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The Latest Breaking News from FDA

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

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

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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.…

Benzinga

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?

Reason

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).

Benzinga

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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…

The Conversation

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…

Benzinga

COVID vaccine strategy still murky after FDA experts meet

Axios

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

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Tribune News Service

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.

The Conversation

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…

Benzinga

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.

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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).

Tribune News Service

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.

Benzinga

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

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

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