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RSS FeedPosted by Michael Wonder on 24 May 2022
Blue Lake Biotechnology announces FDA fast track designation for BLB-201 intranasal RSV vaccine
24 May 2022 - Blue Lake Biotechnology today announced that the U.S. FDA has granted fast track designation for BLB-201, an ...
Posted by Michael Wonder on 24 May 2022
United Therapeutics announces FDA approval of Tyvaso DPI
24 May 2022 - First approval of a dry powder inhaler for treatment of pulmonary arterial hypertension and pulmonary hypertension associated with ...
Posted by Michael Wonder on 24 May 2022
FDA grants breakthrough device designation to Anumana’s ECG pulmonary hypertension early detection AI algorithm
24 May 2022 - Anumana today announced that the U.S. FDA has granted breakthrough device designation to its AI-enhanced, ECG based ...
Posted by Michael Wonder on 24 May 2022
FDA accepts CSL Behring's biologics license application for etranacogene dezaparvovec for priority review
24 May 2022 - If approved, etranacogene dezaparvovec would be the first gene therapy option for people living with haemophilia B. ...
Posted by Michael Wonder on 24 May 2022
Neuronascent receives FDA rare paediatric drug designation for NNI-351 treatment for Fragile X syndrome
24 May 2022 - Neuronascent today announced that the US FDA granted rare paediatric designation for NNI-351 for Fragile X ...
Posted by Michael Wonder on 24 May 2022
FDA approves Dermavant’s Vtama (tapinarof) 1% cream for the treatment of plaque psoriasis in adults: first topical novel chemical entity launched for psoriasis in the U.S. in 25 years
23 May 2022 - In the pivotal Phase 3 clinical trial program, Vtama cream met all primary and secondary endpoints and ...
Posted by Michael Wonder on 24 May 2022
ImmunityBio submits biologics license application for N-803 plus BCG for patients with BCG unresponsive non-muscle invasive bladder cancer carcinoma in situ
23 May 2022 - Results for this FDA designated breakthrough therapy exceed historical complete response rates and duration of response ...
Posted by Michael Wonder on 24 May 2022
ImmunoGen announces acceptance of biologics license application for mirvetuximab soravtansine in ovarian cancer by US Food and Drug Administration with priority review
23 May 2022 - PDUFA date is 28 November 2022. ...
Posted by Michael Wonder on 24 May 2022
Nymox receives RTF letter from FDA
23 May 2022 - Nymox Pharmaceutical Corporation reports today that it has received a refusal to file letter from FDA ...
Posted by Michael Wonder on 23 May 2022
US FDA accepts for review Biohaven's new drug application filing of intranasal zavegepant for the acute treatment of migraine
23 May 2022 - If approved, zavegepant nasal spray would be the only FDA approved calcitonin gene related peptide receptor antagonist ...
Posted by Michael Wonder on 22 May 2022
Patients deserve immediate access to FDA approved innovations — not bureaucratic restrictions
21 May 2022 - Innovation is the lifeblood that has made America the most economically successful nation in the modern era. ...
Posted by Michael Wonder on 21 May 2022
Bonesupport receives market authorisation for Cerement G in the US
18 May 2022 - BoneSupport today announced that the company has received market authorisation from the U.S. FDA, for the ...
Posted by Michael Wonder on 21 May 2022
FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukaemia
20 May 2022 - Today the FDA approved azacitidine (Vidaza, Celgene) for paediatric patients with newly diagnosed juvenile myelomonocytic leukaemia. ...
Posted by Michael Wonder on 20 May 2022
FDA approves first treatment for eosinophilic esophagitis, a chronic immune disorder
20 May 2022 - Today, the U.S. Food and Drug Administration approved Dupixent (dupilumab) to treat eosinophilic esophagitis in adults and ...
Posted by Michael Wonder on 20 May 2022
AbbVie submits new drug application to U.S. FDA for investigational ABBV-951 (foscarbidopa/foslevodopa) for the treatment of advanced Parkinson's disease
20 May 2022 - Submission is supported by Phase 3 study that demonstrated patients had significant increases in hours of ...