FDA Issues CRL to SNY's Regulatory Filing for Multiple Sclerosis Drug
Sanofi receives an FDA CRL for tolebrutinib in nrSPMS after multiple review extensions. The EC clears Wayrilz for treating immune thrombocytopenia.
Zacks·1d ago
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AGIO's Mitapivat Gets FDA Nod for Thalassemia Indication with REMS in Label
Agios Pharmaceuticals wins FDA approval for Aqvesme in alpha- and beta-thalassemia, making mitapivat the only approved option, despite a new REMS.
Zacks·1d ago
Sanofi to Buy Dynavax for $2.2B to Boost Adult Vaccine Franchise
SNY's $2.2 billion deal for Dynavax adds Heplisav-B, a shingles candidate, and other vaccine programs, strengthening its adult vaccine franchise and pipeline.
Zacks·2d ago
What Makes Castle Biosciences (CSTL) a Good Fit for 'Trend Investing'
Castle Biosciences (CSTL) could be a great choice for investors looking to make a profit from fundamentally strong stocks that are currently on the move. It is one of the several stocks that made it through our "Recent Price Strength" screen.
Zacks·2d ago
GILD Exercises Option to License Assembly Bio's Herpes Programs
Gilead exercises its option to license ASMB's HSV programs for developing long-acting candidates, ABI-1179 & ABI-5366, for recurrent genital herpes.
Zacks·2d ago
CRSP Stock Rises on Encouraging Early Data From Zugo-Cel Studies
CRISPR Therapeutics shares jump after early zugo-cel study data show sustained B-cell depletion and early efficacy across autoimmune and cancer studies.
Zacks·3d ago
JNJ's Tremfya Gets EU Approval for Pediatric Plaque Psoriasis
Johnson & Johnson wins EU approval for Tremfya in pediatric plaque psoriasis, making it the first IL-23 inhibitor cleared for any pediatric condition.
Zacks·3d ago
AZN, Daiichi's Enhertu Gets FDA Nod for First-Line Breast Cancer (Revised)
AstraZeneca's Enhertu wins FDA nod as a first-line treatment for HER2-positive metastatic breast cancer.
Zacks·3d ago
AZN, Daiichi's Enhertu Gets Breakthrough Tag for Expanded Cancer Use
AstraZeneca's Enhertu wins FDA Breakthrough tag for expanded use in breast cancer, while a late-stage study on ceralasertib + Imfinzi in lung cancer misses its goal.
Zacks·4d ago
Castle Biosciences (NASDAQ:CSTL) Hits New 12-Month High After Analyst Upgrade
Castle Biosciences (NASDAQ:CSTL) Sets New 1-Year High After Analyst Upgrade...