Blog
RSS FeedPosted by Michael Wonder on 31 May 2020
FDA approves the first oral medication for the management of heavy menstrual bleeding due to uterine fibroids in pre-menopausal women
29 May 2020 - Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) is expected to be available in the U.S. ...
Posted by Michael Wonder on 23 May 2020
U.S. FDA approves Evofem Biosciences' Phexxi (lactic acid, citric acid and potassium bitartrate), the first and only non-hormonal prescription gel for the prevention of pregnancy
22 May 2020 - A new class of female-controlled birth control for use in-the-moment. ...
Posted by Michael Wonder on 16 Apr 2020
Mayne Pharma submits new drug application for E4/DRSP to the FDA
16 April 2020 - Mayne Pharma and Mithra Pharmaceuticals today announced that Mayne Pharma has submitted a new drug application ...
Posted by Michael Wonder on 20 Feb 2020
Heron Therapeutics announces FDA extension of review period for NDA for HTX-011 for the management of post-operative pain
19 February 2020 - Updated Prescription Drug User Fee Act goal date is 26 June 2020. ...
Posted by Michael Wonder on 15 Feb 2020
FDA approves Agile Therapeutics' Twirla (levonorgestrel and ethinyl estradiol) transdermal system – a new weekly contraceptive patch delivering a 30 mcg daily dose of oestrogen and 120 mcg daily dose of progestin
14 February 2020 - Twirla is a new non-daily, non-invasive contraceptive approved in the U.S. ...
Posted by Michael Wonder on 04 Feb 2020
FDA accepts for review supplemental new drug application for Recarbrio (imipenem, cilastatin, and relebactam) for the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia
3 February 2020 - Filing receives priority review. ...
Posted by Michael Wonder on 22 Dec 2019
ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV
21 December 2019 - ViiV Healthcare, with Pfizer and Shionogi, has received a complete response letter from the US FDA regarding ...
Posted by Michael Wonder on 28 Nov 2019
Hikma completes its FDA response for generic Advair
27 November 2019 - Hikma Pharmaceuticals today announces that it has submitted to the US FDA its response to deficiencies in ...
Posted by Michael Wonder on 13 Nov 2019
Allergan receives FDA qualified infectious disease product designation and fast track designation for ATM-AVI (aztreonam and avibactam) for antibiotic-resistant gram-negative infections
11 November 2019 - FDA QIDP and fast track designations signify significant milestones in Allergan commitment to addressing unmet medical needs ...
Posted by Michael Wonder on 05 Nov 2019
RedHill Biopharma announces FDA approval of Talicia for treatment of H. pylori in adults
4 November 2019 - RedHill plans to launch Talicia in the U.S. in Q1/2020 for the treatment of H. pylori infection ...
Posted by Michael Wonder on 28 Oct 2019
Heron Therapeutics announces FDA acceptance of new drug application resubmission for HTX-011 for management of post-operative pain
28 October 2019 - FDA sets prescription drug user fee act goal date of 26 March 2020. ...
Posted by Michael Wonder on 23 Oct 2019
Vertex prices cystic fibrosis combo treatment at $311,000-per-year
22 October 2019 - Vertex Pharmaceuticals has priced its three-drug combination for cystic fibrosis (CF) at $311,503 per year, after winning ...
Posted by Michael Wonder on 16 Oct 2019
ViiV Healthcare submits supplemental new drug application to US FDA for use of Dovato in virologically suppressed adults with HIV-1
16 October 2019 - ViiV Healthcare announced the submission of a supplemental New Drug Application to the US FDA for ...
Posted by Michael Wonder on 08 Oct 2019
HIV prevention drugs will be available without a prescription in California
7 October 2019 - California will expand access to HIV prevention drugs by allowing pharmacies to offer the medications without ...
Posted by Michael Wonder on 03 Oct 2019
FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic
3 October 2019 - The U.S. FDA today approved Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) in at-risk ...