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RSS FeedPosted by Michael Wonder on 12 Oct 2020
Inventiva receives FDA breakthrough therapy designation for lead drug candidate lanifibranor in NASH
12 October 2020 - Inventiva today announced that the U.S. FDA has granted breakthrough therapy designation to lanifibranor, the Company’s lead ...
Posted by Michael Wonder on 05 Oct 2020
Real world evidence from a narrow therapeutic index product (levothyroxine) reflects the therapeutic equivalence of generic drug product
5 October 2020 - The National Institute of Diabetes and Digestive and Kidney Diseases reports that almost 5% of the U.S. ...
Posted by Michael Wonder on 25 Sep 2020
Innova Therapeutics receives rare paediatric disease designation from the FDA for IVT-8086 for the treatment of osteosarcoma
24 September 2020 - Innova Therapeutics Inc., a biopharmaceutical company committed to developing innovative cancer therapies for patients who have inadequate ...
Posted by Michael Wonder on 17 Jun 2020
A mad scramble to stock millions of malaria pills, likely for nothing
16 June 2020 - Before the F.D.A. withdrew its waiver to stockpile the drugs as coronavirus treatments, the Trump administration had ...
Posted by Michael Wonder on 11 Nov 2019
Lipocine receives complete response letter for Tlando from U.S. FDA
11 November 2019 - Lipocine announced today that it has received a complete response letter from the United States Food ...
Posted by Michael Wonder on 05 Nov 2019
Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo (pegfilgrastim-bmez)
5 November 2019 - Ziextenzo is indicated to decrease the incidence of febrile neutropenia, one of the most serious side effects ...
Posted by Michael Wonder on 12 Sep 2019
When are RCTs required for breakthrough drugs, HDEs? JAMA study investigates
11 September 2019 - A new study in JAMA Network Open finds that drugs and medical devices approved by the ...
Posted by Michael Wonder on 28 Aug 2019
Promoting paediatric drug research and labelling — outcomes of legislation
28 August 2019 - Congress has modified regulations of the FDA to promote research assessing the efficacy and safety of drugs ...
Posted by Michael Wonder on 26 Jul 2019
Matinas BioPharma receives qualified infectious disease product and fast track designations from U.S. FDA for MAT2203 for the treatment of cryptococcal meningitis
25 July 2019 - Fourth QIDP and fast track designations granted by FDA for MAT2203. ...
Posted by Michael Wonder on 05 Jun 2019
Pfizer knew drug may prevent Alzheimer's. Why didn't it tell us?
5 June 2019 - A team of researchers inside Pfizer made a startling find in 2015: the company's blockbuster rheumatoid ...
Posted by Michael Wonder on 06 May 2019
Esperion announces U.S. FDA acceptance of new drug applications for both bempedoic acid and the bempedoic acid with ezetimibe combination tablet for filing and regulatory review
5 May 2019 - 21 February 2020 PDUFA target date goal for bempedoic acid and 26 February 2020 PDUFA target ...
Posted by Michael Wonder on 01 May 2019
FDA approves Kalydeco (ivacaftor) as first and only CFTR modulator to treat eligible infants with CF as early as six months of age
30 April 2019 - Safety data from Phase 3 ARRIVAL study support treatment with Kalydeco in children ages six to <12 ...
Posted by Michael Wonder on 07 Apr 2019
Gilead submits supplemental new drug application to U.S. FDA for once daily Descovy for HIV pre-exposure prophylaxis
5 April 2019 - Filing supported by data demonstrating non-inferiority compared to Truvada coupled with bone and renal safety advantages in ...
Posted by Michael Wonder on 02 Jun 2018
Amgen statement on complete response letter from the U.S. FDA for ABP 980, a biosimilar candidate to Herceptin (trastuzumab)
1 June 2018 - Amgen received a complete response letter from the US FDA in response to the biologics license ...
Posted by Michael Wonder on 15 May 2018
Aerie Pharmaceuticals submits new drug application to U.S. FDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
15 May 2018 - Submitted as a 505(b)(2) with an expected ten month FDA review. ...