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RSS FeedPosted by Michael Wonder on 02 Mar 2022
Pfizer granted FDA breakthrough therapy designation for respiratory syncytial virus (RSV) vaccine candidate for the prevention of RSV in infants from birth up to six months of age by active immunisation of pregnant women
2 March 2022 - Pfizer today announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, received breakthrough ...
Posted by Michael Wonder on 02 Mar 2022
Advanced Innovative Partners announces designation for rare paediatric disease drug
1 March 2022 - AIP is pleased to announce that the U.S Food and Drug Administration (FDA) has granted Orphan Drug ...
Posted by Michael Wonder on 28 Feb 2022
AbbVie seeks new indication for Imbruvica (ibrutinib) in paediatric patients with chronic graft versus host disease
28 February 2022 - The sNDA and NDA submissions were primarily based on results of three years of data from ...
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 12 Feb 2022
Pfizer and BioNTech provide update on rolling submission for emergency use authorisation of their COVID-19 vaccine in children 6 months through 4 years of age
11 February 2022 - Pfizer and BioNTech today announced plans to extend their rolling submission to the U.S. FDA seeking ...
Posted by Michael Wonder on 10 Feb 2022
FDA accepts Dupixent (dupilumab) for priority review in children aged 6 months to 5 years with moderate to severe atopic dermatitis
10 February 2022 - If approved, Dupixent will be the first biologic medicine available in the U.S. to treat uncontrolled ...
Posted by Michael Wonder on 02 Feb 2022
QSAM Biosciences receives rare paediatric disease designation from FDA for CycloSam in the treatment of osteosarcoma
2 February 2022 - QSAM Biosciences today announces that the United States FDA has granted rare paediatric disease designation to ...
Posted by Michael Wonder on 01 Feb 2022
Pfizer and BioNTech initiate rolling submission for emergency use authorisation of their COVID-19 vaccine in children 6 months through 4 years of age following request from U.S. FDA
1 February 2022 - Companies plan to submit additional data on a third 3 µg dose in this age group in ...
Posted by Michael Wonder on 27 Jan 2022
Lantern Pharma receives rare paediatric disease and orphan drug designations for LP-184 for the treatment of atypical teratoid rhabdoid tumour
24 January 2022 - Lantern Pharma today announced that the U.S. FDA has granted both rare paediatric disease designation and orphan ...
Posted by Michael Wonder on 26 Jan 2022
Catalyst Biosciences receives rare paediatric disease designation for CB 4332 for the treatment of CFI deficiency
25 January 2022 - Catalyst Biosciences today announced the U.S. FDA has granted rare paediatric disease designation for CB 4332 for ...
Posted by Michael Wonder on 25 Jan 2022
Genentech’s Evrysdi (risdiplam) granted FDA priority review for treatment of presymptomatic babies under 2 months of age with spinal muscular atrophy
24 January 2022 - Interim data submitted to the FDA show majority of pre-symptomatic babies treated with Evrysdi for at least ...
Posted by Michael Wonder on 21 Jan 2022
Pfizer and OPKO provide update on the biologics license application for somatrogon for paediatric growth hormone deficiency
21 January 2022 - Pfizer and OPKO Health announced today that the U.S. FDA issued a complete response letter for the ...
Posted by Michael Wonder on 07 Jan 2022
Otsuka and Lundbeck announce FDA approval of supplemental new drug application for Rexulti (brexpiprazole) to treat schizophrenia in paediatric patients ages 13-17
6 January 2022 - Otsuka and Lundbeck announce the U.S. FDA has approved the supplemental new drug application of Rexulti ...
Posted by Michael Wonder on 05 Jan 2022
U.S. FDA approves Immix Biopharma rare paediatric disease designation for IMX-110 as a treatment for life-threatening paediatric cancer
3 January 2021 - Immix Biopharma announced today that the U.S. FDA has granted rare paediatric disease designation for IMX-110 for ...
Posted by Michael Wonder on 03 Jan 2022
FDA takes multiple actions to expand use of Pfizer-BioNTech COVID-19 Vaccine
3 January 2021 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 Vaccine to: ...