Regulatory News

Found 23,557 articles

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  FDA Action Alert: Sarepta, Protalix, Otsuka/Lundbeck and More

  5/8/2023

  The FDA's agenda includes an advisory committee meeting for Sarepta's delandistrogene moxeparvovec, which, if approved, would become the first gene therapy for Duchenne muscular dystrophy.
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  FDA Guidance May Bolster Confidence in Decentralized Clinical Trials

  5/8/2023

  The FDA’s new guidance on decentralized clinical trials clarifies how investigators and trial sponsors can use digital health technologies and involve primary healthcare practitioners.

• Immuron Announces FDA Removed Clinical Hold on New Campylobacter ETEC Therapeutic Paves way for Clinical Trial Initiation

  5/8/2023

  Immuron Limited is pleased to announce that the US Naval Medical Research Center has received approval from the US Food and Drug Administration to proceed with the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli developed in collaboration with Immuron.

• HAPPE Spine Announces FDA Clearance for the INTEGRATE-C™ Interbody Fusion System

  5/8/2023

  HAPPE Spine announces that the company's INTEGRATE-C™ Interbody Fusion System has received 510k clearance from the FDA.

• PharmaDrug Announces Cease Trade Order

  5/8/2023

  PharmaDrug Inc. (CSE: PHRX) (OTCQB: LMLLF) ("PharmaDrug" or the "Company"), is announcing that the Ontario Securities Commission has issued a "failure to file" cease trade order in respect of the Company's securities under Multilateral Instrument 11-103 Failure-to- File Cease Trade Orders in Multiple Jurisdictions (the "CTO").

• New Therapy for Rare Gastrointestinal Stromal Tumours Approved in Singapore

  5/7/2023

  Independent biopharmaceutical company Specialised Therapeutics Asia is pleased to announce that a new therapy to treat rare gastrointestinal stromal tumours shown to improve survival has been approved for use in Singapore.

• Suzhou GenAssist Therapeutic Co.,Ltd recently announced that its first base editing product, GEN6050, has submitted a pre-IND application to the FDA and has been accepted

  5/6/2023

  Suzhou GenAssist Therapeutic Co.,Ltd recently announced its pre-IND application of their first base editing product, GEN6050 and the acceptance by the FDA.

• Zoetis Announces U.S. FDA Approval of Librela™ (bedinvetmab injection) to Control Osteoarthritis (OA) Pain in Dogs

  5/5/2023

  Zoetis Inc. announced that the U.S. Food and Drug Administration has approved Librela™ for the control of pain associated with osteoarthritis in dogs.

• Nexus Pharmaceuticals, Inc. Receives Successful FDA Inspection of Pharmaceutical Manufacturing Facility in Pleasant Prairie, Wisconsin

  5/5/2023

  Nexus Pharmaceuticals, Inc. announced that its pharmaceutical manufacturing facility in Pleasant Prairie, Wisconsin, was successfully inspected by the Food and Drug Administration, which will allow Nexus to begin commercial operations.

• FDA Roundup: May 05, 2023

  5/5/2023

  The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

• Formosa Pharmaceuticals and AimMax Therapeutics Announce the NDA Submission to the US FDA for APP13007 for the Treatment of Post-Operative Inflammation and Pain following Ocular Surgery

  5/5/2023

  Formosa Pharmaceuticals, Inc. and AimMax Therapeutics, Inc. announce the submission of a New Drug Application to the United States Food & Drug Administration for APP13007, a novel aqueous nanosuspension formulation of the potent corticosteroid, clobetasol propionate, for the treatment of inflammation and pain following ocular surgery.

• Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce European Commission Authorization of PRX-102 (pegunigalsidase alfa) for the Treatment of Fabry Disease

  5/5/2023

  Chiesi Global Rare Diseases and Protalix BioTherapeutics, Inc. announced that the European Commission has granted marketing authorization to PRX-102 in the European Union for the treatment of adult patients with Fabry disease.

• Norlase Receives FDA 510(k) Clearance and CE Mark Approval For ECHO™ Green Pattern Laser

  5/5/2023

  Norlase, a leading global ophthalmic laser manufacturer developing next-generation laser solutions, announced it has received both FDA 510 clearance and CE Mark approval for the ECHO Green Pattern Laser photocoagulator.

• Vyant Bio Announces Filing of Form 25 for Voluntary Nasdaq Delisting and SEC Deregistration

  5/4/2023

  Vyant Bio, Inc. is a biotechnology company that incorporates innovative biology and data science to improve drug discovery for complex neurodevelopmental and neurodegenerative disorders.

• Nucleix’s Bladder EpiCheck® Receives FDA 510(k) Clearance for Monitoring of Non-Muscle Invasive Bladder Cancer (NMIBC) Recurrence

  5/4/2023

  Nucleix has received 510 clearance from the U.S. Food and Drug Administration to market Bladder EpiCheck® for use as a non-invasive method for surveillance of tumor recurrence in patients previously diagnosed with non-muscle invasive bladder cancer, in conjunction with cystoscopy.

• Avertix, Maker of First and Only FDA-Approved Implantable Heart Attack Warning System, to Become Publicly Traded via Merger with BIOS Acquisition Corporation

  5/3/2023

  Avertix Medical, Inc. and BIOS Acquisition Corporation announced that the companies have entered into a definitive merger agreement for a business combination that would result in Avertix becoming a publicly traded company on Nasdaq.

• USPTO Agrees to Kurin’s Request to Review Validity of Magnolia Medical’s ‘483 Patent

  5/3/2023

  Kurin, Inc. announced that the US Patent and Trademark Office has granted Kurin’s Ex Parte request to reexamine the validity of U.S. Patent No. 10,039,483 that is asserted by Magnolia Medical in ongoing patent litigation.

• Adagio Medical Announces Completion of Enrollment in Cryocure-VT Trial, Maps the Pathway to CE-Mark of vCLAS™ VT Ablation Catheter

  5/3/2023

  Adagio Medical, Inc., a leading innovator in catheter ablation technologies for atrial fibrillation and ventricular tachycardia, announced the completion of enrollment in its Cryocure-VT trial of ultra-low temperature cryoablation for the treatment of monomorphic ventricular tachycardias.

• FDA Roundup: May 02, 2023

  5/2/2023

  The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

• Memo Therapeutics AG Receives FDA Fast Track Designation for AntiBKV as Treatment of BKV Infection in Renal Transplant Patients

  5/2/2023

  Memo Therapeutics AG announced that the U.S. Food and Drug Administration has granted Fast Track designation to AntiBKV, MTx’s lead antibody therapeutic that targets BK polyomavirus infection commonly seen in renal transplant patients.