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The Latest Breaking News from FDA

LAVA Therapeutics Shares Interim LAVA-051 Data From Early-Stage Cancer Trial

LAVA Therapeutics NV (NASDAQ:LVTX) announced initial data from its first clinical study with LAVA-051. The presentation will include data from the first three cohorts of the LAVA-051 Phase 1/2a trial, along with preclinical data on its two lead programs, LAVA-051 and LAVA-1207. The first three dose-escalation cohorts showed LAVA-051 to be safe and…

Benzinga

Why Alpine Immune's Shares Are Falling Today

The FDA has placed a partial clinical hold on Alpine Immune Sciences Inc's (NASDAQ:ALPN) NEON-2 trial evaluating davoceticept (ALPN-202) in combination with pembrolizumab in adults with advanced malignancies. The partial clinical hold was prompted by Alpine's report of patient death in the NEON-2 trial. The participant had choroidal melanoma previously treated with nivolumab and…

Benzinga

NOVN: A Banner Year for Novan - 2021 Results

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

Benzinga

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Is Ra Medical Systems a Good Penny Stock to Own?

The shares of commercial-stage medical device maker Ra Medical Systems (RMED) have tumbled 92.7% in price over the past year due to investor concerns surrounding the company’s poor financial health. Also, given the uncertainty surrounding the FDA’s approval of its DABRA catheter laser system, the question becomes, is the penny…

StockNews.com

Electrical Stimulation Zaps Premature Ejaculation

FDA-approved vPatch can prolong the time to orgasm by a factor of three and a half. The disposable patch will cost about $15.

Zenger

Local Covid vaccines undergo human trials

Four out of more than 20 Covid-19 vaccine candidates being developed in Thailand are now being tested on humans, the final process required before they are submitted for approval by the Food and Drug Administration (FDA), the government said on Saturday.

Bangkok Post

Analysts Move To Sidelines On Vicarious Surgical After Regulatory Update

Piper Sandler has downgraded Vicarious Surgical Inc (NASDAQ:RBOT) to Neutral from Overweight with a price target of $7, down from $16, below expected Q4 results. A majority of the earnings call focused on the Company's regulatory update. Vicarious announced its plans to pursue a De Novo FDA pathway, including a pre-market study, for its…

Benzinga

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Analysts Cut Price Target On Aziyo Biologics As Q4 Earnings Fall Short Of Expectations

Aziyo Biologics Inc (NASDAQ:AZYO) Q4 FY21 sales decreased 13% to $10.9 million, missing the consensus of $11.06 million. Excluding the contribution of FiberCel sales, which the product's distributor discontinued in Q2 of 2021, Q4 sales increased 6% Y/Y. The 510(k) application for CanGaroo RM, the Company's next-generation envelope, remains on track for submission…

Benzinga

Despite More Than Double Q4 Sales, Chembio Diagnostics Posts Deeper Losses

Chembio Diagnostics Inc's (NASDAQ:CEMI) Q4 sales increased 101% Y/Y to $20.6 million, beating the consensus of $13.55 million. Net product sales increased 154% to $17.4 million. Government grant, license, and royalty, and R&D revenue totaled $3.2 million, down 6%. Chembio posted a wider operating loss of $(13.97) million, compared to $(7.14) million…

Benzinga

The FDA is approving more drugs that haven’t been shown to work. Are patients being harmed?

LOS ANGELES — Federal regulators are increasingly approving medicines before studies have shown they work, leaving patients at risk of taking prescriptions that could harm but not help them.

Los Angeles Times

FDA Denies Pediatric EUA To Ocugen For Bharat Biotech's COVID-19 Vaccine Covaxin

The FDA has declined to issue an Emergency Use Authorization (EUA) for Covaxin for active immunization to prevent COVID-19 in individuals 2 to 18 years of age. Ocugen Inc (NASDAQ:OCGN) is working with the vaccine's developer, Bharat Biotech of India, to bring Covaxin to the U.S. Related: FDA Lifts Clinical Hold On Ocugen's COVID-19…

Benzinga

Why Ocugen Shares Are Falling

Ocugen Inc (NASDAQ: OCGN) shares are trading lower by 22.8% at $2.54 after the company announced the FDA declined to issue an EUA for COVAXIN for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 2 to 18 years of age.

Benzinga

24 Stocks Moving in Friday's Pre-Market Session

Gainers Statera Biopharma, Inc. (NASDAQ: STAB) rose 30.4% to $0.9520 in pre-market trading. Statera Biopharma recently submitted Phase 1 clinical trial protocol to the FDA for investigational treatment of long-haul COVID-19.

Benzinga

Tonix Pharmaceuticals Rockets Higher Thursday: Why Is The Penny Stock Flying?

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) shares are rallying higher Thursday after the company announced the FDA has granted Orphan-Drug Designation for TNX-2900 for the treatment of Prader-Willi syndrome.

Benzinga

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Benzinga

FDA Pushes TG Therapeutics' Ublituximab / Ukoniq Combo Therapy Applications In Blood Cancer Settings

The FDA has extended the review period of TG Therapeutics Inc's (NASDAQ:TGTX) biologics license application and supplemental New Drug Application for ublituximab in combination with Ukoniq (umbralisib) for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The Prescription Drug User Fee Act (PDUFA) goal date is postponed to June 25. The FDA notified…

Benzinga

APLIF: U.S. DoD to Provide Over US$10 Million in Funding for ATI-1701…

By David Bautz, PhD OTC:APLIF | TSX:APLI.TO READ THE FULL APLIF RESEARCH REPORT

Benzinga

WHO Conditionally Recommends Merck's COVID-19 Antiviral Pill For High-Risk Patients

A World Health Organization (WHO) panel has backed the use of Merck & Co Inc's (NYSE:MRK) COVID-19 antiviral pill for high-risk patients. The expert panel conditionally recommended molnupiravir for patients with non-severe disease at high risk of hospitalization, such as the immunocompromised, the unvaccinated, older people, and those with chronic conditions. The recommendation was…

Benzinga

AVITA Medical Inks Supply Pact With Premier For RECELL System

AVITA Medical Inc (NASDAQ:RCEL) has been awarded a group purchasing agreement with Premier Inc (NASDAQ:PINC) The new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for the RECELL System for the treatment of adult and pediatric patients with severe burns. The RECELL System is a…

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The Guardian - US

Reports of infant illnesses investigated following US formula recall

FDA and CDC urge parents to avoid feeding babies formula produced at Michigan facility operated by Abbott Nutrition

Benzinga

LSD And Magic Mushroom's Active Compound Appear To Have The Same Effects, New Study Finds

A new peer-reviewed study compared the effects of LSD and psilocybin, two substances currently standing as top molecules behind the recent psychedelic medicine boom. While both compounds have a rich history of human use, not much research has been dedicated to contrasting the effects they produce in human psychology. The…

Chicago Tribune

Abbott facing lawsuits, FDA investigation over recalled infant formula after reports of illness, death

Parents who bought recalled infant formulas made by Abbott Laboratories are filing proposed class-action lawsuits against Abbott, as the U.S. Food and Drug Administration investigates reports of three babies who became sick and two who died after consuming the formulas.

Benzinga

CBD In Children: Poll Finds Over One-Third Of Parents Think Consuming CBD Is Same As Cannabis, What About FDA?

About 80% of parents confirmed they know little to nothing about CBD use in children, according to a recent poll by the Universit

Benzinga

Sensus Healthcare Offloads Sculptura Assets To Focus On Core Dermatology Offerings

Sensus Healthcare Inc (NASDAQ:SRTS) sold its Sculptura assets to Empyrean Medical Systems for $15 million in cash. The sale included an inventory of Sculptura systems and parts, in addition to all related intellectual property. The Sculptura system provides targeted Directional Anisotropic Radiation Therapy (ART) and brachytherapy utilizing proprietary, state-of-the-art 3D Beam Sculpting to treat…

Benzinga

FDA Slaps Clinical Hold On Celyad's Phase 1 Colorectal Cancer Trial

The FDA has issued a clinical hold on Celyad Oncology SA's (NASDAQ:CYAD) CYAD-101-002 (KEYNOTE-B79) Phase 1b trial due to insufficient information to assess risk to study subjects. As previously disclosed, the Company announced that it was voluntarily pausing the CYAD-101-002 trial to investigate reports of two fatalities in the study. Celyad Oncology is a clinical-stage biotechnology…

Benzinga

See Why Did Finch Therapeutics Halt Enrolment In Late-Stage C. Difficile Infection Trial

The FDA has issued a clinical hold letter to Finch Therapeutics Group Inc's (NASDAQ:FNCH) PRISM4 Phase 3 trial of CP101 in recurrent C. difficile infection (CDI). The Company has paused enrollment in the trial as the FDA has asked for additional information about Finch's SARS-CoV-2 donor screening protocols. The FDA placed Finch's investigational new…

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