FDA Accepts Merck's (MRK) BLA for 21-Valent Pneumococcal Jab
https://www.zacks.com/stock/news/2200645/fda-accepts-merck-s-mrk-bla-for-21-valent-pneumococcal-jab?cid=CS-ZC-FT-analyst_blog|company_news_-_medical_sector-2200645
Dec 20, 2023 - The FDA grants priority review to Merck's (MRK) filing seeking approval for its 21-valent pneumococcal conjugate vaccine in adults. A final decision is expected in June 2024.
0
Jazz Pharmaceuticals' (JAZZ) PTSD Drug Misses Study Goals
https://www.zacks.com/stock/news/2201716/jazz-pharmaceuticals-jazz-ptsd-drug-misses-study-goals?cid=CS-ZC-FT-analyst_blog|company_news_-_medical_sector-2201716
Dec 22, 2023 - After a mid-stage study fails to show any improvement in its primary or secondary endpoints, Jazz (JAZZ) plans to scrap the development of its PTSD drug.
0
Sarepta (SRPT) Seeks Label Expansion for DMD Gene Therapy
https://www.zacks.com/stock/news/2202279/sarepta-srpt-seeks-label-expansion-for-dmd-gene-therapy?cid=CS-ZC-FT-analyst_blog|company_news_-_medical_sector-2202279
Dec 26, 2023 - Sarepta (SRPT) files a supplement with the FDA seeking to expand its recently-approved gene therapy Elevidys' label to treat all DMD patients, regardless of age and ambulatory status.
0
FDA Rejects Amgen's (AMGN) NDA Seeking Full Nod for Lumakras
https://www.zacks.com/stock/news/2202718/fda-rejects-amgen-s-amgn-nda-seeking-full-nod-for-lumakras?cid=CS-ZC-FT-analyst_blog|company_news_-_medical_sector-2202718
Dec 27, 2023 - Per the FDA, Amgen (AMGN) will need to complete an additional confirmatory study on Lumakras in certain lung cancer patients before February 2028 to secure full approval.
0
Novo Nordisk (NVO) Gets Positive CHMP Opinion for Insulin Icodec
https://www.zacks.com/stock/news/2245039/novo-nordisk-nvo-gets-positive-chmp-opinion-for-insulin-icodec?cid=CS-ZC-FT-analyst_blog|company_news_-_medical_sector-2245039
Mar 22, 2024 - Novo Nordisk (NVO) receives a positive opinion from the CHMP for once-weekly basal insulin icodec for the treatment of diabetes in adults.
0
Bristol Myers (BMY) Reports Positive Colorectal Cancer Study Data
https://www.zacks.com/stock/news/2252898/bristol-myers-bmy-reports-positive-colorectal-cancer-study-data?cid=CS-ZC-FT-analyst_blog|company_news_-_medical_sector-2252898
Apr 09, 2024 - Bristol Myers' (BMY) Krazati, in combination with cetuximab, demonstrates clinically meaningful activity as a targeted treatment option for patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer.
0
Pages: 12
<Page 2