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RSS FeedPosted by Michael Wonder on 03 Aug 2020
FDA grants fast track designation for BCX9930 in PNH
3 August 2020 - BioCryst Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for its oral ...
Posted by Michael Wonder on 03 Aug 2020
Sonoran Biosciences announces qualified infectious disease product designation granted by FDA for SBG003 for surgical site infections in abdominal surgery
3 August 2020 - QIDP designation allows for FDA priority review, fast-track designation and an additional five years of market exclusivity ...
Posted by Michael Wonder on 03 Aug 2020
Imara announces IMR-687 granted fast track designation and rare paediatric disease designation for treatment of beta-thalassaemia
30 July 2020 - Imara today announced the U.S. FDA has granted fast track designation and rare paediatric disease designation for ...
Posted by Michael Wonder on 03 Aug 2020
Characteristics and strength of evidence of COVID-19 studies registered on ClinicalTrials.gov
27 July 2020 - The coronavirus disease 2019 (COVID-19) pandemic has led to a massive activation of clinical research. ...
Posted by Michael Wonder on 01 Aug 2020
FDA approves new indication for drug containing an active ingredient derived from cannabis to treat seizures in rare genetic disease
31 July 2020 - Today, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) oral solution for the treatment of seizures ...
Posted by Michael Wonder on 01 Aug 2020
FDA approves Monjuvi (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma
31 July 2020 - First FDA approval of a second-line treatment for adult patients with relapsed or refractory diffuse large B-cell ...
Posted by Michael Wonder on 31 Jul 2020
Medicare expands coverage for BRACAnalysis CDx in prostate cancer
31 July 2020 - Myriad Genetics announced today that Medicare has expanded coverage for BRACAnalysis CDx for men with prostate cancer ...
Posted by Michael Wonder on 31 Jul 2020
Weighing the benefits and risks of proliferating observational treatment assessments: observational cacophony, randomised harmony
31 July 2020 - Amid the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, substantial effort is being directed toward ...
Posted by Michael Wonder on 31 Jul 2020
Tagrisso granted breakthrough therapy designation in the US for the adjuvant treatment of patients with Stage IB-IIIA EGFR mutated lung cancer
30 July 2020 - Designation based on unprecedented results from the Phase III ADAURA trial where Tagrisso reduced the risk of ...
Posted by Michael Wonder on 31 Jul 2020
U.S. Food and Drug Administration approves Stelara (ustekinumab) for treatment of paediatric patients with moderate to severe plaque psoriasis
30 July 2020 - Stelara is the first and only biologic to target interleukin (IL)-12 and IL-23 approved for paediatric psoriasis ...
Posted by Michael Wonder on 31 Jul 2020
Sanofi and GSK selected for Operation Warp Speed to supply United States government with 100 million doses of COVID-19 vaccine
31 July 2020 - Promising vaccine candidate selected by U.S. government’s Operation Warp Speed. ...
Posted by Michael Wonder on 30 Jul 2020
Marinus Pharmaceuticals receives rare paediatric disease designation from FDA for ganaxolone for the treatment of CDKL5 deficiency disorder
30 July 2020 - Marinus Pharmaceuticals announced today that the U.S. FDA has granted rare paediatric disease designation for the ...
Posted by Michael Wonder on 30 Jul 2020
Takeda announces U.S. FDA breakthrough therapy designation granted for pevonedistat for the treatment of patients with higher-risk myelodysplastic syndromes
30 July 2020 - Designation based on Phase 2 data and reinforces significant treatment need for higher-risk myelodysplastic syndrome. ...
Posted by Michael Wonder on 30 Jul 2020
FDA approves Genentech’s Tecentriq plus Cotellic and Zelboraf for people with advanced melanoma
30 July 2020 - Genentech today announced that the U.S. FDA approved Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) ...
Posted by Michael Wonder on 30 Jul 2020
Merck announces two US regulatory milestones for Keytruda (pembrolizumab) in triple-negative breast cancer
30 July 2020 - FDA grants priority review to supplemental biologics license application for Keytruda plus chemotherapy for the treatment of ...