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Biogen and Sage Therapeutics Announce FDA Accepts Filing of New Drug Application for Zuranolone
Monday, February 06, 2023Biogen announced the US Food and Drug Administration FDA has accepted the filing of a New Drug Application NDA for zuranolone in the treatment of major depressive disorder MDD and postpartum depression PPD Zuranolone is an investigational drug being...
U.S. FDA Approves Trodelvy® in Pre-treated HR+/HER2- Metastatic Breast Cancer
Saturday, February 04, 2023Gilead Sciences announced the US Food and Drug Administration FDA has approved Trodelvy sacituzumab govitecanhziy for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor HRpositive human epidermal growth...
Revive Therapeutics Enters into Research Collaboration Agreement with PharmaTher
Saturday, February 04, 2023Revive Therapeutics announced that it has entered into a research collaboration agreement with PharmaTher Holdings to evaluate the delivery of Methylenedioxymethamphetamine MDMA using PharmaThers novel microneedle patch MNPatch delivery technology
U.S. FDA Approves Takeda’s TAKHZYRO® (lanadelumab-flyo) to Prevent Hereditary Angioedema (HAE) Attacks
Saturday, February 04, 2023Takeda announced that the US Food and Drug Administration FDA has approved the supplemental Biologics Licence Application sBLA for the expanded use of TAKHZYRO lanadelumabflyo for prophylaxis to prevent attacks of hereditary angioedema HAE in paediat...
4D Molecular Therapeutics Announces FDA Clearance of IND Application for 4D-150 Genetic Medicine
Friday, February 03, 2023D Molecular Therapeutics announced FDA clearance of the Investigational New Drug Application IND for D an R vectorbased intravitreal genetic medicine for the treatment of patients with Diabetic Macular Oedema DME D Phase SPECTRA clinical trial for d...
PharmaTher Holdings Announces FDA Grant of Orphan Drug Designation to KETARX™
Friday, February 03, 2023PharmaTher announced that the US Food and Drug Administration FDA has granted orphan drug designation to KETARX racemic ketamine for the treatment of Rett Syndrome a rare genetic neurological disorder Phase clinical study results to support proposed...
Tonix Pharmaceuticals Announces Acquisition of Preclinical Infectious Disease Portfolio
Friday, February 03, 2023Tonix Pharmaceuticals announced an agreement whereby Tonix will acquired all of the assets of Healion Bio Inc Healion including its entire portfolio of nextgeneration antiviral technology assets The Acquired Portfolio of Infectious Disease Assets inc...
Pliant Therapeutics Announces FDA Clearance of Investigational New Drug Application for PLN-101095
Friday, February 03, 2023Pliant Therapeutics announced that the US Food and Drug Administration FDA has cleared the companys Investigational New Drug IND application for PLN an oral small molecule dual selective inhibitor of integrins v and v A Phase firstinhuman study eval...
US FDA Granted Orphan Drug Designation for Benlysta
Thursday, February 02, 2023GSK announced that the US Food and Drug Administration FDA has granted Orphan Drug Designation ODD to Benlysta belimumab a Bcell inhibiting monoclonal antibody for the potential treatment of systemic sclerosis GSK plans to initiate a phase IIIII tria...
Cybin Announces Approval of First-in-Human Dosing of its Proprietary DMT Molecule CYB004
Thursday, February 02, 2023Cybin announced that it has received approval from an independent ethics committee in the Netherlands to initiate firstinhuman dosing of its proprietary deuterated NNdimethyltryptamine DMT molecule CYB through a protocol amendment to its ongoing CYBE...
