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RSS FeedPosted by Michael Wonder on 22 Aug 2018
FDA approves first drug for neurotrophic keratitis, a rare eye disease
22 August 2018 - The U.S. FDA today approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a ...
Posted by Michael Wonder on 22 Aug 2018
Mallinckrodt confirms receipt of stannsoporfin complete response letter
22 August 2018 - Mallinckrodt confirmed today that it has received a complete response letter from the U.S. FDA related ...
Posted by Michael Wonder on 22 Aug 2018
Allergan receives complete response letter from the U.S. FDA for ulipristal acetate new drug application
21 August 2018 - Allergan today announced it received a complete response letter from the U.S. FDA in response to the ...
Posted by Michael Wonder on 21 Aug 2018
United States FDA approves Teva's generic epinephrine injection auto-injector
16 August 2018 - Teva is pleased with the US FDA's approval of its generic versions of EpiPen and EpiPen ...
Posted by Michael Wonder on 21 Aug 2018
FDA approves expanded label for Merck’s Keytruda (pembrolizumab) in combination with pemetrexed (Alimta) and platinum chemotherapy for first-line treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumour aberrations
20 August 2018 - Approval based on results of KEYNOTE-189, where Keytruda in combination with pemetrexed and platinum chemotherapy reduced the ...
Posted by Michael Wonder on 17 Aug 2018
FDA approves Eylea (aflibercept) injection sBLA in wet age-related macular degeneration
17 August 2018 - Regeneron Pharmaceuticals today announced that the U.S. FDA has approved a supplemental biologics license application for ...
Posted by Michael Wonder on 17 Aug 2018
U.S. FDA approves Opdivo (nivolumab) as the first new medication in nearly 20 years for certain patients with previously treated small cell lung cancer
17 August 2018 - Opdivo is now the first immuno-oncology treatment approved for small cell lung cancer patients who received platinum-based ...
Posted by Michael Wonder on 17 Aug 2018
FDA approves generic EpiPen that may be cheaper
16 August 2018 - The FDA on Thursday approved the first generic version of EpiPen, providing new competition that could ...
Posted by Michael Wonder on 17 Aug 2018
Eisai and Merck announce FDA approval of Lenvima (lenvatinib) capsules for first-line treatment of unresectable hepatocellular carcinoma
16 August 2018 - Approval was based on REFLECT, the first-ever positive Phase 3 trial against an active comparator in previously ...
Posted by Michael Wonder on 17 Aug 2018
Sun Pharma announces U.S. FDA approval of Cequa to treat dry eye disease
16 August 2018 - Cequa (cyclosporine ophthalmic solution) 0.09% for topical ophthalmic use is the first and only dry eye ...
Posted by Michael Wonder on 16 Aug 2018
FDA approves first generic version of EpiPen
16 August 2018 - The U.S. FDA today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for ...
Posted by Michael Wonder on 16 Aug 2018
FDA approves Kalydeco (ivacaftor) as first and only medicine to treat the underlying cause of CF in children ages 12 to <24 months with certain mutations in the CFTR gene
15 August 2018 - Data from Phase 3 ARRIVAL study support treatment with Kalydeco in children ages 12 to <24 months. ...
Posted by Michael Wonder on 13 Aug 2018
Regeneron provides regulatory update on Eylea (aflibercept) injection sBLA in wet age-related macular degeneration
13 August 2018 - Regeneron Pharmaceuticals today announced that due to ongoing labelling discussions the U.S. FDA has issued a ...
Posted by Michael Wonder on 12 Aug 2018
FDA approves new vaginal ring for one year of birth control
10 August 2018 - The U.S. FDA today approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), which is a combined ...
Posted by Michael Wonder on 11 Aug 2018
FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease
10 August 2018 - The U.S. FDA today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused ...