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RSS FeedPosted by Michael Wonder on 21 Nov 2018
FDA approves new treatment for patients with acute myeloid leukaemia
21 November 2018 - The U.S. FDA today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine, for ...
Posted by Michael Wonder on 20 Nov 2018
FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease
20 November 2018 - The U.S. FDA today approved Gamifant (emapalumab) for the treatment of paediatric (newborn and above) and ...
Posted by Michael Wonder on 18 Nov 2018
Aquestive Therapeutics receives complete response letter from U.S. FDA for tadalafil oral film
16 November 2018 - Aquestive Therapeutics today announced it received a complete response letter from the U.S. FDA in regards to ...
Posted by Michael Wonder on 17 Nov 2018
FDA approves Novartis drug Promacta for first-line SAA and grants breakthrough therapy designation for additional new indication
16 November 2018 - Promacta receives FDA approval for first-line treatment of severe aplastic anaemia and breakthrough therapy designation for low ...
Posted by Michael Wonder on 17 Nov 2018
FDA approves new drug to treat travelers’ diarrhoea
16 November 2018 - The U.S. FDA today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients ...
Posted by Michael Wonder on 16 Nov 2018
FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot
16 November 2018 - The U.S. FDA today expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy ...
Posted by Michael Wonder on 15 Nov 2018
Stallergenes Greer announces U.S. FDA approval of paediatric indication extension for Oralair sublingual immunotherapy tablet for the treatment of grass pollen allergy
14 November 2018 - Stallergenes Greer today announced that it has received approval from the U.S. FDA for the extension of ...
Posted by Michael Wonder on 14 Nov 2018
Pain Therapeutics appeals FDA decision on Remoxy
12 November 2018 - Pain Therapeutics today announced that it has petitioned the FDA regarding a complete response letter for ...
Posted by Michael Wonder on 10 Nov 2018
Theravance Biopharma and Mylan receive FDA approval for Yuperli (revefenacin) in adults with chronic obstructive pulmonary disease
9 November 2018 - Yuperli (revefenacin) is the first and only once-daily, nebulised bronchodilator approved for the treatment of COPD in ...
Posted by Michael Wonder on 10 Nov 2018
FDA highlights record-breaking number of generic drug approvals in October
9 November 2018 - Today, the U.S. FDA is providing a summary of the generic drug approval actions for the ...
Posted by Michael Wonder on 10 Nov 2018
FDA approves Merck’s Keytruda (pembrolizumab) for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib
10 November 2018 - Approval marks 14th indication for Keytruda. ...
Posted by Michael Wonder on 07 Nov 2018
U.S. FDA approves Empliciti (elotuzumab) plus pomalidomide and dexamethasone, a new immunotherapy combination for certain patients with relapsed or refractory multiple myeloma
6 November 2018 - In the ELOQUENT-3 trial, treatment with Empliciti plus pomalidomide and dexamethasone doubled median progression-free survival and overall ...
Posted by Michael Wonder on 06 Nov 2018
FDA approves novel single-vial formulation of Egrifta
5 November 2018 - Theratechnologies is pleased to announce that the FDA in the United States has approved the new ...
Posted by Michael Wonder on 05 Nov 2018
Aquestive Therapeutics announces U.S. FDA approval for Sympazan (clobazam) oral film
2 November 2018 - Sympazan is delivered via Aquestive's proprietary PharmFilm technology. ...
Posted by Michael Wonder on 04 Nov 2018
U.S. FDA approves Lorbrena (lorlatinib) for previously treated ALK-positive metastatic non-small cell lung cancer
2 November 2018 - Lorbrena addresses unmet needs for certain patients treated with prior ALK therapy. ...