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The Latest Breaking News from FDA

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…

Benzinga

COVID vaccine strategy still murky after FDA experts meet

Axios

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InflaRx Climbs More Than 40%, Here's 58 Biggest Movers From Yesterday

Gainers Agile Therapeutics, Inc. (NASDAQ: AGRX) shares climbed 89.8% to close at $2.41 on Tuesday. Agile Therapeutics shares climbed over 10% on Monday amid the Supreme Court overturning Roe V Wade.

Benzinga

FDA approves use of Evusheld

The Food and Drug Administration has approved the use of Evusheld, a combination of long-acting antibodies, for prevention of Covid-19, FDA director Paisal Dankhum said on Wednesday.

Bangkok Post

COVID shots should get omicron-targeted update, FDA advisers say

COVID-19 shots from Pfizer Inc. and Moderna Inc. should be updated to include components that target the highly transmissible omicron variant, the version of the virus that causes most of the world’s cases, U.S. regulatory advisers said.

Tribune News Service

Canada needs to invest more money into science innovation to help prevent the next global crisis

Canada has lagged behind its peer nations in innovation for decades. Currently, Canada is ranked 11th out of the 16 similarly developed countries assessed. While our “C” grade is a moderate improvement over our previous “D” grade, innovation still remains a barrier to high-quality job creation and economic prosperity in…

The Conversation

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Verrica Holds Type A Meeting With FDA For Potential Approval Of Skin Infection Candidate

The U.S. Food and Drug Administration (FDA) convened a Type A meeting with Verrica Pharmaceuticals (NASDAQ: VRCA) regarding the course of action for the clearance of its drug candidate VP-102.

Benzinga

Schrödinger's Initial-Stage Cancer Study Gains FDA Clearance

Schrödinger Inc. (NASDAQ: SDGR) announced that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application for the drug candidate SGR-1505 in patients with relapsed or refractory B-cell lymphoma.

Benzinga

The Daily Biotech Pulse: Kezar Life Surges On Positive Kidney Disease Trial Data, FDA Rejects Spero Therapeutics' Tebipenem, Graybug Reviews Strategic Alternatives

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

Benzinga

Cybin's Psilocybin Analog CYB003 Gets FDA Clearance For Trial To Potentially Treat Major Depressive Disorder

Psychedelic biopharma company Cybin Inc. (NEO: CYBN) has received FDA Investigational New Drug Application (IND) approval for a Phase 1/2a clinical trial evaluating its proprietary CYB003 for treating major depressive disorder (MDD).

Benzinga

New weight-loss treatment is marked by heavy marketing and modest results

First came the “edible billboard,” which appeared last year during the holidays in New York’s East Village loaded with cake treats. Then, in late January, came the national marketing campaign, with TV and digital media promoting the idea that trying to lose weight doesn’t mean a person can’t enjoy eating.

Tribune News Service

BCTX: New Sites Expand Bria-IMT Trial

By John Vandermosten, CFA NASDAQ:BCTX READ THE FULL BCTX RESEARCH REPORT

Benzinga

ESSA Pharma's EPI-7386 Monotherapy / Combo Therapy Show Early Activity Against Prostate Cancer

ESSA Pharma Inc (NASDAQ:EPIX) presented clinical results from the Phase 1a dose-escalation study of EPI-7386 as a monotherapy for metastatic castration-resistant prostate cancer (mCRPC) resistant to current standard-of-care therapies. The initial data from 36 patients demonstrate that EPI-7386 was well-tolerated, exhibited a favorable pharmacokinetic profile, and demonstrated initial anti-tumor activity in a heavily…

Benzinga

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news in one place.

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Benzinga

Gilead Again Seeks HIV Drug Approval From FDA After Addressing Vial Compatibility Issues

Gilead Sciences (NASDAQ: GILD) resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection.

Benzinga

Spero Therapeutics' Shares Plunge As FDA Issued Refusal Letter For Urinary Tract Infection Candidate

The U.S.

Axios

Abortion rights activists plot next legal steps

Abortion rights advocates are considering a number of options to legally challenge state bans.

Salon

Throw out this Panera corn chowder ASAP

The product in question was only distributed in select supermarkets across 12 different states

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Benzinga

New York Judge Denies Bristol Myers Claim To Dismiss Lawsuit Over Delayed Cancer Drug Approval: Reuters

According to a Reuters report, U.S. District Judge Jesse Furman in Manhattan refused to dismiss a $6.4 billion lawsuit accusing Bristol Myers Squibb Co (NYSE:BMY) of delaying its Breyanzi cancer drug to avoid payments to former Celgene shareholders. The judge rejected Bristol Myers' claim that it was never properly notified about its alleged default…

Benzinga

3 Women's Health Stocks Are Soaring Following Roe v. Wade Ruling

Three days after the U.S. Supreme Court struck down Roe v. Wade in one of the most potentially impactful rulings of the last century, a handful of women's health stocks are on the move on Monday in response to the news.

The Independent UK

Medication abortion is common, effective, and under attack by Republicans

Most abortions in the US and overseas involve pills that can be taken at home, but GOP lawmakers have launched a new war on drugs, Alex Woodward reports

The Independent UK

US grapples with whether to modify COVID vaccine for fall

U.S. health authorities are facing a critical decision: whether to offer new COVID-19 booster shots this fall that are modified to better match the latest changes of the shape-shifting coronavirus

Benzinga

The Daily Biotech Pulse: CHMP Backs AstraZeneca's Breast Cancer Therapies, Ipsen Buys Epizyme, FDA Holds For Nuvation Bio, Astellas Studies

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

StockNews.com

Altria is Still a Buy After FDA Orders Pulling JUUL Products Off the Market

Shares of Tobacco giant Altria (MO), a significant stakeholder of Juul Labs, slid last week on the news of the FDA preparing to order removing e-cigarette maker Juul’s products from the U.S. market. However, MO rebounded the following day as investors did not foresee any significant impact of this development…

Benzinga

Axsome Therapeutics Rallies 40% On FDA Product Label Proposal, But Analyst Remains Skeptical

Axsome Therapeutics Inc (NASDAQ: AXSM) shares rallied 40% on Monday morning after the company received some positive news from the U.S. Food and Drug Administration regarding its AXS-05 novel treatment for MDD (depression).

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