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RSS FeedPosted by Michael Wonder on 18 Jan 2024
Verastem Oncology granted fast track designation for combination of avutometinib and sotorasib for the treatment of KRAS G12C mutant non-small-cell lung cancer
18 January 2024 - On-going RAMP 203 trial assessing a more complete vertical blockade with RAF/MEK and KRAS G12C inhibition along ...
Posted by Michael Wonder on 18 Jan 2024
UtilityTherapeutics announces FDA acceptance of PIVYA new drug application with priority review
17 January 2024 - Utility has received a Prescription Drug User Fee Act target action date of 24 April 2024. ...
Posted by Michael Wonder on 18 Jan 2024
US FDA declines to approve Shin Nippon Biomedical's migraine drug
17 January 2024 - The US health regulator has declined to approve Japan-based Shin Nippon Biomedical Laboratories' treatment for acute ...
Posted by Michael Wonder on 17 Jan 2024
Dupixent (dupilumab) US label updated with data further supporting use in atopic dermatitis with moderate to severe hand and foot involvement
16 January 2024 - Data included from first and only Phase 3 trial specifically evaluating a biologic in this difficult to ...
Posted by Michael Wonder on 17 Jan 2024
Atsena Therapeutics receives rare paediatric disease designation from FDA for ATSN-101 gene therapy for GUCY2D associated Leber congenital amaurosis
16 January 2023 - Atsena Therapeutics today announced the US FDA has granted rare paediatric disease designation to ATSN-101, the company’s ...
Posted by Michael Wonder on 16 Jan 2024
Nurix Therapeutics receives US FDA fast track designation for NX-5948 for the treatment of relapsed or refractory CLL and SLL
16 January 2024 - Fast track designation follows positive Phase 1 data presented at the American Society of Hematology that supports ...
Posted by Michael Wonder on 16 Jan 2024
NRx Pharmaceuticals announces FDA qualified infectious disease product and fast track designation of NRX-101 in complicated urinary tract infection and pyelonephritis
16 January 2024 - QIDP designation grants priority review and an additional 5 years of additional product exclusivity. ...
Posted by Michael Wonder on 16 Jan 2024
US FDA approves Takeda’s HyQvia as maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy
16 January 2024 - Approval based on Phase 3 ADVANCE-CIDP 1 study demonstrating a statistically significant difference in relapse rate in ...
Posted by Michael Wonder on 16 Jan 2024
Vertex announces US FDA approval of Casgevy (exagamglogene autotemcel) for the treatment of transfusion-dependent beta thalassaemia
16 January 2024 - Approximately 1,000 patients in the US 12 years of age and older are now eligible for ...
Posted by Michael Wonder on 14 Jan 2024
Drug Farm receives rare paediatric disease designation from the US FDA for DF-003 to treat ROSAH syndrome
13 January 2024 - Drug Farm announced that the US FDA has granted rare paediatric disease designation for the company’s ...
Posted by Michael Wonder on 14 Jan 2024
RemeGen's RC88 obtained FDA fast track designation, heralds new hope for ovarian cancer patients
12 January 2024 - RemeGen announced recently that its independently developed mesothelin targeting antibody drug conjugate RC88 has been granted fast ...
Posted by Michael Wonder on 14 Jan 2024
Shorla Oncology announces FDA filing acceptance of new drug application for novel formulation to treat breast and ovarian cancer
9 January 2024 - Shorla Oncology announced today that the US FDA has accepted for review the company’s new drug application ...
Posted by Michael Wonder on 14 Jan 2024
FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 stage III-IVA cervical cancer
15 January 2024 - On 12 January 2024, the FDA approved pembrolizumab (Keytruda) with chemoradiotherapy for patients with FIGO 2014 stage ...
Posted by Michael Wonder on 10 Jan 2024
AARP statement on FDA’s prescription drugs importation approval for Florida
8 January 2024 - AARP Executive Vice President and Chief Advocacy and Engagement Officer Nancy LeaMond issued the following statement ...
Posted by Michael Wonder on 10 Jan 2024
Tivdak supplemental biologics license application accepted for priority review by FDA for patients with recurrent or metastatic cervical cancer
9 January 2024 - Submission based on positive results from global Phase 3 study demonstrating overall survival benefit of TIVDAK ...