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Roche's first respiratory test, powered by TAGS technology, has received FDA clearance for SARS-CoV-2, Influenza A, Influenza B, and RSV

Roche announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for the cobas® Respiratory 4-flex. This is the first FDA-cleared assay utilizing Roche's innovative TAGS (Temperature-Activated Generation of Signal) technology, designed...

MediPharm Labs launches a new nighttime inhaler, expanding its leading CBN oil portfolio

MediPharm Labs Corp. a pharmaceutical company specializing in precision-based cannabinoids, is pleased to announce it has launched the new Shake & Puff CBN THC Nighttime Inhaler in Canada. This innovative product expands MediPharm’s leading CBN...

Haleon’s Otrivin® Brand Now Features Aptar’s First Nasal Pump Made with 52% Bio-based Material

Aptar Pharma, a global leader in drug delivery and active material science solutions and services, is proud to announce that its Freepod® nasal spray pump - one of the delivery systems for Haleon's Otrivin® brand - is now made with mass balance...

Made Scientific and Sentinel BioTherapeutics Announce a Strategic Manufacturing Partnership to Advance the Phase I/II Allogeneic ePP Encapsulated Cell Therapy Program

Made Scientific, a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO), and Sentinel BioTherapeutics, a clinical-stage biotechnology company advancing encapsulated cell-based immunotherapies for solid tumors,...

Hengrui’s Heng Qin® (Perfluorohexyloctane Eye Drops) Approved as the First Treatment for Dry Eye Disease Associated with MGD—A Breakthrough in Ophthalmology

Jiangsu Hengrui Pharmaceuticals Co., Ltd. a global pharmaceutical company focused on scientific and technological innovation, and Novaliq GmbH (“Novaliq”), a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based...

Phase 1/2 Clinical Study of Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate AVZO-1418/DB-1418 Begins with First Patient Dosed

Duality Biotherapeutics' partner Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, announced the first patient has been dosed in the Phase 1 portion of a Phase 1/2 clinical...

Innovent Announces Approval from China's NMPA for Mazdutide, the First Dual GCG/GLP-1 Receptor Agonist, for Chronic Weight Management

Innovent Biologics, Inc. a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major...

Alafair Biosciences Announces Enrollment of First Patient in Multi-Center Study Testing VersaWrap® Tendon Protector for Achilles Repair

Alafair Biosciences, Inc., a leading innovator in medical device technology, is pleased to announce the first patient enrolled at UC Davis Foot and Ankle Orthopaedics Clinic, as part of a prospective, multi-center, controlled case series...

enGene’s Detalimogene Receives RMAT Designation from the FDA, Opening the Path for Expedited Review in High-Risk, Non-Muscle Invasive Bladder Cancer

enGene Holdings Inc. a clinical-stage, non-viral gene-based immunotherapy company, announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene voraplasmid (also...

Boehringer Ingelheim and the Lung Cancer Research Foundation Announce New Research Collaboration

The Lung Cancer Research Foundation (LCRF) announces a new research collaboration with Boehringer Ingelheim creating two funding mechanisms designed to address HER2 mutations in lung cancer: a new Team Science Award and an Early Career...

Nuvation Bio’s IBTROZI™ (taletrectinib), a next-generation oral treatment for advanced ROS1-positive non-small cell lung cancer, has been approved by the U.S. Food and Drug Administration

Nuvation Bio Inc. a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced that the U.S. Food and Drug Administration (FDA) has approved IBTROZI™ (taletrectinib) for the treatment of adult...

Avanzanite forms a Pan-European partnership with Agios to introduce PYRUKYND® for rare blood disorders

Avanzanite Bioscience B.V. (“Avanzanite”), a fast-growing commercial-stage specialty pharmaceutical company dedicated to bringing rare disease medicines to patients across Europe, announced an exclusive agreement with Agios Pharmaceuticals Inc. A...

Lubrizol reveals a significant milestone for its innovative, patented Apisolex™ polymer excipient

Lubrizol announces that an Apisolex™ polymer excipient-enabled drug formulation is in Phase 1 clinical trials. Introduced to the market in 2022, Apisolex polymer excipient is a polyamino acid-based polymer that enhances the solubility of BCS Class...

A New Production Line Dedicated to Sterile Hyaluronic Acid Has Been Inaugurated by HTL Biotechnology

On the occasion of National Bioproduction and Biomedicines Day (JNBB), which enjoys the high patronage of the President of the French Republic, HTL Biotechnology confirms its position as a globalleader in the development and production of...

Dr. Behzad Mahdavi Has Been Appointed Executive Chairman of Biodextris to Lead Its Global Commercial Expansion

Biodextris, a leading Contract Development and Manufacturing Organization (CDMO) rooted in the legacy of GSK's biologics and vaccine operations and backed by the healthcare-focused private equity firm ArchiMed, is proud to announce the appointment...

Samsung Bioepis and Organon’s HADLIMA™ Gains FDA Interchangeability Designation, Expanding Access to Adalimumab Alternative

Samsung Bioepis Co., Ltd. and Organon & Co. announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration...

Otulfi® (ustekinumab-aauz) by Fresenius Kabi Now FDA-Approved as an Interchangeable Biosimilar

Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced that the U.S. Food and Drug Administration (FDA) designated Otulfi® (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara® (ustekinumab)....

Research from Noster finds that a gut bacteria-derived molecule can shrink fat cells and improve metabolism

Joint study by University of Shizuoka, Kobe University, and Noster Inc. uncovers a novel postbiotic pathway for obesity prevention.A new collaborative study from the University of Shizuoka, Kobe University, and Kyoto-based biotech company Noster...

Kimera® Labs named a semifinalist in the $101 million XPRIZE Healthspan competition for pioneering innovations in healthy aging

Kimera Labs, Inc., the pioneer in therapeutic exosome biotechnology, is proud to announce its selection as a semifinalist in the prestigious $101 million XPRIZE Healthspan competition. This milestone recognizes Kimera's groundbreaking work in...

Rein Therapeutics announces the initiation of the RENEW Phase 2 trial of LTI-03 in patients with IPF

Rein Therapeutics a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, announced that the RENEW Phase 2 trial of its lead asset,...