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The Latest Breaking News from FDA

Avadel Cuts Workforce, Optimizes Cost Structure To Support This

Avadel Pharmaceuticals plc (NASDAQ: AVDL) announced its steps to explore every available pathway to accelerate the FDA approval of its lead drug candidate, FT218, before June 2023.

Benzinga

AstraZeneca Says Imfinzi/Chemo Combo Shows Promising Action In Late-Stage Lung Cancer Study

AstraZeneca Plc (NASDAQ:AZN) announced high-level results from a planned interim analysis of the AEGEAN Phase 3 trial of Imfinzi (durvalumab) combined with neoadjuvant chemotherapy in patients with resectable non-small cell lung cancer (NSCLC). The data showed that Imfinzi plus neoadjuvant chemo before surgery demonstrated a statistically significant and meaningful improvement in pathologic complete…

Benzinga

Why Sanofi Shares Are Falling Today

The FDA has placed Sanofi SA's (NASDAQ:SNY) Phase 3 studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold. New enrollment in the U.S. is paused, and participants in the U.S. who have been in the trial for fewer than 60 days shall suspend the study drug. The participants who…

Benzinga

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US Government Calls For Additional Doses Of Pfizer/BioNTech COVID-19 Vaccine

Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have announced a new vaccine supply agreement with the U.S. government. Under the agreement, the U.S. government will receive 105 million doses (30 µg, 10 µg and 3 µg). This may include adult omicron-adapted COVID-19 vaccines, subject to the FDA authorization. The doses are planned to be delivered…

Benzinga

COVID vaccination reboot coming this fall to add tweaks for new coronavirus variants

The FDA will have to decide the exact recipe. But expect a combination shot that adds protection against omicron or some of its newer relatives to the original vaccine.

Chicago Sun-Times

This Healthcare Stock Surges Around 115%, Here's 74 Biggest Movers From Yesterday

Gainers Allena Pharmaceuticals, Inc. (NASDAQ: ALNA) shares surged 114.3% to close at $0.2550 on Wednesday after the company announced it has terminated its previously announced at-the-market offering.

Benzinga

Editorial: Drastically reducing nicotine levels will save a lot of lives

Nicotine kills. Oh, not directly, for the most part. It’s just so addictive that cigarette smokers find it nearly impossible to quit a product that subtracts years off their lives, causes cancer, chronic obstructive pulmonary disease, strokes and heart disease, along with worsening Type 2 diabetes. In 2018, more than…

Los Angeles Times

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What you need to know about monkeypox

The World Health Organization said June 25 that monkeypox wasn’t yet a public health emergency of international concern. More than 4,500 cases have been reported worldwide, with more than 300 in the U.S.

Tribune News Service

Baby neck floats can cause ‘death or serious injury’, FDA warns

Agency says they are sometimes marketed as water-therapy products

The Independent UK

Texas Sen. Ted Cruz blasts Sesame Street – again – after Elmo gets the coronavirus vaccine

WASHINGTON — With a little green bandaid on his furry red arm, Elmo, the beloved 3 1/2-half-year-old Muppet on the long-running children’s PBS program Sesame Street, said “there was a little pinch, but it was okay” when he received his coronavirus vaccine this week.

Tribune News Service

Analysts Still Believe Verrica's Ycanth Is Approvable Despite FDA Response Letter

Verrica Pharmaceuticals Inc (NASDAQ:VRCA) held a Type A meeting with the FDA regarding the path forward for the resubmission and potential approval of Ycanth (VP-102) for molluscum contagiosum. HC Wainwright says VP-102 was approvable, and at the time of the Complete Response Letter (CRL), Verrica had already engaged a potential alternate solution supplier. It reiterates…

Benzinga

5 "Strong Buy" Pharmaceutical Stocks to Own for the Long Haul

The inelastic demand and rising investments in research and development should drive the pharmaceutical industry’s growth in the long run. Therefore, pharmaceutical stocks AbbVie (ABBV), Amgen (AMGN), Catalyst (CPRX), Novo Nordisk (NVO), and Vertex (VRTX), which possess sound fundamentals, could be solid long-term investments. These stocks are rated Strong Buy…

StockNews.com

FDA Green Lights Ceruvia's Phase 2 Psilocybin Trial Program For Obsessive-Compulsive Disorder Treatment

Clinical-stage biopharma company Ceruvia Lifesciences recently received FDA approval for its Investigational New Drug (IND) application for a Phase 2 clinical trial to determine the efficacy and safety of proprietary synthetic psilocybin (SYNP-101) in treating obsessive-compulsive disorder (OCD).&nbs

Benzinga

Pfizer, Moderna Analysts Respond To FDA COVID Booster Ruling: 'Revenues Will Decline'

The Food and Drug Administration’s panel of independent vaccine experts recently voted 19 to 2 to recommend a new batch of COVID-19 booster shots targeting the omicron variant this fall. The news, announced Tuesday, June 28, could have a big impact on the share prices of vaccine makers.

Benzinga

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Benzinga

Revive Therapeutics Data Access Plan Approved By The FDA; Partial Unblinded Data In Company Hands

Revive Therapeutics Ltd. (OTC: RVVTF) moved closer towards potential endpoint change in their Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19.

Benzinga

Why Is Allena Pharmaceuticals Jumping By 207%? 45 Stocks Moving In Wednesday's Mid-Day Session

Gainers Allena Pharmaceuticals, Inc. (NASDAQ: ALNA) jumped 207% to $0.3650 after the company announced it has terminated its previously announced at-the-market offering.

Benzinga

The Daily Biotech Pulse: Eli Lilly Modifies COVID-19 Treatment Pact, Oyster Point Outlines Restructuring Plan, Icosavax Posts Interim RSV Vaccine Data

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

InflaRx Provides Development Update For Vilobelimab In Skin Disorder, COVID-19

InflaRx N.V. (NASDAQ:IFRX) provided a development update for its monoclonal anti-C5a antibody, vilobelimab, in pyoderma gangrenosum (PG) and severe COVID-19. The FDA and the European Medicines Agency (EMA) have granted orphan drug designation to vilobelimab for PG. PG is a rare condition that causes large, painful sores (ulcers) to develop on the skin.…

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Reason

Can the FDA Stop States From Banning Abortion Pills?

The FDA could work with the Department of Justice to sue states over mifepristone bans. But should it?

Benzinga

ALX Oncology Shares Soar As FDA Grants Orphan Drug Status To Blood Cancer Candidate

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ALX Oncology Holdings’ (NASDAQ: ALXO) Evorpacept for the treatment of patients with acute myeloid leukemia (AML).

The Conversation

The FDA and Juul are fighting over a vape ban, but the role of e-cigarettes in the world of tobacco abuse is not clear-cut

On June 23, 2022, the U.S. Food and Drug Administration announced that all Juul products must be removed from U.S. markets. This decision essentially broadened an existing ban on teen use of the company’s nicotine e-cigarettes to include adults as well. The next day, Juul asked a federal appeals court…

Benzinga

Beyond Air Scores First FDA Approval For LungFit PH In Respiratory Failure

The FDA has approved Beyond Air Inc's (NASDAQ:XAIR) LungFit PH to treat term and near-term neonates with hypoxic respiratory failure (often referred to as persistent pulmonary hypertension of the newborn or PPHN). LungFit PH is the initial device from the LungFit therapeutic platform of nitric oxide generators. It is the first FDA-approved product…

Benzinga

LiveOne And 24 Stocks Moving Premarket

Gainers Allena Pharmaceuticals, Inc. (NASDAQ: ALNA) rose 92.9% to $0.2295 in pre-market trading. Allena Pharmaceuticals said it previously entered into at market issuance sales agreement with B. Riley Securities.

Benzinga

Oyster Point Outlines Restructuring Plan With Savings Of Up To $48M In 2023

Oyster Point Pharma Inc (NASDAQ:OYST) will implement an operating expense streamlining plan to reduce employee and non-employee expenses (up to 50 roles) across the organization. The company plans to continue to drive the launch of Tyrvaya with approximately 150-200 field-based sales resources. The plan is expected to reduce operating expenses by approximately $6…

Axios

COVID vaccine strategy still murky after FDA experts meet

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