Recent blog posts
AbbVie's IL-23 antibody Risankizumab completes regulatory filing for new indications in Europe and the United States
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AbbVie's IL-23 antibody Risankizumab completes regulatory filing for new indications in Europe and the United States
31 August 2023
On August 29, 2023, AbbVie submitted a new indication application to the US FDA and European EMA for Skyrizi (Risankizumab) for the treatment of moderate to severe ulcerative colitis (UC) in adults.
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The European Commission Approves KEYTRUDA® (pembrolizumab) plus Trastuzumab and Chemotherapy, as a treatment for HER2-Positive Advanced Gastric or Gastroesophageal Junction
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The European Commission Approves KEYTRUDA® (pembrolizumab) plus Trastuzumab and Chemotherapy, as a treatment for HER2-Positive Advanced Gastric or Gastroesophageal Junction
31 August 2023
Merck announced that Merck announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score≥1).
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AEON Biopharma Discloses Encouraging Outcomes of ABP-450 Phase 2 Clinical Study in Cervical Dystonia
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AEON Biopharma Discloses Encouraging Outcomes of ABP-450 Phase 2 Clinical Study in Cervical Dystonia
31 August 2023
AEON Biopharma, Inc. has shared encouraging results from their recent Phase 2 medical trial of ABP-450.
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TScan Therapeutics announces their IND application for TSC-203-A0201 received clearance from the FDA
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TScan Therapeutics announces their IND application for TSC-203-A0201 received clearance from the FDA
31 August 2023
TScan Therapeutics, Inc.announced today that the U.S. FDA has given approval for its new experimental drug TSC-203-A0201, a TCR-T pinpointing PReferentially expressed Antigen in Melanoma.
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SparingVision announces encouraging safety Data in its phase I/II PRODYGY Gene Therapy Trial of SPVN06
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SparingVision announces encouraging safety Data in its phase I/II PRODYGY Gene Therapy Trial of SPVN06
31 August 2023
SparingVision has shared encouraging early safety data from the Phase I/II clinical trial of its primary gene-agnostic gene therapy, SPVN06, designed to treat retinitis pigmentosa.
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Janssen Seeks Expanded Approval for Rybrevant In combination with Chemotherapy
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Janssen Seeks Expanded Approval for Rybrevant In combination with Chemotherapy
30 August 2023
Janssen has filed an additional Biologics License Application with the U.S. Food and Drug Administration, seeking endorsement for RYBREVANT® (amivantamab-vmjw) to be combined with Chemotherapy.
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FDA Conditionally Approves Tourmaline Bio's TOUR006 IND Application
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FDA Conditionally Approves Tourmaline Bio's TOUR006 IND Application
30 August 2023
Tourmaline Bio reported that the FDA has conditionally approved the Investigational New Drug (IND) application for TOUR006.
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Atsena Therapeutics' ATSN-201 Phase I/II clinical trial has completed the first patient dosing
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Atsena Therapeutics' ATSN-201 Phase I/II clinical trial has completed the first patient dosing
30 August 2023
The inaugural patient has been administered with ATSN-201 under the Phase I/II Clinical Trial, for combatting X-linked Retinoschisis, as announced by Atsena Therapeutics.
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U.S. FDA Approves BMS Reblozyl® as First-Line Treatment of Anemia in Adults with Lower-Risk MDS
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U.S. FDA Approves BMS Reblozyl® as First-Line Treatment of Anemia in Adults with Lower-Risk MDS
30 August 2023
The U.S. FDA has sanctioned the use of Bristol Myers Squibb's Reblozyl® (luspatercept-aamt) as an initial treatment option for anemia in adults suffering from low-risk Myelodysplastic Syndromes (MDS) who might need transfusions.
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Formycon announces File Acceptance for FYB203 by the U.S. FDA
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Formycon announces File Acceptance for FYB203 by the U.S. FDA
30 August 2023
Formycon has publicized that its biosimilar candidate FYB203, a potential replica of Eylea® (aflibercept), has been approved for filing by the U.S. Food and Drug Administration (FDA).
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AbbVie has lodged filings with the FDA and EMA for approval of Risankizumab (SKYRIZI®) to treat Ulcerative Colitis
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5 min read
AbbVie has lodged filings with the FDA and EMA for approval of Risankizumab (SKYRIZI®) to treat Ulcerative Colitis
30 August 2023
This IL-23 inhibitor, risankizumab, is being tested as a potential remedy for adults suffering from moderately to severely active ulcerative colitis.
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The primary objective of BlueRock's Phase I trial involving bemdaneprocel for individuals suffering from Parkinson's disease has been successfully achieved
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The primary objective of BlueRock's Phase I trial involving bemdaneprocel for individuals suffering from Parkinson's disease has been successfully achieved
30 August 2023
The investigational cell treatment, bemdaneprocel (BRT-DA01), showed good tolerance and no major safety concerns throughout a year in 12 subjects belonging to both low and high dose groups.
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