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RSS FeedPosted by Michael Wonder on 21 Feb 2022
Allarity Therapeutics receives refusal to file letters from U.S. FDA
18 February 2022 - Allarity intends to seek guidance from the FDA on how to further advance dovitinib and its ...
Posted by Michael Wonder on 19 Feb 2022
FDA eyes second COVID-19 booster shot
19 February 2022 - The agency has begun reviewing data that could lead to clearing a second booster dose of ...
Posted by Michael Wonder on 19 Feb 2022
FDA’s Califf shares priority list with agency staff
18 February 2022 - Combatting misinformation about science and responding to the ongoing COVID-19 pandemic are the top priorities for ...
Posted by Michael Wonder on 19 Feb 2022
How digital therapeutics platforms are revolutionising health care delivery
17 February 2022 - With enormous advances in digital health innovation, we are quickly moving into an age where software platforms ...
Posted by Michael Wonder on 18 Feb 2022
OSE Immunotherapeutics is pleased to announce that Veloxis Pharmaceuticals, its partner in transplantation, has obtained FDA fast track designation for CD28 antagonist VEL-101/FR104
17 February 2022 - OSE Immunotherapeutics today announced that Veloxis Pharmaceuticals has obtained fast track designation from the U.S. FDA for ...
Posted by Michael Wonder on 18 Feb 2022
Immune-Onc Therapeutics receives FDA fast track designation for IO-202, the first anti-LILRB4 myeloid checkpoint inhibitor, for the treatment of relapsed or refractory acute myeloid leukaemia
17 February 2022 - Immune-Onc Therapeutics today announced that the U.S. FDA has granted fast track designation for IO-202, a first ...
Posted by Michael Wonder on 18 Feb 2022
Agios announces FDA approval of Pyrukynd (mitapivat) as first disease-modifying therapy for haemolytic anaemia in adults with pyruvate kinase deficiency
17 February 2022 - Company to provide robust patient access programs, including $0 copays and free medication for eligible patients. ...
Posted by Michael Wonder on 18 Feb 2022
Dizal Pharmaceutical receives U.S. FDA fast track designation for DZD4205 (golidocitinib) for the treatment of refractory or relapsed peripheral T-cell lymphoma
18 February 2022 - Fast track designation proves Dizal's world leading capability of developing potential first-in-class and much needed therapy to ...
Posted by Michael Wonder on 17 Feb 2022
Dr. Robert Califf returns as FDA's Commissioner
17 February 2022 - The Stakeholder Engagement Staff is pleased to announce the swearing in of Dr. Robert Califf this afternoon, ...
Posted by Michael Wonder on 17 Feb 2022
Agios wins FDA approval for pill to treat rare blood disease
17 February 2022 - The Cambridge company’s CEO says it has the potential to become a blockbuster drug. ...
Posted by Michael Wonder on 17 Feb 2022
Lupin announces FDA approval of supplemental new drug application for Solosec (secnidazole) in adolescents for both the treatment of bacterial vaginosis in females and trichomoniasis
17 February 2022 - Lupin Pharmaceuticals today announced that the U.S. FDA has approved the company's supplemental new drug application to ...
Posted by Michael Wonder on 17 Feb 2022
U.S. FDA accepts for priority review Bristol Myers Squibb’s supplemental biologics license application for Breyanzi (lisocabtagene maraleucel) as a second-line therapy for relapsed or refractory large B-cell lymphoma
17 February 2022 - U.S. FDA has assigned a target action date of 24 June 2022. ...
Posted by Michael Wonder on 17 Feb 2022
FDA grants fast track designation to SBT101, the first investigational AAV based gene therapy for patients with adrenomyeloneuropathy
16 February 2022 - Initiation of Phase 1/2 clinical trial expected in the second half of 2022. ...
Posted by Michael Wonder on 16 Feb 2022
Acadia Pharmaceuticals announces resubmission of supplemental new drug application to U.S. FDA for Nuplazid (pimavanserin) to treat Alzheimer’s disease psychosis
16 February 2022 - Acadia Pharmaceuticals announced today that it has resubmitted its supplemental new drug application for pimavanserin for ...
Posted by Michael Wonder on 16 Feb 2022
Bonalive Biomaterials granted FDA breakthrough device designation for a bone graft substitute that potentially protects against microbial colonisation
16 February 2022 - The Center for Devices and Radiological Health at the U.S. FDA has determined that Bonalive Orthopedics granules, ...