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The Latest Breaking News from FDA

DEA Stonewalling MMJ's MS & Huntington's Disease Clinical Trials For 3 Years

MMJ companies are building a center of marijuana excellence in Rhode Island and has filed for FDA sanctioned clinical trials in multiple sclerosis and Huntington's disease. MMJ was awarded the much coveted orphan drug designation from the FDA for its planned Huntington's disease trials, and has also received a D

Benzinga

GSK Shows Positive Pivotal Phase III Data For Its RSV Vaccine Candidate

GSK plc (NYSE:GSK) intends to engage with regulators immediately after reporting positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 phase III trial, it anticipates regulatory submissions in the second half of 2022. AReSVi 006 is a phase III trial investigating GSK’s respiratory syncytial virus (RSV) vaccine candidate…

Benzinga

69 Biggest Movers From Yesterday

Gainers Powerbridge Technologies Co., Ltd. (NASDAQ: PBTS) shares climbed 189.9% to close at $1.12 on Thursday.

Benzinga

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Mayo Clinic Minute: What to expect with COVID-19 vaccinations for youngest kids

The Food and Drug Administration (FDA) could grant emergency use authorization of a COVID-19 vaccination for the youngest kids later this month. Pfizer asked the agency to review data and authorize its COVID-19 vaccine for children ages 6 months to 5 years.

Tribune News Service

Bluebird Bio Secures FDA Advisory Committee's Endorsement For Neurodegenerative Disease Drug

The U.S.

Benzinga

Kingdom decriminalises ganja

More than 150,000 people registered to cultivate cannabis with the Food and Drug Administration (FDA) on Thursday as the decriminalisation of the plant took effect.

Bangkok Post

FDA imposes 'Class 1' recall status on Medtronic's latest HeartWare defect

Federal regulators this week upgraded the recall of Medtronic's HeartWare Ventricular Assist Device to a Class 1 recall, its most serious classification.

Tribune News Service

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Why Moderna Stock Is Moving Lower Today

Moderna Inc (NASDAQ: MRNA) shares are trading lower Thursday as vaccine stocks fall in sympathy with Novavax Inc (NASDAQ: NVAX) following reports the FDA's decision on the company's COVID-19 vacci

Benzinga

Thailand Decriminalizes Marijuana Amid Warnings Not To Get Carried Away And Become 'Non-Productive'

Thailand became the first South-East Asian country to decriminalize marijuana on Thursday, reported CNN Travel.

Benzinga

More peanut butter products have been recalled after Jif pulled some of its jars

There are more than a dozen recalls related to last month's Jif peanut butter recall. Products from F&S Produce and Taharka Brothers have been added to the list.

WEKU

North Carolina House Says Yes To Bill Allowing FDA-Approved THC Drugs, Will This Kill Full Medical Marijuana Legalization?

The North Carolina House passed Senate Bill 448, legalizing FDA-approved THC medications in a 92-9 vote, reported The Carolina Journal.

Benzinga

Why Bluejay Diagnostics Shares Are Surging Higher Today

Shares of small-cap penny stock Bluejay Diagnostics, Inc. (NASDAQ: BJDX) are trading higher after the company announced that the FDA has agreed to consider its plan to pursue a De Novo submission for the Symphony IL-6 Test.

Benzinga

Misinformation clouds America’s most popular emergency contraception

A brand of specialty mozzarella cheeses. A collection of natural-gas storage terminals. And America’s top-selling emergency contraception.

Tribune News Service

TLSA: Clinical Improvements for 2nd SPMS Patient

By John Vandermosten, CFA NASDAQ:TLSA Clinical Results for Second SPMS Patient

Benzinga

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Benzinga

Why Novavax Stock Is Falling Today

Novavax Inc (NASDAQ: NVAX) shares are trading lower Thursday following reports that the U.S. Food and Drug Administration's decision on the company's COVID-19 vaccine could be delayed to review manufacturing changes.

Benzinga

Eledon Pharmaceuticals' Stock Gains As FDA Grants Orphan Drug Designation

Eledon Pharmaceuticals (NASDAQ: ELDN) received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its drug candidate Tegoprubart for the Prevention of Allograft Rejection in Pancreatic Islet Cell Transplantation.

Tribune News Service

Kansas man says he got lung cancer from CPAP sleep apnea machine. He’s suing

KANSAS CITY, Mo. — A Johnson County, Kansas, man blames his sleep apnea machine for giving him lung cancer and is suing the manufacturer, which last year recalled the machine and several other breathing-aid devices.

Benzinga

US Schedules Covid-19 Vaccines For Children Below Five Years

The U.S. government is preparing to launch vaccines for children below five in conjunction with educational and outreach efforts, pending approval by federal regulators, the Wall Street Journal reports. The government looks to provide ten million initial doses as the virus spreads nationwide, leaving the parents anxious. The vaccinations could begin…

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The Independent UK

Officials: Millions of COVID-19 shots ordered for youngest

White House officials say orders have been coming in for COVID-19 vaccine doses for small children

Bangkok Post

Over 100,000 people register to grow cannabis

More than 100,000 people registered to cultivate cannabis via the application and website of the Food and Drug Administration on Thursday morning as the legalisation of cannabis and hemp took effect.

The Independent UK

New vaccine may be option for troops with religious concerns

A COVID-19 vaccine that could soon win federal approval may offer a boost for the U.S. military: an opportunity to get shots into some of the thousands of service members who have refused the other coronavirus vaccines for religious reasons

Benzinga

Vertex Pharma Gains FDA Breakthrough Therapy Designation For Kidney Disease Drug

Vertex Pharmaceuticals (NASDAQ: VRTX) received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its drug candidate inaxaplin (VX-147) for the treatment of patients with APOL1-mediated focal segmental glomerulosclerosis (FSGS).

Benzinga

BioCryst Gets FDA Fast Track Designation For Bone Formation Disorder Candidate

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BioCryst Pharmaceuticals's (NASDAQ: BCRX) lead drug candidate BCX9250 for the prevention of heterotopic ossification (HO) in patients with fibrodysplasia ossificans progressiva (FOP).

Benzinga

Why Alpha Tau Medical Shares Are Rising Today

Alpha Tau Medical Ltd. (NASDAQ: DRTS) shares are trading higher after the company announced FDA approval of its IDE application to initiate its multi-center pivotal study for the treatment of recurrent cutaneous Squamous Cell Carcinoma using the Alpha DaRT.

Benzinga

Why Aldeyra Therapeutics' Shares Are Soaring Today?

Aldeyra Therapeutics Inc's (NASDAQ:ALDX) Phase 3 TRANQUILITY-2 trial of reproxalap for dry eye disease has achieved the primary endpoint. Reproxalap was statistically superior to the vehicle for each of the two prespecified primary endpoints, Schirmer test and ≥10 mm Schirmer test responder proportions after a single day of dosing. The Schirmer test,…

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