Designation offers pathway to expedite regulatory review, pending positive data, and reinforces safusidenib's potential to address significant medical needs for patients with IDH1-mutant glioma Pivotal Phase 3 SIGMA study enrollment underway Aug. 20, 2026 -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for safus

Aug. 19, 2026 -- NORROY BIOSCIENCE (NORROY), a clinical-stage biotechnology company focused on innovative targeted radiopharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has granted both Breakthrough Therapy and Fast Track designations to NORROY's 68Ga-NYM096, a potential radiopharmaceutical imaging agent targeting carbonic anhydrase Ⅸ (CAⅨ) for PET imaging of clear cell renal cell carcinoma (ccRCC). 68Ga-NYM096 is the first China-originated innovative radiopharmaceuti

Biodexa announces major milestone for its Serenta registrational Phase 3 trial in FAP 87 subjects, over 50% of target, recruited Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) (“Biodexa” or “the Company”), a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers is pleased to announce that it has exceeded the half-way point in the recruitment of subjects in its registrational Phase 3 trial of eRapa in Familial Adeno

Financing led by Company K Partners with participation from SV Investment, Flexus Partners and existing investors Proceeds to support continued clinical development of novel oncolytic immunotherapy VET3-TGI KaliVir Immunotherapeutics, Inc., a clinical-stage biotechnology company developing cutting-edge, multi-mechanistic oncolytic immunotherapy programs, today announced the closing of a $14 million extension of its Series A financing. The financing was led by Company K Partners, with participat

Clinical experience with IL-7 in immunologically vulnerable populations, including in people living with cancer or HIV, supports its potential to address impaired immune reconstitution Tolerance Bio, Inc. (“Tolerance Bio” or the “Company”), a biotechnology company focused on preserving, regenerating and modulating thymic function to address immune diseases and extend healthspan, today announced an exclusive license agreement with NeoImmuneTech (NIT, KOSDAQ: 950220.KQ) for the development and co

Ecopipam (EBS-101) is a first-in-class selective D1 (dopamine) receptor antagonist with Orphan Drug designation NDA acceptance is supported by positive Phase 3 data, which were published in JAMA Neurology, and Phase 2b data If approved, ecopipam would be the first new treatment option indicated for pediatric patients with Tourette syndrome in more than 10 years and the first novel mechanism of action in more than 50 years1 Aug. 19, 2026 -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmace

Novartis Venture Fund joins Kynexis’ existing investor syndicate, supporting the Company’s vision of becoming a leading late-stage cognition company Financing supports Phase 2 close-out activities and preparation for registrational studies of KYN-5356, an investigational, potential first-in-class KAT-II inhibitor, in cognitive impairment associated with schizophrenia (CIAS) Company has completed enrollment in ongoing Phase 2 proof-of-concept study in CIAS and remains on track to report topline

Leo Pharma on Tuesday said it will acquire the rights to dersimelagon, an experimental medicine from that’s undergoing Food and Drug Administration review, in a deal potentially worth hundreds of millions of dollars. If approved, the medicine would be the first oral treatment for two skin conditions known as erythropoietic protoporphyria and X-linked protoporphyria, Leo said. The rare genetic diseases cause severe reactions to the sun; patients can experience burning sensations, rashes, swellin

Aug. 17, 2026 -- Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it has received the final approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Pitolisant Tablets, 4.45 mg and 17.8 mg. The U.S. FDA has approved Lupin's Pitolisant Tablets, 4.45 mg and 17.8 mg, as bioequivalent to Wakix® for the indications in the approved labeling. Lupin

LUCIDITY met FDA-agreed-upon primary endpoint; avexitide demonstrated a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared to placebo (p=0.000003) LUCIDITY met all secondary endpoints showing consistent, highly statistically significant, and clinically meaningful reductions in Level 2 by self-monitoring of blood glucose (SMBG), Level 2 by CGM, and Level 3 hypoglycemic events Avexitide was generally well-tolerated with a favorable safety profile Amylyx plans t