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Lykos Therapeutics Provides Update on FDA Advisory Committee Meeting for Investigational MDMA-Assisted PTSD Therapy

Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, announced the outcome of the U.S. Food and Drug Administration's ("FDA") Psychopharmacologic Drugs Advisory Committee ("PDAC"), which discussed the Company's new...

Orthofix Receives FDA 510(k) Clearance for Rodeo™ Telescopic Nail

Orthofix Medical Inc. a leading global spine and orthopedics company, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Rodeo™ Telescopic Nail. The Rodeo Telescopic Nail is an innovative...

Regulus Therapeutics Progresses to Cohort 4 in Phase 1b MAD Trial of RGLS8429 for ADPKD Treatment

Regulus Therapeutics Inc. a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs today announced, after review of all available safety data, the Company initiated screening of the fourth...

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,...

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...

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...

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...

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...

Tetra Pharm Technologies advances CB1 antagonist, TPT0701, for appetite suppression into preclinical testing

Following the successful filing of Intellectual Property (IP) for their applied platform technology targeting the endocannabinoid system (ECS), Tetra Pharm Technologies, is moving forward with its compound for appetite suppression, TPT0701....

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