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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,...

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...

Medtronic, Heart-Valve-Surgery.Com launch 'Aortic Stenosis Patient Activation Platform

Heart-Valve-Surgery.com, a leading patient advocacy group for heart valve disease, with support from Medtronic, a global leader in healthcare technology, today launched the "Aortic Stenosis Patient Activation Platform", an end-to-end digital...

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...

ImmunityBio Announces FDA Approval of ANKTIVA®,

ImmunityBio, Inc. an immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has approved ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of patients with...

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...

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...

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)....

BioTRUST Nutrition® Launches Eternal Mind® Featuring Nutricog®

PLT Health Solutions, Inc. announced BioTRUST Nutrition® LLC, a leading eCommerce-based nutrition brand with a portfolio of high-quality, science-backed products focused on healthy aging and improving healthspan, has introduced a new product...

SK bioscience Receives WHO Prequalification for Typhoid Conjugate Vaccine

SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced that the company has obtained prequalification (PQ) certification from the World Health Organization (WHO). For...

Trailblazing 3D human liver models yield accurate MASH phenotype

Viscient Biosciences ("Viscient") announced that its scientists, along with collaborators from University of California, San Diego, Sanford-Burnham-Prebys medical research institute, and Salk Institute, have published the first demonstration of a...

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