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RSS FeedPosted by Michael Wonder on 07 Apr 2021
Pfizer announces extension of review of new drug application of abrocitinib for the treatment of moderate to severe atopic dermatitis
7 April 2021 - Pfizer today announced that the U.S. FDA has extended the priority review period for the new ...
Posted by Michael Wonder on 07 Apr 2021
IceCure Medical granted FDA breakthrough device designation for Prosense cryoablation system
5 April 2021 - IceCure Medical announced today that it has been granted designation as a breakthrough device from the ...
Posted by Michael Wonder on 07 Apr 2021
FDA approves Althera’s Roszet (rosuvastatin and ezetimibe) tablets, a new oral therapy for powerful cholesterol reduction
31 March 2021 - Roszet is indicated for adults with primary non-familial hyperlipidaemia and homozygous familial hypercholesterolaemia. ...
Posted by Michael Wonder on 07 Apr 2021
Rare Disease Therapeutics announces new expanded FDA approved indication for antivenom Anavip for treatment of North American Pit Viper envenomation
5 April 2021 - Anavip now indicated for management of adult and paediatric patients with all North American Pit Viper envenomation, ...
Posted by Michael Wonder on 07 Apr 2021
TGA to review advertising of stem cell therapies to the Australian public
7 April 2021 - The Therapeutic Goods Administration, part of the Department of Health, is investigating the advertising of stem ...
Posted by Michael Wonder on 06 Apr 2021
Lilly and Incyte communicate review extension of supplemental new drug application for baricitinib for the treatment of moderate to severe atopic dermatitis
6 April 2021 - Eli Lilly and Incyte announced today that the U.S. FDA has extended the review period for ...
Posted by Michael Wonder on 06 Apr 2021
FDA makes two revisions to Moderna COVID-19 vaccine emergency use authorization to help increase the number of vaccine doses available
1 April 2021 - Today, the U.S. FDA announced two revisions regarding the number of doses per vial available for the ...
Posted by Michael Wonder on 06 Apr 2021
Statement by Acting Australian Government Chief Medical Officer, Professor Michael Kidd and Head of the Therapeutic Goods Administration Adjunct Professor John Skerritt
2 April 2021 - Australia's vaccine safety and regulatory process is world class and people can be confident that vaccines ...
Posted by Michael Wonder on 06 Apr 2021
Biofrontera submits application for FDA approval of new BF-RhodoLED XL lamp
31 March 2021 - Biofrontera today announced the submission for approval of a new, significantly larger red-light source for photodynamic therapy ...
Posted by Michael Wonder on 06 Apr 2021
Acadia Pharmaceuticals receives complete response letter from U.S. FDA for supplemental new drug application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis
5 April 2021 - Acadia Pharmaceuticals today announced that the Company has received a complete response letter from the U.S. FDA ...
Posted by Michael Wonder on 06 Apr 2021
Kite submits supplemental biologics license application to U.S. FDA for Tecartus in adult patients with relapsed or refractory acute lymphoblastic leukaemia
1 April 2021 - If approved, Tecartus would be the first and only CAR T-cell therapy approved for adult patients ...
Posted by Michael Wonder on 06 Apr 2021
United Therapeutics announces FDA approval and launch of Tyvaso for the treatment of pulmonary hypertension associated with interstitial lung disease
1 April 2021 - First and only approved therapy in the United States for patients with PH-ILD, a serious, life-threatening ...
Posted by Michael Wonder on 05 Apr 2021
BeyondSpring announces submission of new drug application to U.S. FDA and China NMPA for plinabulin and G-CSF combination for the prevention of chemotherapy-induced neutropenia
31 March 2021 - Applications are supported by positive PROTECTIVE-2 Phase 3 data demonstrating that plinabulin in combination with G-CSF offers ...
Posted by Michael Wonder on 05 Apr 2021
Supernus announces FDA approval of Qelbree (SPN-812) for the treatment of ADHD
2 April 2021 - Qelbree (viloxazine extended release capsules) represents the first novel non-stimulant treatment for ADHD in a decade. ...
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 ...