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416 Result: FDA

Positive FDA Update Boosts Molecular Templates; Duluth Holdings and Caleres Beat Estimates

June 01st, 2023

Molecular Templates, Inc. (Nasdaq: MTEM), a biopharmaceutical company, received positive news from the U.S. Food and Drug Administration (FDA) regarding its MT-0169 trial.  The FDA has lifted the partial clinical hold on patient enrollment, all. Read more

FDA Conducts Retailer Inspection Blitz, Cracks Down on Illegal Sales of Popular Disposable E-cigarettes

May 31st, 2023

Washington D.C. / CRWE PRESS RELEASE / May 31, 2023 -  Today, the U.S. Food and Drug Administration issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized tobacco products. The unauth. Read more

Advance Auto Parts Q1 Results Fall Short of Consensus, Lowers Outlook; iRhythm Technologies Reveals FDA Warning Letter

May 31st, 2023

The first quarter of 2023 proved to be challenging for Advance Auto Parts, Inc. (NYSE: AAP), as the company reported diluted earnings per share (EPS) of $0.72, falling short of the consensus estimate of $2.57.  Tom Greco, the president and ch. Read more

FDA Notifies PepGen, LL Flooring Becomes Takeover Target, JOYY Beats Estimates: Key Updates and Market Movements

May 31st, 2023

PepGen Inc. (Nasdaq: PEPG), a biotechnology company specializing in genetic therapies, received a clinical hold notice from the U.S. Food and Drug Administration (FDA) for their Investigational New Drug Application (IND) related to a Phase 1 study of. Read more

FDA's Decision Boost Stock Prices for Lexicon Pharmaceuticals and Iovance Biotherapeutics

May 27th, 2023

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced that the FDA has granted approval for their once-daily oral tablet, INPEFA (sotagliflozin).  This medication aims to reduce the risk of cardiovascular death, hospitalization for heart fai. Read more

FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults

May 25th, 2023

Silver Spring, MD / CRWE PRESS RELEASE / May 25, 2023  -  Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mil. Read more

GoHealth Soars on Acquisition Proposal, Intercept Pharma Faces FDA Committee Setback for OCA in NASH Treatment

May 20th, 2023

GoHealth, Inc. (Nasdaq: GOCO) has officially confirmed that it has received a proposal from its two largest shareholders, Centerbridge Partners and NVX Holdings. The proposal entails acquiring all of the outstanding Class A Common Stock and LLC Inter. Read more

RBC Bearings Beats Expectations, Hologic Receives FDA Clearance, Cantor Fitzgerald Bullish on Bitfarms

May 19th, 2023

RBC Bearings Incorporated (NYSE: RBC) has released its fourth-quarter fiscal 2023 earnings report, surpassing consensus expectations. The company reported an EPS of $2.13, exceeding the consensus estimate of $1.99. In pre-market, $RBC is currently. Read more

Deere & Company Surpasses Q2 Expectations, Foot Locker Falls Short, and Intercept Pharmaceuticals Stock Halted Amid FDA Review

May 19th, 2023

Deere & Company (NYSE: DE) has released its second-quarter fiscal 2023 earnings per share (EPS) report, surpassing consensus expectations. The company reported an EPS of $9.65, exceeding the consensus estimate of $8.59. John C. May, the chairman a. Read more

Ross Stores Exceeds Q1 Expectations, Pfizer's RSV Vaccine Candidate Gains FDA Committee Support, Lucy Scientific Partners with TheraPsil for Psilocybin Access

May 18th, 2023

Ross Stores, Inc. (Nasdaq: ROST) has reported first-quarter fiscal 2023 earnings per share (EPS) of $1.09, surpassing the consensus estimate of $1.06. However, in after-hours trading, $ROST is experiencing a slight decline, currently trading at $105.. Read more

National Western Life Group Exploring Strategic Alternatives, Bausch Health Surges on U.S. District Court's Decision, Kura Oncology Initiated with a Buy

May 17th, 2023

National Western Life Group, Inc. (Nasdaq: NWLI) has announced its intention to explore strategic alternatives with the aim of maximizing value for its stockholders. At this stage, no specific decision has been made regarding a sale, merger, or other. Read more

FTC Sues to Block Biopharmaceutical Giant Amgen from Acquisition That Would Entrench Monopoly Drugs Used to Treat Two Serious Illnesses

May 16th, 2023

The $27.8 billion acquisition of Horizon Therapeutics plc would enable Amgen Inc. to stifle competition for thyroid eye disease and chronic refractory gout treatments, the agency says LAS VEGAS, NV / CRWE PRESS RELEASE / May 16, 2023 -  The F. Read more

Phio Pharmaceuticals' IND Cleared by FDA, YS Biopharma Advances in Rabies Vaccine Trial, Gilead Sciences Upgraded

May 16th, 2023

Phio Pharmaceuticals Corp. (Nasdaq: PHIO) has announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for its lead product candidate, PH-762. This will allow Phio to proceed . Read more

Getaround's Acquisition and ARS Pharmaceuticals' Positive FDA Committee Vote Drive Surge in Pre-Market Trading

May 12th, 2023

In exciting news, Getaround, Inc. (NYSE: GETR) has announced its acquisition of the majority of assets from HyreCar, a leading gig carsharing marketplace. The purchase price for this transaction amounts to an impressive $9.45 million. By integrating . Read more

Sunshine Biopharma Reports Exponential Q1 Revenue Growth; Jaguar Health's Canalevia-CA1 Now Available on Chewy; Albemarle Upgraded: Market Highlights

May 11th, 2023

Sunshine Biopharma, Inc. (Nasdaq: SBFM) has released its 2023 First Quarter Results, showcasing impressive growth. The company reported gross revenues of $4,894,053 as of March 31, 2023, marking an exceptional increase of more than 2,100% compared to. Read more

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