FDA Archives - Page 70 of 220

1 minute read

FDA Signals Support For Pfizer’s Maternal RSV Shot Ahead Of Adcomm, Pfizer Raises $31B In Debt To Fund Seagen Deal

May 17, 8:17 AM

Pfizer Inc (NYSE: PFE) plans to raise $31 billion from a debt offering to finance its proposed acquisition of Seagen Inc (NASDAQ: SGEN)

AMGN

1 minute read

Back Off, Chronic Pain! FDA Nods for Abbott’s Spinal Cord Stimulation Devices

By Vandana Singh

May 16, 2:22 PM

The FDA approved Abbott Laboratories (NYSE: ABT) spinal cord stimulation (SCS) devices for chronic back pain in people who have not had or are not eligible to receive back surgery, known as

ABT

1 minute read

Why Are Phio Pharmaceuticals Shares Trading Higher Today

By Vandana Singh

May 16, 12:14 PM

Phio Pharmaceuticals Corp (NASDAQ: PHIO) shares are gaining after the FDA cleared its Investigational New Drug (IND) application to proceed with a clinical trial of Phio's

PHIO

3 minute read

Abbott Receives FDA Approval For Its Spinal Cord Stimulation Systems To Treat Chronic Back Pain In People Who Have Limited Surgical Options

By Happy Mohamed

May 16, 9:01 AM

FDA approval was backed by Abbott's DISTINCT study, the largest randomized controlled trial for spinal cord stimulation (SCS) in people with chronic back pain when surgery is not an option Results for the first

ABT

1 minute read

Philips Says Test Results Show Recalled Sleep Devices Unlikely To Cause Harm

By Lekha Gupta

May 16, 7:36 AM

Koninklijke Philips NV (NYSE:PHG) released an update on a comprehensive test and research program related to the recalled respiratory devices. …

PHG

2 minute read

Health Canada Accepts New Drug Submission For Lecanemab As Treatment For Early Alzheimer’s Disease

By Happy Mohamed

May 16, 1:28 AM

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (NASDAQ:BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, ", , Biogen", , ))))

BIIB

1 minute read

FDA
News

Immutep Receives Positive Feedback from FDA on Late-Stage Clinical Development of Eftilagimod Alpha in Non-Small Cell Lung Cancer

By Charles Gross

May 15, 7:42 PM

Immutep Limited ((ASX: IMM, NASDAQ:IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces

IMMP

1 minute read

Caldolor: The Only Non-Opioid Injectable Pain Reliever Approved for Use in Infants, Says FDA

By Vandana Singh

May 15, 11:42 AM

The FDA has approved expanded labeling for Cumberland Pharmaceuticals Inc's (NASDAQ: CPIX) Caldolor, an intravenously delivered formulation of ibuprofen,

CPIX

5 minute read

Google Launches Tools To Detect Fake Images, Apple May Encounter Delays In iPhone 15 Production, Shake Shack Sees Activist Investor Proxy Fight: Today’s Top Stories

By Vandana Singh

May 15, 9:47 AM

Bloomberg

AAPL

1 minute read

Why Sarepta Therapeutics Stock Is Soaring Today

By Adam Eckert

May 15, 8:54 AM

Sarepta Therapeutics Inc (NASDAQ: SRPT) shares are trading higher Monday after the company announced the FDA voted in favor of its gene therapy to treat Duchenne muscular dystrophy late Friday. Multiple analysts raised price targets

SRPT