pharma news
May 23, 2023
FDA Approves RINVOQ for Crohn’s Disease; FDA Approves Krystal Biotech’s Gene Therapy Vyjuvek; FDA Approves EPKINLY to Treat R/R DLBCL; FDA Orphan Drug Designation to Mitazalimab; Phase 3 Trial Result of OCS-01 Eye Drops; TAGRISSO® + Chemotherapy for the EGFR-mutated Advanced Lung Cancer
FDA Approves RINVOQ as a Once-Daily Pill for Moderately to Severely Active Crohn's Disease AbbVie announced that the FDA had approved RINVOQ® (upadacitinib) for treating people with moderately to highly active Crohn's disease who have had an unsatisfactory response or intolerance to one or more TNF blockers. Thi...
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May 16, 2023
Sarepta Therapeutics’s SRP-9001 Gene Therapy; FDA Approves Astellas’ VEOZAH; FDA Orphan Drug Designation and Rare Pediatric Disease Designation to SiSaf’s siRNA Therapy SIS-101-ADO; FDA Grants Fast Track Designation to IMPT-314; FDA Approves First Drug for Agitation in People With Alzheimer’s Disease; FDA Accepted the CytoAgents’ IND Application for CTO1681
Sarepta Therapeutics Announces Positive Vote from U.S. FDA Advisory Committee Meeting for SRP-9001 Gene Therapy Sarepta Therapeutics, Inc., a pioneer in precision genetic medicine for rare diseases, announced that the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) voted 8 to 6 in favor of...
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May 09, 2023
FDA Approves GSK’s Arexvy for RSV; CHMP’s Opinion on Gilead’s Hepcludex® for HDV; FDA Clearance to ProMIS’s IND Application for PMN310; FDA Grants 501K Clearance to Bladder EpiCheck; PharmaTher Submits Fast Track Application for Ketarx to US FDA; Fast Track Designation to Vedanta Biosciences’ VE303
FDA Approves GSK’s Arexvy, the First RSV Vaccine for Older Adults GSK plc stated that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by a respiratory syncytial virus (RSV) in peopl...
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May 02, 2023
FDA Grants Priority Review to BMS’ Luspatercept; Teva and MedinCell’s Risperidone FDA Approval; Biogens’s QALSODY FDA Accelerated Approval; FDA IND Authorization to Kiromic’s Deltacel; Atsena’s ATSN-201 FDA IND Clearance
FDA Grants Priority Review to Luspatercept for First-line Treatment of Anemia in Lower-risk MDS The FDA has granted priority review to a supplemental biologics license application (sBLA) seeking to expand the current indication of luspatercept-aamt (Reblozyl) to include treatment of anemia in patients with very ...
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Apr 25, 2023
Janssen’s AKEEGA Approval; FDA Approves Roche’s Polivy Combo for Frontline B-cell Lymphoma; Daiichi Sankyo’s Quizartinib for Adults With FLT3-ITD-Positive AML; bluebird bio BLA for lovo-cel for Patients with Sickle Cell Disease; Fast Track Designation for Lu-PNT2002 for mCRPC Treatment; FDA Orphan Drug Designation to XORTX’s Oxypurinol
Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) had granted marketing authorization for AKEEGA® (niraparib and abiraterone acetate [AA]), in the form...
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Apr 18, 2023
RegeneRx’s Phase 3 Neurotrophic Keratitis Clinical Trial of RGN-259; Aldeyra’s Phase 3 INVIGORATE-2 Clinical Trial Update; FDA Orphan Drug Designation to Oncolyze’s OM-301 for Multiple Myeloma; Soligenix Provides Regulatory Update on HyBryte; FDA Fast Track Designation to SAB Biotherapeutics’s SAB-176 Influenza Immunotherapy; Aviceda IND Application for AVD-104
RegeneRx Biopharmaceuticals Enrolled First Patient in the Phase 3 Neurotrophic Keratitis Clinical Trial with RGN-259 in the US On April 12, 2023, RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx" or "Company") announced that the first patient of Phase 3 clinical trial (SEER-2) of RGN-259, a novel treat...
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Apr 11, 2023
Ipsen’s Cabometyx Rejected by NICE; Vertex and CRISPR Therapeutics’s Submit BLA to the FDA for exa-cel; Orphan Drug Designation to Osemitamab for Pancreatic Cancer; FDA Clears Keytruda/Padcev for Bladder and Urothelial Cancer; Cingulate Completes Trial of CTx-1301 for ADHD; Nuance Pharma Announces Dosing of First Patient in ENHANCE Trial
FDA Grants Orphan Drug Designation to Osemitamab for Pancreatic Cancer Transcenta Holding Limited has announced that the U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designation to Osemitamab (TST001), a highly potent humanized monoclonal antibody that enhances ADCC (antibody-dependent cell-me...
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Mar 28, 2023
Novartis Announces the Positive Results of Phase III NATALEE Trial Evaluating Kisqali; FDA Approves Pharming’s Joenja for APDS; FDA Orphan Drug Designation to Cyclerion’s Zagociguat; Iovance Completes BLA Submission for Lifileucel in Advanced Melanoma; BPGbio Announces Partnership with debra of America
Novartis Announces the Positive Results of Phase III NATALEE trial Evaluating Kisqali Novartis announced positive topline results from an interim analysis of NATALEE, a Phase III trial evaluating Kisqali® (ribociclib) plus endocrine therapy (ET) in a broad population of patients with hormone receptor-positive/hu...
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Mar 23, 2023
Viz.ai’s AI Algorithm for Abdominal Aortic Aneurysm; BrainTale Unveils the New Version of Its Digital Biomarkers Platform brainTale-care; Medtronic and NVIDIA Announces Collaboration; Median Technologies Announces Update for its iBiopsy Lung Cancer Screening CADe/CADx Software as Medical Device
Viz.ai is First to Receive FDA 510(k) Clearance for AI Algorithm for Abdominal Aortic Aneurysm On March 21, 2023, Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, announced it had received U.S. Food and Drug Administration (FDA) 510(k) clearance for its algorithm intended to ...
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Mar 21, 2023
AbbVie Announces Results of Study Evaluating SKYRIZI; FDA Fast Track Designation to Arrowhead’s ARO-APOC3; FDA Approves Dabrafenib Plus Trametinib for BRAF V600E–Mutated Low-Grade Glioma; FDA Grants ODD to Novel BRAF Inhibitor for Brain/CNS Malignancies; EP0042 Wins FDA Orphan Drug Status; Karuna Therapeutics Announces Results from Phase 3 EMERGENT-3 Trial of KarXT in Schizophrenia
AbbVie Announces Positive Results of Study Evaluating SKYRIZI in Plaque Psoriasis Patients AbbVie announced new 52-week data from an open-label, a single-arm study demonstrating improved plaque psoriasis signs and symptoms in a difficult-to-treat patient population who received SKYRIZI® (risankizumab), an IL-23 ...
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