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RSS FeedPosted 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 10 May 2021
FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic
10 May 2021 - Today, the U.S. FDA expanded the emergency use authorisation for the Pfizer-BioNTech COVID-19 vaccine for the prevention ...
Posted by Michael Wonder on 09 May 2021
‘In their own bubble’: How a cancer center promoted an exclusive experimental drug to attract patients
6 May 2021 - A new medication for children with a rare and life-threatening cancer called neuroblastoma had a curious ...
Posted by Michael Wonder on 05 May 2021
Pfizer says it will seek clearance in September for its vaccine to be used in children aged 2 to 11
4 May 2021 - Pfizer expects to apply to the FDA in September for emergency authorisation to administer its coronavirus ...
Posted by Michael Wonder on 27 Apr 2021
Enzyvant resubmits biologics licence application to FDA for RVT-802 for paediatric congenital athymia
27 April 2021 - Enzyvant today announced the resubmission of the biologics licence application to the U.S. FDA for RVT-802, ...
Posted by Michael Wonder on 19 Apr 2021
ALK gains paediatric approval for its ragweed SLIT tablet in the USA
19 April 2021 - The approval is based on data from one of the largest-ever paediatric SLIT-tablet trials, involving over 1,000 ...
Posted by Michael Wonder on 14 Apr 2021
Moleculin awarded new rare paediatric disease designation from U.S. FDA for WP1066 for the treatment of ependymoma
14 April 2021 - Moleculin Biotech announced today that the U.S. FDA has granted rare paediatric disease designation to its ...
Posted by Michael Wonder on 05 Apr 2021
FDA approvals strengthen Octapharma USA paediatric critical care product portfolio
30 March 2021 - Octaplas and fibryga receive new product labeling following FDA’s approval of BLA supplements to update therapy ...
Posted by Michael Wonder on 29 Mar 2021
Mezzion announces resubmission of new drug application for its orphan drug udenafil to treat patients who have undergone the Fontan operation for single ventricle heart disease
28 March 2021 - Submitted for FDA priority review as a rare paediatric disease product application. ...
Posted by Michael Wonder on 25 Mar 2021
FDA approves new indication for drug to treat neurogenic detrusor overactivity in paediatric patients
25 March 2021 - Today, the U.S. FDA approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron ...
Posted by Michael Wonder on 23 Mar 2021
Pacira announces FDA approval of supplemental new drug application for Exparel (bupivacaine liposome injectable suspension) in paediatric patients
22 March 2021 - Exparel is the first and only FDA approved long-acting local analgesic for children aged six and over. ...
Posted by Michael Wonder on 09 Mar 2021
Seqirus announces U.S. FDA approval of expanded age indication of its cell based quadrivalent influenza vaccine for people two years of age and older
5 March 2021 - Seqirus today announced that the U.S. FDA has approved Flucelvax Quadrivalent (influenza vaccine), the company's cell-based quadrivalent ...
Posted by Michael Wonder on 04 Mar 2021
FDA accepts Dupixent (dupilumab) for review in children with moderate to severe asthma
4 March 2021 - Submission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to ...
Posted by Michael Wonder on 26 Feb 2021
Retrotope granted rare paediatric disease designation from FDA for lead development candidate, RT001, in two life-threatening neurodegenerative indications
25 February 2021 - RT001 also granted fast track designation by FDA in Friedreich’s ataxia. ...
Posted by Michael Wonder on 25 Feb 2021
Humira (adalimumab) receives FDA approval to treat paediatric patients living with moderately to severely active ulcerative colitis
24 February 2021 - Humira (adalimumab) is the first and only subcutaneous biologic treatment option for paediatric patients from 5 years ...