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The Latest Breaking News from FDA

Canada Approves Amylyx's ALS Drug; FDA To Consider Approval In September

The Canadian government has given its approval to AMX0035, a new drug from Cambridge, Massachusetts-based Amylyx Pharmaceuticals Inc.

Benzinga

Novavax' Sees Conditional Approval Of COVID-19 Vaccine Booster In Australia As US FDA Delays Its Decision

The Australian regulatory authority has conditionally approved Novavax Inc's (NASDAQ:NVAX) Nuvaxovid (NVX-CoV2373) COVID-19 vaccine as a booster in individuals aged 18 and over. The provisional registration was based on data from Novavax's Phase 2 trial conducted in Australia, wherein a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after…

Benzinga

Why Lensar Shares Are Trading Higher Today

The FDA granted 510(k) clearance to Lensar Inc's (NASDAQ:LNSR) next-generation ALLY Adaptive Cataract Treatment System (ALLY System). ALLY is the first FDA-cleared platform to enable cataract surgeons to complete the femtosecond-laser-assisted cataract surgery (FLACS) procedure seamlessly in a single, sterile environment. The company plans to deliver the first ALLY Systems to surgeons in Q3…

Benzinga

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What's Next For NRx Pharma As FDA Denies Breakthrough Therapy Tag For COVID-19 Therapy

The FDA has denied NRx Pharmaceuticals Inc's (NASDAQ:NRXP) Breakthrough Therapy designation (BTD) request for Zyesami (aviptadil). The request for BTD was submitted based on a post-hoc subgroup analysis of patients who, in addition to aviptadil or placebo, were also treated with Gilead Sciences Inc's (NASDAQ: GILD) remdesivir and whose respiratory failure due to critical COVID-19 continued…

Benzinga

The US baby formula shortage isn’t bad luck. It was completely preventable

Shortages of vital, life-preserving goods are routine in America – and they’re the product of bad policy

The Guardian - US

5 Biotech Stocks To Watch During The Week Of June 13

Biotech stocks continued to be under pressure in the past week amid broader market weakness, precipitated by economic worries. Company-specific developments also triggered downward moves. Here's a compilation of five stocks that should be on your radar in the week of June 13: 1. Novavax

Benzinga

The youngest Americans may finally get their COVID shots

Regulators will evaluate both Pfizer-BioNTech and Moderna shots this week.

Axios

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Many baby formula plants weren't inspected because of COVID

U.S. regulators have historically inspected baby formula plants at least once a year, but they did not inspect any of the three biggest manufacturers in 2020

The Independent UK

Pfizer COVID shot works, safe for youngest kids, FDA says

U.S. Food and Drug Administration staff said that Pfizer Inc.’s COVID-19 shot was effective for kids ages 4 and under with no new safety concerns, in a report released ahead of a key meeting of FDA advisers later this week.

Tribune News Service

US: Pfizer COVID-19 appears effective for kids under 5

A review by federal health officials says that Pfizer's COVID-19 vaccine appears safe and effective for children under 5, the only group not currently eligible for vaccination

The Independent UK

Why the world's still waiting for a dementia cure, and what we can do in the meantime

Many researchers agree that Alzheimer's disease actually starts decades before thinking and memory start to decline. What can we do about it?

ABC News

The hard road for the Novavax vaccine

Novavax now in financial trouble after missing peak vaccinations

Salon

Q&A: California lawmaker takes on insurance companies and gets personal about his health

SACRAMENTO, Calif. — California state Sen. Scott Wiener made a startling revelation at a spring legislative committee hearing: “I was in the hospital. I experienced the most intense abdominal pain that I could even imagine.”

Tribune News Service

Moderna shot 'works in kids 6 months and up'

Moderna Inc's Covid-19 vaccine is effective in children and adolescents, with mostly mild to moderate side effects, the United States Food and Drug Administration staff said.

Bangkok Post

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Tribune News Service

Moderna data show vaccine works in kids 6 months and up, FDA says

Moderna Inc.’s COVID-19 vaccine is effective in children and adolescents, with mostly mild to moderate side effects, the U.S. Food and Drug Administration staff said.

Benzinga

Cybin Moves Forward With Phase 1/2a Clinical Trial For Treatment Of Major Depressive Disorder

Cybin Inc.

Reason

Short Circuit: A Roundup of Recent Federal Court Decisions

Rubber stamps, pole cameras, and personal vendettas.

The Independent UK

NOT REAL NEWS: A look at what didn't happen this week

Social media users shared a range of false claims this week

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The Independent UK

Marathon US hearings to decide fate of COVID shots for tots

Next week brings a marathon of hearings as the U.S. decides whether to open COVID-19 vaccinations to kids under 5

Benzinga

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.

Tribune News Service

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.

Benzinga

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

The U.S.

Bangkok Post

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.

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