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RSS FeedPosted 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 ...
Posted by Michael Wonder on 02 Apr 2021
AbbVie announces extension of review for supplemental new drug application of upadacitinib for the treatment of moderate to severe atopic dermatitis
2 April 2021 - AbbVie announced that the U.S. FDA has extended the review period for the supplemental new drug application ...
Posted by Michael Wonder on 01 Apr 2021
FDA grants breakthrough therapy designation for Taiho Oncology's futibatinib for treatment of advanced cholangiocarcinoma
1 April 2021 - Taiho Oncology today announced that the U.S. FDA has granted breakthrough therapy designation for futibatinib (TAS-120), a ...
Posted by Michael Wonder on 31 Mar 2021
FDA approves Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma
31 March 2021 - While the median progression free survival for Sarclisa combination therapy is not yet reached, consistent improvement in ...
Posted by Michael Wonder on 31 Mar 2021
Premia Spine announces FDA breakthrough device designation for its TOPS spinal arthroplasty system
31 March 2021 - First-of-a-kind system designed to offer new treatment option for patients with spinal stenosis and spondylolisthesis. ...
Posted by Michael Wonder on 31 Mar 2021
Bluestar Genomics receives FDA breakthrough device designation for first-of-its-kind pancreatic cancer screening test
31 March 2021 - Company accelerates commercialisation efforts to address a million at-risk patients’ unmet needs. ...
Posted by Michael Wonder on 31 Mar 2021
Biden in no rush to pick new FDA chief
30 March 2021 - More than two months into his presidency, President Joe Biden has yet to name someone to lead ...
Posted by Michael Wonder on 31 Mar 2021
Jazz Pharmaceuticals announces FDA approval of additional indication for Vyxeos (daunorubicin and cytarabine) for the treatment of secondary acute myeloid leukaemia in paediatric patients
30 March 2021 - Jazz Pharmaceuticals today announced that the U.S. FDA approved a revised label for Vyxeos (daunorubicin and ...
Posted by Michael Wonder on 31 Mar 2021
Evive Biotech submits biologics license application to US FDA for Ryzneuta
31 March 2021 - Evive is the first Chinese biologics company to advance a novel biologic product from pre-clinical studies to ...
Posted by Michael Wonder on 30 Mar 2021
Moleculin receives FDA approval of fast track designation for annamycin in the treatment of sarcoma lung metastases
30 March 2021 - Moleculin Biotech today announced that the U.S. FDA has approved its request for fast track designation for ...