Theratechnologies Receives Complete Response Letter (CRL) from the FDA for the F8 Formulation of Tesamorelin sBLA
24 janv. 2024 07h00 HE
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Theratechnologies
FDA requesting clarifications around chemistry, manufacturing and controls and additional information related to immunogenicityCRL does not impact commercial availability of EGRIFTA SV®, the F4...
Theratechnologies reçoit une mise à jour de la FDA concernant son supplément à la licence de produit biologique pour la formulation F8 de la tésamoréline
23 janv. 2024 07h30 HE
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Theratechnologies
La FDA continue d'examiner le dossier après la date butoir du Prescription Drug User Fee Act fixée au 22 janvier 2024 MONTRÉAL, 23 janv. 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc....
Theratechnologies Receives Update from FDA on Tesamorelin F8 Supplemental Biologic License Application
23 janv. 2024 07h30 HE
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Theratechnologies
FDA continues to review the file past the Prescription Drug User Fee Act goal date of January 22, 2024 MONTREAL, Jan. 23, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the...
60 Degrees Pharma Plans Pivotal Babesiosis Study with Tafenoquine Following Jan 17 FDA Meeting
22 janv. 2024 07h59 HE
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Sixty Degrees Pharmaceuticals
Post-FDA meeting, 60 Degrees Pharma plans pivotal study of tafenoquine in hospitalized babesiosis patients, aiming to start in summer 2024. #biotech #SXTP
FDA grants global Medical Device company Biomimetic Innovations ‘Breakthrough Device’ designation for OsStic® Synthetic Injectable Structural Bio-Adhesive Bone Void Filler
19 janv. 2024 10h15 HE
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Biomimetic Innovations Ltd
FDA grants global Medical Device company Biomimetic Innovations ‘Breakthrough Device’ designation for OsStic® Synthetic Injectable Structural Bio-Adhesive.
Optimi Health Secures Amendment to Increase Quantities Of MDMA, MDA, And 2C-B Under Controlled Drugs And Substances Dealer’s Licence
19 janv. 2024 07h30 HE
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Optimi Health Corp.
Optimi Health granted amendment to its Health Canada Controlled Drugs and Substances Licence.
Pleco Therapeutics receives FDA Orphan Drug Designation
16 janv. 2024 11h30 HE
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Pleco Therapeutics B.V.
The U.S Food and Drug Administration (FDA) has granted Orphan Drug Designation to Pleco Therapeutics BV’s lead compound, PTX-252 for the treatment of AML.
Clearmind Medicine Completed Type A Meeting with the FDA
10 janv. 2024 07h18 HE
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Clearmind Medicine Inc.
Tel Aviv, Israel / Vancouver, Canada, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq, CSE: CMND), (FSE: CWY) (“Clearmind” or the "company"), a biotech company focused on...
SOHM Files Provisional Patent on ABBIE’s ‘Smart Gene-Editing’ That Uses Latest Enzymes and Guide RNA to Resolve Off-Target Gene-Editing Limitations
09 janv. 2024 09h30 HE
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SOHM, Inc.
CHINO HILLS, Calif., Jan. 09, 2024 (GLOBE NEWSWIRE) -- via IBN -- SOHM, Inc. (OTC PINK: SHMN) (the “Company”), a pharmaceutical, nutraceutical, cosmeceutical and biotech Company that manufactures...
AAMI and FDA Co-Sponsor Medtech Conference, ‘AAMI and FDA neXus'
08 janv. 2024 09h37 HE
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AAMI
Arlington, VA, Jan. 08, 2024 (GLOBE NEWSWIRE) -- The Association for the Advancement of Medical Instrumentation (AAMI) is delighted to welcome the U.S. Food and Drug Administration as an official...