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The U.S. Food and Drug Administration notified Avadel Pharmaceuticals plc (AVDL) that the review of the New Drug Application (NDA) for FT218 is still ongoing, and action will likely not be taken in October. AVDL closed Friday regular trading at $9.99 up $0.65 or 6.96%. But in the after-hours trade,...

Amazon.com (AMZN) said that the United States Attorney's Office for the Western District of Michigan charged four individuals in a more than 30 count indictment for their role in defrauding Amazon's textbook rental program. The charges include mail fraud, wire fraud, and making false statements. Amazon...

Charles Schwab Corp. (SCHW) reported that its third-quarter net income available to common stockholders climbed to $1.41 billion or $0.74 per share from $615 million or $0.48 per share last year. Adjusted net income available to common stockholders was $1.60 billion or $0.84 per share compared to...

AbbVie (ABBV) said that the European Medicines Agency's or EMA Committee for Medicinal Products for Human Use or CHMP recommended the approval of Risankizumab (SKYRIZI) alone or in combination with methotrexate (MTX), for the treatment of active psoriatic arthritis in adults who have had an inadequate...

LumiraDx (LMDX) said that it has submitted the LumiraDx SARS-CoV-2 & Flu A/B Test to the U.S. Food and Drug Administration for Emergency Use Authorization or EUA. The microfluidic immunofluorescence assay can quickly verify infection for patients suspected of flu and/or COVID-19 to aid diagnosis...

Prologis, Inc. (PLD) said its third quarter results were underpinned by record increases in market rents and valuations. Looking forward, the company said its earnings potential is unrivaled, and increased fiscal 2021 earnings guidance. For fiscal 2021, the company now expects net earnings per share...

Gilead Sciences Inc. (GILD) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA adopted a positive opinion for sacituzumab govitecan as monotherapy indicated for adult patients with unresectable or metastatic triple-negative breast cancer or TNBC...

The European Medicines Agency's or EMA Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion recommending the 100 mg and 200 mg doses of abrocitinib, an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for marketing authorization to treat moderate to severe atopic dermatitis...

Merck & Co. Inc. (MRK) and Eisai said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has adopted positive opinions recommending approval of the combination of Keytruda, Merck's anti-PD-1 therapy, plus Lenvima, the orally available multiple receptor tyrosine...

ADTRAN, Inc. (ADTN) on Friday said it expects revenue of $138 million in the third quarter. This compares with the average estimate of analysts polled by Thomson Reuters of $148.95 million. The company sees gross margin of 34.5% and operating loss of $10.2 million for the third quarter. On an adjusted...

Nanocyn Disinfectant & Sanitizer has been approved by the Australian Therapeutic Goods Administration with a 15 second SARS-CoV-2 (COVID-19) kill time, Sonoma Pharmaceuticals Inc. (SNOA) and its partner, the MicroSafe Group said in a statement. In Friday pre-market trade, SNOA was trading at $7.21...

Sensient Technologies Corporation (SXT) reported third quarter adjusted operating income of $47.8 million, an increase of 15.0% from prior year. Reported Consolidated revenue growth was 6.4%, for the quarter, while adjusted consolidated local currency revenue growth was 13.0%. Adjusted earnings per...

Portland General Electric (POR) said it plans to increase the amount of clean energy it serves to customers and meet its target of reducing greenhouse gas emissions from power served to customers by at least 80% by 2030, 90% by 2035 and zero emissions by 2040. The company on Friday initiated its request...

Knorr-Bremse Aktiengesellschaft (KNRRY.PK, KNBHF.PK) said Peter Laier, member of the Executive Board and globally responsible for the Commercial Vehicle Systems division, will resign from the Executive Board, effective December 31, 2021. The division will be managed on an interim basis by the CEO Jan...

AstraZeneca (AZN, AZN.L) said results from the HIMALAYA Phase III trial showed a single, high priming dose of tremelimumab added to Imfinzi or durvalumab demonstrated a statistically significant and clinically meaningful overall survival benefit versus sorafenib as a 1st-line treatment for patients with...

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