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

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

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

Aug. 18, 2026 -- BlossomHill Therapeutics, Inc. (Nasdaq: BLSM), a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BH-30643 for the treatment of adult patients with advanced or metastatic epidermal growth factor receptor (EGFR) C797S-positive non-small cell lung can

ANS-858 is being developed to reduce pathological craving associated with alcohol and other substance use disorders. Amygdala's ALDH2 inhibitor platform offers additional therapeutic opportunities in binge eating, obesity, and precision oncology. PALO ALTO, Calif., Aug. 18, 2026 /PRNewswire/ -- Amygdala Neurosciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for ANS-858, enabling the Company to adva

Hoag Hospital joins Aqua Medical's multi-center RESTORE-I study as its Irvine Hoag team, led by Dr. Jennifer Phan, delivers a milestone procedure and Dr. Phan becomes the first woman interventional endoscopist in the U.S. to perform it. Aug. 18, 2026 -- Aqua Medical, Inc., a clinical-stage medical technology company advancing Endoscopic Metabolic Restoration, today announced the treatment of the first West Coast patient (second overall in the US) in the company's FDA-approved Investigational De

Aug. 18, 2026 -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other disease areas, today announced that the National Medical Products Administration (NMPA) of China has approved the Investigational New Drug (IND) application for HBM7004 for the treatment of advanced solid tumors. HBM7004 is a novel B7H4xCD3 bispecific antibody developed using the Company's HBI