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Octapharma USA: FDA Grants Orphan Drug Exclusivity to wilate®

Octapharma USA, Inc. announced the U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for wilate®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection,...

Aurora enhances Australian offerings with premium dried flower range

Aurora Cannabis Inc. the Canadian based leading global medical cannabis company, in conjunction with MedReleaf Australia, is pleased to announce the expansion of its portfolio with the introduction of a new range of premium dried cannabis flower...

TIVDAK® Receives U.S. FDA Approval to Treat Recurrent or Metastatic Cervical Cancer

Genmab A/S announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TIVDAK® (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer...

Cold Box Express, Inc. Introduces Refreshed Brand

Cold Box Express, Inc. (CBX) has announced a rebranding of both the company and its product the ClimateCrate™ (formerly COLD BOX). While the corporate company name remains Cold Box Express, Inc., the evolution to CBX simplifies the logo and helps...

Avenacy announces launch of Eptifibatide for Injection in the U.S.

Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Eptifibatide for Injection in the United States as a therapeutic equivalent generic for Integrilin® for Injection...

Onconic Therapeutics gets MFDS nod for JAQBO, a fresh remedy for Gastroesophageal Reflux Disease

Onconic Therapeutics, a leading biotechnology company in Korea, announced that the Ministry of Food and Drug Safety (MFDS) of Korea has approved JAQBO (zastaprazan citrate) for the treatment of erosive gastroesophageal reflux disease (GERD) in...

Nature Publication Highlights the Benefits of Tropis® Intradermal

PharmaJet®, a company that strives to improve the performance and outcomes of medicines with its innovative delivery systems, announced the Nature publication1 of Gennova Biopharmaceutical’s Phase 2/3 clinical trial conducted to evaluate the...

Renibus Therapeutics to Present RBT-1 at European Association for Cardio-Thoracic Surgery

Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio, renal and metabolic diseases, announced an oral presentation on RBT-1 at the prestigious, RBT-1 (stannic protoporfin...

Moleculin's AML treatment gets EMA's Orphan Drug Designation

Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, announced that the European Medicines Agency has...

Algiax Pharmaceuticals expands AP-325 study in chronic neuropathic pain, adds 12 sites in Belgium and France

Algiax Pharmaceuticals, today provided an update on its ongoing Phase 2a study (NCT04429919) with lead candidate AP-325 in patients with chronic neuropathic pain. Based on last year's positive mid-enrollment interim analysis and confirmed...

Pyros Pharma announces VIGPODER™ (vigabatrin)

Pyros Pharmaceuticals, Inc. (Pyros or the Company), a leader in the development of enhanced specialty pharmaceuticals for rare diseases, announced that VIGPODER™ (vigabatrin) for oral solution, USP, a treatment for appropriate patients with...

UPSHER-SMITH LAUNCHES METHIMAZOLE TABLETS, USP

Upsher-Smith Laboratories, LLC (Upsher-Smith) announced the recent launch of Methimazole Tablets, USP, 5 mg and 10 mg. The Methimazole Tablet market had U.S. sales of approximately $36.8 million for the 12 months ending December 2023 according to...

Neurocrine Biosciences begins Phase 1 trial on NBI-1065890, a second-gen VMAT2 inhibitor, in healthy adults

Neurocrine Biosciences, Inc. announced the initiation of its Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1065890 in healthy adult participants. NBI-1065890 is...

Brainomix's AI-Powered e-Lung, Developed with AstraZeneca, Improves Identification of Lung Fibrosis Patients at Risk

Brainomix, the AI-powered medtech company, announces the publication of a new study in the prestigious peer-reviewed journal American Journal of Respiratory and Critical Care Medicine (AJRCCM)1, resulting from a research collaboration AstraZeneca,...

Akebia's Vafseo® (vadadustat) Tablets FDA Approved for Anemia Treatment in Dialysis Patients

Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo® (vadadustat)....

Psilera Welcomes Biopharma Executive Dr. Magali Haas to its Board of Directors

Psilera, a leading biotechnology company developing groundbreaking therapies for hard-to-treat neurological disorders, is pleased to announce the appointment of Magali Haas, M.D., Ph.D., to its esteemed Board of Directors. Dr. Haas brings a wealth...

Telix's TLX250-CDx: First Patient Dosed in Italian Early Access Program for Kidney Cancer Imaging

Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the first patient has been dosed in its named patient program in Italy for TLX250-CDx (89Zr-DFO-girentuximab, Zircaix™. TLX250-CDx is the Company's investigational...

Gedeon Richter Chooses Trial Interactive for Streamlined Clinical Trial Management

TransPerfect Life Sciences, a leading global provider of solutions for product development and launch for the biopharmaceutical industry, today announced that Gedeon Richter selected Trial Interactive's award-winning eTMF platform and TI...

Aptamer Sciences Inc.Innovative Liver Cancer Treatment AST-201

Aptamer Sciences Inc. (KOSDAQ, 291650) announced the filing of an Investigational New Drug (IND) application for the phase 1 clinical trial of AST-201. AST-201, the company's pioneering candidate in its pipeline, is an ApDCTM (Aptamer-Drug...

Translational Vision Science and Technology Journal Publishes RadiusXR's NOVA Clinical Trial

RadiusXR, the trailblazer in Digital Health, announces the publication of its groundbreaking NOVA Clinical Trial in Translational Vision Science and Technology (TVST), a prestigious journal by the Association for Research in Vision and...