News

Urcosimod has received FDA fast track designation for neuropathic corneal pain, enabling expedited regulatory processes and ...
OKYO Pharma Limited (NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which is developing urcosimod ...
LUND, SE / ACCESS Newswire / April 29, 2025 /BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a biotech ...
INX-315, a CDK2 inhibitor, gained FDA fast track status in CCNE1-positive platinum-resistant/refractory ovarian cancer.
Fast Track designation highlights potential of INX-315 to address unmet need for patients with recurrent advanced/metastatic ...
INX-315, a CDK2 inhibitor, received FDA fast track designation for patients with CCNE1-amplified platinum-resistant ovarian ...
The FDA has issued a Complete Response Letter to Telix Pharmaceuticals regarding the NDA for TLX101-CDx for the imaging of gliomas.
US FDA grants fast track designation to OKYO Pharma’s urcosimod to treat neuropathic corneal pain: London Saturday, May 3, 2025, 17:00 Hrs [IST] OKYO Pharma Limited, an ophthalm ...
The FDA granted fast track designation to urcosimod to treat neuropathic corneal pain, according to a press release from Okyo Pharma. Urcosimod, formerly called OK-101, is a “lipid conjugated chemerin ...
Drugs receiving FTD may also be eligible for Accelerated Approval and Priority Review if relevant criteria are met. More information on the FDA's Fast Track process is available here.