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RSS FeedPosted by Michael Wonder on 01 Jun 2021
BridgeBio Pharma receives FDA fast track designation for encaleret for the treatment of autosomal dominant hypocalcaemia type 1
1 June 2021 - BridgeBio Pharma today announced that the U.S. FDA granted fast track designation for encaleret for the treatment ...
Posted by Michael Wonder on 01 Jun 2021
Moderna announces initiation of rolling submission of biologics license application with US FDA for the Moderna COVID-19 vaccine
1 June 2021 - Moderna today announced that it has initiated the rolling submission process with the U.S. FDA for ...
Posted by Michael Wonder on 01 Jun 2021
Lannett announces FDA acceptance, as a priority original ANDA, of the generic Advair Diskus filing
1 June 2021 - Lannett today announced the U.S. FDA has accepted the abbreviated new drug application for fluticasone propionate and ...
Posted by Michael Wonder on 01 Jun 2021
Paratek Pharmaceuticals announces FDA approval of Nuzyra (omadacycline) oral only dosing regimen for the treatment of community-acquired bacterial pneumonia
1 June 2021 - Oral only dosing for the treatment of CABP expands the commercial opportunity for primary care promotion. ...
Posted by Michael Wonder on 01 Jun 2021
Mycovia Pharmaceuticals submits new drug application to the U.S. FDA for oteseconazole for the treatment of recurrent vulvovaginal candidiasis
1 June 2021 - Oteseconazole’s qualified infectious disease product and fast track designations allow for six month priority review by FDA ...
Posted by Michael Wonder on 01 Jun 2021
Alkermes announces FDA approval of Lybalvi for the treatment of schizophrenia and bipolar I disorder
1 June 2021 - Commercial launch planned for fourth quarter 2021. ...
Posted by Michael Wonder on 01 Jun 2021
Akebia and Otsuka announce FDA acceptance for filing of new drug application for vadadustat for the treatment of anaemia due to chronic kidney disease in adult patients on dialysis and not on dialysis
1 June 2021 - Vadadustat assigned PDUFA target action date of 29 March 2022. ...
Posted by Michael Wonder on 01 Jun 2021
BeyondSpring announces U.S. FDA acceptance and priority review of new drug application for plinabulin and G-CSF combination for the prevention of chemotherapy-induced neutropenia
1 June 2021 - The FDA has set a Prescription Drug User Fee Act target action date for 30 November 2021. ...
Posted by Michael Wonder on 31 May 2021
Suspend intellectual property rights for COVID-19 vaccines
28 May 2021 - Waivers are essential for global vaccine equity ...
Posted by Michael Wonder on 31 May 2021
Eton Pharmaceuticals receives complete response letter from U.S. FDA for dehydrated alcohol injection
28 May 2021 - Eton Pharmaceuticals today announced that the company has received a complete response letter from the U.S. FDA ...
Posted by Michael Wonder on 31 May 2021
If the FDA approves Biogen’s Alzheimer’s treatment, I won’t prescribe it
30 May 2021 - Most visits to the memory centre where I care for individuals living with Alzheimer’s disease end ...
Posted by Michael Wonder on 31 May 2021
FDA grants breakthrough device designation for smart orthopaedic implants
28 May 2021 - Intelligent Implants has announced today that its SmartFuse system has received breakthrough device designation by the ...
Posted by Michael Wonder on 29 May 2021
Ipsen confirms U.S. FDA accepts new drug application for palovarotene as the first potential treatment worldwide for fibrodysplasia ossificans progressiva
28 May 2021 - New drug application granted priority review status, with a decision anticipated on 30 November 2021. ...
Posted by Michael Wonder on 28 May 2021
FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma
28 May 2021 - Today, the FDA granted accelerated approval to infigratinib (Truseltiq, QED Therapeutics), a kinase inhibitor for adults ...
Posted by Michael Wonder on 28 May 2021
FDA approves first targeted therapy for lung cancer mutation previously considered resistant to drug therapy
28 May 2021 - Today, the U.S. Food and Drug Administration approved Lumakras (sotorasib) as the first treatment for adult patients ...