ALK (ALKB:DC / OMX: ALK B) today announced the first market launch of EURneffy® 2 mg (the trade name for neffy® in the EU) in Germany. The launch of this first ever adrenaline nasal spray for timely emergency treatment of anaphylaxis represents a significant milestone for adults and children (≥30 kg) experiencing potentially life-threatening allergic reactions. With an intuitive, needle-free design, EURneffy® can help more people confidently use adrenaline when it matters most, supporting fast,

New clinical trial data with Bryn Pharma’s second-generation epinephrine nasal spray expected in Q3 2025 The trial employs an upgraded two-spray nasal spray device providing additional reliability and user experience enhancements Trial includes evaluation of pharmacokinetics (“PK”) and pharmacodynamics (“PD”) for an innovative two-doses-in-one device (“dual-dose”) product profile June 25, 2025 -- Bryn Pharma, Inc., (“Bryn”) a privately held pharmaceutical company dedicated to finding novel and

June 25, 2025 -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC) ("Oncotelic" or the "Company"), a clinical-stage biopharmaceutical company focused on RNA-based therapeutics, today announced the publication of a peer-reviewed research article highlighting TGFB2 gene methylation as a positive prognostic biomarker for pancreatic ductal adenocarcinoma (PDAC). The paper, published in collaboration with Sapu Biosciences, LLC (“Sapu”), a wholly owned subsidiary of GMP Biotechnology Limited (“GMP Bio”), in

Amneal holds exclusive U.S. commercialization rights; BLA filing expected in Q4 2025 Poised to be among the first wave of biosimilars in the $3.9 billion U.S. omalizumab market and an important growth driver for Amneal June 25, 2025 -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today highlighted positive topline results from a confirmatory clinical efficacy and safety clinical trial evaluating ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), developed by Kas

June 25, 2025 -- OPKO Health, Inc. (NASDAQ: OPK) and Entera Bio Ltd. (NASDAQ: ENTX) (“Entera”) today announced that new pharmacologic and pharmacokinetic in vivo data for investigational oral OPK-88006 tablet treatment has been selected for presentation at the ENDO 2025 annual meeting of the Endocrine Society, taking place July 12-15, 2025 in San Francisco, CA, USA. Oral OPK-88006 is being developed pursuant to a collaboration and license agreement between OPKO and Entera whereby the companies

Phase 1/2a clinical trial currently supported by a $3.0 million grant from the U.S. Department of Defense Trial will enroll children with high grade glioma and ependymoma June 25, 2025 -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational Ne

June 25, 2025 -- Amicus Therapeutics (Nasdaq: FOLD) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) for the treatment of adult patients with late-onset Pompe disease (LOPD). "We are delighted that we will now be able to offer a compelling new treatment option to patients living with late-onset Pompe disease in Japan. We are grateful to the MHLW and to Japan’s Pompe community, including the patients,

June 25, 2025 — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients worldwide, Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK-headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines, today announced positive topline results from a

Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation Ongoing phase 2 study evaluating riliprubart for the potential prevention and treatment of active antibody-mediated rejection in kidney transplant recipients Riliprubart was also designated orphan drug for the investigational use in chronic inflammatory demyelinating polyneuropathy in the US and EU June 25, 2025. The US Food and Drug Administration (FDA) has granted orphan drug des

- Near doubling of 1-year overall survival (OS), increased median OS of 4 months (12.5 vs 8.5 months), and 43% reduction in risk of death in patients treated with at least one cycle (4 weeks) of elraglusib plus gemcitabine/nab-paclitaxel (GnP) vs GnP alone - Patients with liver metastases experienced a 2.5x improvement in 1-year OS with a 38% reduction in risk of death when treated with elraglusib plus GnP June 24, 2025 -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”)