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RSS FeedPosted by Michael Wonder on 30 Jan 2019
Duchesnay receives approval of supplemental new drug application to add moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy due to menopause, to the indication of Osphena (ospemifene)
29 January 2019 - Duchesnay announced today that the FDA has approved its supplemental new drug application seeking to add moderate ...
Posted by Michael Wonder on 24 Jan 2019
BMS announces voluntary withdrawal of U.S. application for Opdivo plus low dose Yervoy for treatment of first-line lung cancer in patients with tumor mutational burden ≥10 mutations/megabase, following discussions with the U.S. FDA
24 January 2019 - Following recent discussions with the U.S. FDA, the company today announced the voluntary withdrawal of the ...
Posted by Michael Wonder on 24 Jan 2019
U.S. FDA accepts sNDAs for Pifeltro (doravirine) and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate)
23 January 2019 - Potential new indication would expand use to allow treatment-experienced adults living with HIV-1 whose virus is suppressed ...
Posted by Michael Wonder on 24 Jan 2019
Genmab announces initiation of U.S. FDA regulatory submission for label expansion of daratumumab in combination with lenalidomide and dexamethasone in front line multiple myeloma
22 January 2019 - First part of regulatory package submitted to the U.S. FDA for label expansion of daratumumab in combination ...
Posted by Michael Wonder on 18 Jan 2019
FDA accepts Roche’s supplemental biologics license application for Tecentriq plus chemotherapy (Abraxane and carboplatin) for the initial treatment of metastatic non-squamous non-small cell lung cancer
17 January 2019 - Roche today announced that the US FDA has accepted the company’s supplemental biologics license application for Tecentriq ...
Posted by Michael Wonder on 17 Jan 2019
After 37 years of trying, this biotech nears a first drug approval in breast cancer
16 January 2019 - Immunomedics was founded in 1982. Thirty-seven years later, the biotech is finally on the cusp of ...
Posted by Michael Wonder on 17 Jan 2019
FDA review of Aimmune drug put on hold due to government shutdown
14 January 2019 - The ongoing partial shutdown of the U.S. government has temporarily derailed biotech Aimmune Therapeutics' bid to win ...
Posted by Michael Wonder on 17 Jan 2019
New drug application for insomnia disorder treatment lemborexant submitted in the United States
15 January 2019 - Eisai Co., Ltd. (CEO: Haruo Naito, “Eisai”) and Purdue Pharma L.P. (President and CEO: Craig Landau, MD, ...
Posted by Michael Wonder on 15 Jan 2019
Nabriva Therapeutics provides update on PDUFA date for intravenous Contepo
14 January 2019 - PDUFA action date now set for 30 April 2019. ...
Posted by Michael Wonder on 14 Jan 2019
US FDA accepts regulatory submissions for review of tafamidis to treat transthyretin amyloid cardiomyopathy
14 January 2019 - FDA grants a priority review based on Phase 3 ATTR-ACT study findings. ...
Posted by Michael Wonder on 12 Jan 2019
Ocular Therapeutix submits supplemental new drug application for Dextenza (dexamethasone ophthalmic insert) for the treatment of ocular inflammation following ophthalmic surgery
10 January 2019 - Application expands the current Dextenza post-operative pain label as the first intra-canalicular insert for drug delivery. ...
Posted by Michael Wonder on 07 Jan 2019
ADMA Biologics submits response and provides supplemental information to FDA for Bivigam complete response letter
7 January 2019 - ADMA Biologics announces that the Company has submitted responses to the U.S. FDA complete response letter received ...
Posted by Michael Wonder on 06 Jan 2019
Nabriva Therapeutics announces acceptance of the new drug application for intravenous Contepo to treat complicated urinary tract infections by FDA
4 January 2019 - PDUFA action date set for 30 June 2019. ...
Posted by Michael Wonder on 01 Jan 2019
Adamis Pharmaceuticals submits new drug application to FDA for its naloxone pre-filled syringe
31 December 2018 - Adamis Pharmaceuticals today announced the submission of a new drug application to the U.S. Food and ...
Posted by Michael Wonder on 30 Dec 2018
Adamis Pharmaceuticals submits new drug application to FDA for its tadalafil sublingual tablet
28 December 2018 - -- Adamis Pharmaceuticals today announced the submission of a new drug application to the U.S. FDA ...