AI-Powered Eardrum Analysis

The Facts 27 Apr 2026
TytoCare is the first company to receive an FDA De Novo-classified AI solution for analyzing otoscopy videos, establishing a new regulatory category in ENT diagnostic aid, with patient access enabled through its Smart Checkup capabilities ....
Edit

Jazz Pharmaceuticals Announces FDA Acceptance and Priority Review of Supplemental Biologics License Application for Ziihera® ...

The Facts 27 Apr 2026
Prescription Drug User Fee Act (PDUFA) date set for August 25, 2026 ....
Edit

Boston Cell Standards Enters Final Phase of FDA MDDT Program to Qualify First-in-Industry Platform to ...

The Galveston Daily News 27 Apr 2026
BOSTON--(BUSINESS WIRE)--Apr 27, 2026-- ....
Edit

Oncolytics Aligns with FDA on Planned Pivotal Anal Cancer Study

Nasdaq Globe Newswire 27 Apr 2026
Oncolytics Biotech announced Type C meeting with the FDA aligning on the design of clinical study to support approval of pelareorep in patients with SCAC ... .
Edit

Arcutis Submits Supplemental New Drug Application to the FDA for ZORYVE� (roflumilast) Cream 0.05% to ...

Nasdaq Globe Newswire 27 Apr 2026
Food and Drug Administration (FDA) seeking to expand the indication for ZORYVE� (roflumilast) cream ...

Article Search

tools
×
×
×
×