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RSS FeedPosted by Michael Wonder on 01 May 2023
US FDA issues complete response letter for TransCon PTH in hypoparathyroidism
1 May 2023 - FDA cited concerns related to the manufacturing control strategy for variability of delivered dose in the TransCon ...
Posted by Michael Wonder on 01 May 2023
US FDA accepts for priority review supplemental biologics license application and EMA validates application for Reblozyl (luspatercept-aamt) as first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes
1 May 2023 - Applications based on results from Phase 3 COMMANDS study in which first-in-class Reblozyl demonstrated a highly statistically ...
Posted by Michael Wonder on 30 Apr 2023
Teva and MedinCell announce FDA approval of Uzedy (risperidone) extended-release injectable suspension, a long-acting subcutaneous atypical antipsychotic injection, for the treatment of schizophrenia in adults
28 April 2023 - In a Phase 3 clinical trial, Uzedy demonstrated up to 80% reduction in risk of schizophrenia relapse ...
Posted by Michael Wonder on 28 Apr 2023
FDA approves Otsuka and Lundbeck’s Abilify Asimtufii (aripiprazole), the first once every two months long-acting injectable for the treatment of schizophrenia or maintenance monotherapy treatment of bipolar I disorder in adults
27 April 2023 - Otsuka and Lundbeck announce the US FDA has approved the new drug application for Abilify Asimtufii (aripiprazole) ...
Posted by Michael Wonder on 28 Apr 2023
Takeda announces FDA acceptance of BLA resubmission for investigational subcutaneous administration of Entyvio (vedolizumab) for maintenance therapy in moderately to severely active ulcerative colitis
27 April 2023 - Takeda today announced that the US FDA)has accepted for review its biologics license application resubmission for ...
Posted by Michael Wonder on 28 Apr 2023
US FDA approves Prevnar 20, Pfizer’s 20 valent pneumococcal conjugate vaccine for infants and children
27 April 2023 - Prevnar 20 offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine, helping to protect ...
Posted by Michael Wonder on 27 Apr 2023
Seres Therapeutics and Nestlé Health Science announce FDA approval of Vowst (fecal microbiota spores, live-brpk) for prevention of recurrence of C. difficile infection in adults following antibacterial treatment for recurrent CDI
26 April 2023 - First and only FDA approved orally administered microbiota-based therapeutic, validating Seres’ microbiome platform. ...
Posted by Michael Wonder on 26 Apr 2023
Vertex announces US FDA approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 2 through 5 with certain mutations
26 April 2023 - About 900 children with cystic fibrosis will now have a medicine to treat the underlying cause of ...
Posted by Michael Wonder on 26 Apr 2023
Atea Pharmaceuticals announces US FDA fast track designation granted to bemnifosbuvir, an investigational oral anti-viral, for the treatment of COVID-19
25 April 2023 - Atea Pharmaceuticals today announced that the United States FDA has granted fast track designation to bemnifosbuvir for ...
Posted by Michael Wonder on 25 Apr 2023
FDA grants accelerated approval for Qalsody (tofersen) for SOD1-ALS, a major scientific advancement as the first treatment to target a genetic cause of ALS
25 April 2023 - FDA granted accelerated approval of Qalsody based on a reduction of neurofilament, a marker of neurodegeneration. ...
Posted by Michael Wonder on 25 Apr 2023
bluebird bio submits biologics license application to FDA for lovotibeglogene autotemcel (lovo-cel) for patients with sickle cell disease 12 years and older with a history of vaso-occlusive events
24 April 2023 - BLA submission based on data from the largest and most mature clinical development program for any ...
Posted by Michael Wonder on 24 Apr 2023
Avidity Biosciences granted FDA fast track designation for AOC 1044 for treatment of Duchenne muscular dystrophy mutations amenable to exon 44 skipping
24 April 2023 - Avidity Biosciences today announced that the US FDA has granted fast track designation to AOC 1044 for ...
Posted by Michael Wonder on 24 Apr 2023
Lantheus and POINT Biopharma announce FDA grants fast track designation for ¹⁷⁷Lu-PNT2002 for the treatment of metastatic castration resistant prostate cancer
24 April 2023 - Lantheus Holdings today announced the US FDA has granted fast track designation for 177Lu-PNT2002 for the treatment ...
Posted by Michael Wonder on 22 Apr 2023
Canada says it could offer access to mifepristone if the abortion drug is banned in the US
22 April 2023 - A Canadian health official said on Friday Americans could access an abortion drug up north if ...
Posted by Michael Wonder on 22 Apr 2023
Mifepristone: US Supreme Court preserves abortion drug access
22 April 2023 - The US Supreme Court has preserved access to a commonly used abortion pill, ruling the drug ...