AllSci News
Nicox's NCX 470 advances to FDA review as first nitric oxide-donating glaucoma therapy
Kowa Company, Ltd.'s submission of a New Drug Application (NDA) to the US FDA for NCX 470 (bimatoprost grenod), developed by France-based Nicox SA (Paris:...
Ipsen to acquire Memo Therapeutics for EUR 700m to gain first-in-class BK virus antibody
France-based Ipsen (Euronext: IPN; ADR: IPSEY) has agreed to acquire Switzerland-based Memo Therapeutics AG in a deal totaling more than EUR 700 million,...
UCSF engineers ALPPL2-targeted bispecific TCE aiming for solid cancers
University of California, San Francisco has received a USD 1.64 million National Cancer Institute R01 award to develop a bispecific T cell engager targeting...
Vistagen's fasedienol fails second Phase III social anxiety trial, clouding acute treatment strategy
Vistagen Therapeutics (Nasdaq: VTGN) reported that its PALISADE-4 Phase III trial of fasedienol for social anxiety disorder failed to meet its primary...
FDA issues second CRL to Unicycive’s oxylanthanum for CKD over manufacturing deficiencies
Unicycive Therapeutics, Inc. (Nasdaq: UNCY) received a second Complete Response Letter from the US FDA for the resubmitted New Drug Application for…
Feinstein Institutes secures NIH funding for inflammation and Alzheimer's disease research
Feinstein Institutes for Medical Research has received USD 4.9 million in NIH grants across two multi-year awards targeting acute inflammation and...
FDA’s manufacturing concerns stall Galderma’s US entry for Relfydess neuromodulator
Switzerland-based Galderma (SIX: GALD) disclosed that the US FDA has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA)…
Orca Bio’s Tregzi gets FDA nod as first allogeneic regulatory T cell therapy for transplant patients
The US FDA approved Tregzi (HSPC and T cells-vldq), developed by Orca Bio, for use in matched donor hematopoietic stem cell transplantation…
Will Therapeutics pursues first targeted drug for anorexia nervosa’s compulsive neural circuits
Montreal-based Will Therapeutics announced a government-backed research collaboration with the Douglas Hospital Research Centre to develop brain-penetrant small molecules targeting the neural…
Xellar closes USD 50m Series A to build AI-powered organ-on-chip drug discovery platform
Boston-based Xellar Biosystems has closed a USD 50 million Series A and A+ financing round to advance its organ-on-chip-based drug discovery platform, which...
METiS scores up to USD 1.62b from Deerfield's Boulevard Bio for preclinical trispecific TCE
Hong Kong-listed METiS TechBio (HKEX: 7666) has licensed its preclinical trispecific T-cell engager MTS-128 to Boulevard Bio, a Deerfield Management-backed...
FDA grants Kowa’s pemafibrate breakthrough therapy designation for PBC
Japan-based Kowa Company, Ltd. announced on June 30 that the US FDA granted Breakthrough Therapy Designation (BTD) to K-808 (pemafibrate), a selective…
Washington Uni secures USD 16.5m to expand DIAN-TU anti-tau Alzheimer's platform
The Washington University neurology department in St. Louis has received a USD 16.5 million NIA R01 renewal to continue the Dominantly Inherited Alzheimer...
Hengrui’s Heng Yi wins China approval as second EyeSol-based dry eye therapy
China’s National Medical Products Administration (NMPA) has approved Heng Yi (cyclosporine ophthalmic solution 0.1%) for the treatment of dry eye disease, marking…
FDA launches PreCheck Pilot program to accelerate domestic drug manufacturing facility approvals
Category: Regulatory Policy | Regulatory Body: FDA | Geography: United States | Instrument: Initiative launch
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