Recent blog posts
BridgeBio's TTR stabilizer acoramidis achieves primary endpoint in Phase 3 clinical trial
Latest Hotspot
3 min read
BridgeBio's TTR stabilizer acoramidis achieves primary endpoint in Phase 3 clinical trial
31 August 2023
Recently, BridgeBio Pharma announced that its investigational treatment, acaracides, achieved its primary endpoint in the phase 3 clinical trial.
Read →
Novartis releases positive Phase 3 trial data for its PCSK9-targeted siRNA therapy, inclisiran
Latest Hotspot
4 min read
Novartis releases positive Phase 3 trial data for its PCSK9-targeted siRNA therapy, inclisiran
31 August 2023
On August 29, 2023, Novartis released new long-term data from its ORION-8 Phase 3 clinical trial. The data showed that its twice-yearly RNAi therapy, Leqvio (Inclisiran, Sodium Echociliran), in combination with statins.
Read →
AbbVie's IL-23 antibody Risankizumab completes regulatory filing for new indications in Europe and the United States
Latest Hotspot
3 min read
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.
Read →
The European Commission Approves KEYTRUDA® (pembrolizumab) plus Trastuzumab and Chemotherapy, as a treatment for HER2-Positive Advanced Gastric or Gastroesophageal Junction
Latest Hotspot
4 min read
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).
Read →
AEON Biopharma Discloses Encouraging Outcomes of ABP-450 Phase 2 Clinical Study in Cervical Dystonia
Latest Hotspot
5 min read
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.
Read →
TScan Therapeutics announces their IND application for TSC-203-A0201 received clearance from the FDA
Latest Hotspot
4 min read
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.
Read →
SparingVision announces encouraging safety Data in its phase I/II PRODYGY Gene Therapy Trial of SPVN06
Latest Hotspot
5 min read
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.
Read →
Janssen Seeks Expanded Approval for Rybrevant In combination with Chemotherapy
Latest Hotspot
5 min read
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.
Read →
FDA Conditionally Approves Tourmaline Bio's TOUR006 IND Application
Latest Hotspot
4 min read
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.
Read →
Atsena Therapeutics' ATSN-201 Phase I/II clinical trial has completed the first patient dosing
Latest Hotspot
4 min read
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.
Read →
U.S. FDA Approves BMS Reblozyl® as First-Line Treatment of Anemia in Adults with Lower-Risk MDS
Latest Hotspot
6 min read
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.
Read →
Formycon announces File Acceptance for FYB203 by the U.S. FDA
Latest Hotspot
3 min read
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).
Read →