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Zacks News
Gilead Sciences (GILD) Gains As Market Dips: What You Should Know
by Zacks Equity Research
Gilead Sciences (GILD) closed the most recent trading day at $76.29, moving +0.9% from the previous trading session.
Gilead Sciences (GILD) Gains As Market Dips: What You Should Know
by Zacks Equity Research
Gilead Sciences (GILD) closed the most recent trading day at $76.29, moving +0.9% from the previous trading session.
Affimed (AFMD) Surges on Collaboration Contract with Roche (revised)
by Zacks Equity Research
Affimed (AFMD) inks a strategic collaboration deal with Roche to develop a host of immunotherapies for treating different types of cancer.
Bausch (BHC) Resubmits NDA for Duobrii for Plaque Psoriasis
by Zacks Equity Research
Bausch Health Companies Inc. (BHC) resubmits its NDA for plaque psoriasis drug, Duobrii to the FDA and the agency has set a PDUFA action date of Feb 15, 2019.
Ultragenyx to File NDA for LC-FAOD Candidate on Existing Data
by Zacks Equity Research
Ultragenyx (RARE) plans to submit an NDA for UX007 for the treatment of LC-FAOD on existing data, as per agreement with the FDA.
Amgen's Leukemia Drug Blincyto Gets EU Nod for Pediatric Use
by Zacks Equity Research
Amgen's (AMGN) leukemia drug, Blincyto gets approval in EU for use in pediatric patients aged one year or older.
Affimed (AFMD) Surges On Collaboration Contract With Roche
by Zacks Equity Research
Affimed (AFMD) inks a strategic collaboration deal with Roche to develop a host of immunotherapies for treating different types of cancer.
Biotech Stock Roundup: GILD Gets EC Nod for Yescarta, AMGN Submits Kyprolis sNDA
by Zacks Equity Research
Regulatory and pipeline updates comprise some of the key developments in the biotech sector this week. These include Gilead's Yescarta approval in Europe.
Ultragenyx's Rare Disease Drug Mepsevii Gets EU Approval
by Zacks Equity Research
Ultragenyx's (RARE) Mepsevii gets European approval for the treatment of Mucopolysaccharidosis VII.
Bayer's Blood Thinner Xarelto Fails in Line Extension Studies
by Zacks Equity Research
Bayer (BAYRY) and partner Johnson & Johnson's drug, Xarelto shows no significant difference when compared with placebo in two late-stage phase III studies.
Amgen Files for Once-Weekly Regimen for Myeloma Drug Kyprolis
by Zacks Equity Research
Amgen (AMGN) submits a supplemental new drug application to the FDA, seeking an approval for once-weekly dosage of its multiple myeloma drug, Kyprolis, combined with dexamethasone (Kd).
Gilead's CAR-T Therapy Yescarta Gets Approval in Europe
by Zacks Equity Research
Gilead's (GILD) CAR-T therapy, Yescarta gets approval in Europe for adult patients suffering from relapsed or refractory DLBCL and PMBCL, after two or more lines of systemic therapy.
Bausch (BHC) Gets FDA Approval for Altreno for Acne Vulgaris
by Zacks.com
Bausch (BHC) advances its dermatology portfolio with the FDA approval of Altreno for acne vulgaris.
Novartis' CAR-T Therapy Kymriah Gets Approval in Europe
by Zacks Equity Research
Novartis (NVS) gets EC approval for CAR-T therapy, Kymriah, for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia.
Novo Nordisk's Ozempic Lowers Risk of Cardiovascular Events
by Zacks Equity Research
Novo Nordisk (NVO) announces post hoc results from SUSTAIN 6 study demonstrating that Ozempic consistently reduces the risk of major cardiovascular (CV) events across type II diabetes population.
Why Is Gilead (GILD) Down 6.2% Since Last Earnings Report?
by Zacks Equity Research
Gilead (GILD) reported earnings 30 days ago. What's next for the company? We take a look at earnings estimates for some clues.
Shire's Takhzyro Gets FDA Nod for Hereditary Angioedema
by Zacks Equity Research
Shire???s (SHPG) Takhzyro gets approval from the FDA for the treatment of hereditary angioedema in patients 12 years of age and older. It is the first-of-its-kind mAb preventive treatment for the same.
Roche (RHHBY) Gets FDA Approval for Cobas EFGR Mutation Test
by Zacks Equity Research
Roche's (RHHBY) cobas EGFR Mutation Test v2 gets FDA nod as a companion diagnostic test with IRESSA.
AbbVie Posts Positive Data on Elagolix for Uterine Fibroids
by Zacks Equity Research
AbbVie (ABBV) reports positive top-line results from a phase III extension trial on its investigational candidate Elagolix for treating uterine fibroids in women.
Exact Sciences Inks Cologuard Co-Promotion Deal With Pfizer
by Zacks Equity Research
Exact Sciences (EXAS) reaches a co-promotion agreement with Pfizer to commercialize its non-invasive screening test for colorectal cancer, Cologuard. The stock rallies following this news.
4 Biotech Stocks Investors Can Bet on Post Solid Q2 Earnings
by Ekta Bagri
The biotech sector is expected to do well in the second half of 2018. Here we list four top biotech companies, which investors can add to their portfolio.
Mallinckrodt's Stannsoporfin Gets Complete Response Letter
by Zacks Equity Research
Mallinckrodt's (MNK) pipeline candidate, Stannsoporfin gets a Complete Response Letter from the FDA.
Don't Worry About An Inverted Yield Curve...YET
by John Blank
The U.S. economy should remain out of recession until 2020.
Alnylam Completes Enrollment in Phase III Givosiran Study
by Zacks Equity Research
Alnylam Pharmaceuticals (ALNY) completes enrollment in the phase III ENVISION study ahead of schedule of its pipeline candidate, givosiran.
Pacira (PCRX) Rides High on Robust Exparel Performance
by Zacks Equity Research
Pacira (PCRX) focuses on improving sales of its flagship product Exparel. The drug's label expansion programs also look encouraging.