Blog
RSS FeedPosted by Michael Wonder on 17 May 2021
Biogen hopes Alzheimer’s drug mired in controversy earns FDA nod
13 May 2021 - After scores of failures, regulators are set to rule on aducanumab, which promises to slow dementia. ...
Posted by Michael Wonder on 17 May 2021
Adamis Pharmaceuticals resubmits Zimhi new drug application to FDA for the treatment of opioid overdose
17 May 2021 - Adamis Pharmaceuticals today announced that the new drug application was resubmitted to the U.S. FDA for ...
Posted by Michael Wonder on 15 May 2021
Apellis announces U.S. FDA approval of Empaveli (pegcetacoplan) for adults with paroxysmal nocturnal hemoglobinuria
14 May 2021 - Empaveli was superior to Soliris for the change from baseline in haemoglobin level at Week 16 in ...
Posted by Michael Wonder on 14 May 2021
BridgeBio Pharma receives FDA fast track designation for investigational gene therapy for congenital adrenal hyperplasia
14 May 2021 - BridgeBio Pharma today announced that the U.S. FDA granted fast track designation to BBP-631, an investigational adeno-associated ...
Posted by Michael Wonder on 14 May 2021
PharmaEssentia resubmits application to the U.S. FDA for ropeginterferon alfa-2b-njft to treat polycythemia vera
14 May 2021 - PharmaEssentia today announced the resubmission of its biologics license application to the U.S. FDA, seeking approval for ...
Posted by Michael Wonder on 14 May 2021
Vaccine patent waivers deserve a warning label
13 May 2021 - The move to suspend patents on COVID-19 vaccines opens up a major risk to the way the ...
Posted by Michael Wonder on 14 May 2021
Molzym announces FDA breakthrough device designation for its molecular diagnostic test system – sepsis, ioint & implant infections, infective endocarditis, bacterial meningitis
10 May 2021 - Molzym’s unique technology for molecular microbial diagnostics was granted breakthrough device designation by the FDA in light ...
Posted by Michael Wonder on 13 May 2021
Strongbridge Biopharma announces U.S. FDA filing acceptance of new drug application for Recorlev (levoketoconazole) for the treatment of endogenous Cushing’s syndrome
13 May 2021 - FDA Sets Prescription Drug User Fee Act target action date of 1 January 2022. ...
Posted by Michael Wonder on 13 May 2021
Palisade Bio receives FDA fast track designation for LB1148 for reduction of adhesions following abdominal and pelvic surgery
13 May 2021 - LB1148 was previously granted fast track designation from the U.S. FDA for the treatment of post-operative GI ...
Posted by Michael Wonder on 13 May 2021
Heron Therapeutics announces U.S. FDA approval of Zynrelef for the management of post-operative pain for up to 72 hours
13 May 2021 - Full U.S. commercial launch of Zynrelef is planned for July 2021. ...
Posted by Michael Wonder on 13 May 2021
Fulcrum Therapeutics announces U.S. FDA grants fast track designation to losmapimod for the potential treatment of facioscapulohumeral muscular dystrophy
12 May 2021 - Fulcrum Therapeutics today announced that the U.S. FDA has granted fast track designation to losmapimod for ...
Posted by Michael Wonder on 12 May 2021
Evofem Biosciences receives fast track designation for EVO100 for prevention of gonorrhoea in women
12 May 2021 - Potential for expedited NDA review of EVO100 by FDA. ...
Posted by Michael Wonder on 12 May 2021
Alume Biosciences granted FDA fast track designation of ALM-488 for surgical nerve visualisation
12 May 2021 - Fast track designation highlights the urgent need for improved intra-operative nerve identification. ...
Posted by Michael Wonder on 12 May 2021
Liquidia resubmits new drug application for LIQ861 (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension
10 May 2021 - Liquidia Corporation announced today that on 7 May 2021, it resubmitted its new drug application for LIQ861 ...
Posted by Michael Wonder on 12 May 2021
DermaSensor granted FDA breakthrough device designation
11 May 2021 - FDA designation fast tracks getting cancer detection device in the hands of healthcare professionals ...