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The Latest Breaking News from FDA

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

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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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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…

Benzinga

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

The Guardian - US

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…

Benzinga

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.

Chicago Tribune

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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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Benzinga

The Daily Biotech Pulse: Karyopharm Flags Delay In Selinexor Label Expansion, Finch, Celyad Hit With Clinical Holds, Adagene Strikes R&D Collaboration With Sanofi

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

Benzinga

Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates

The Food and Drug Administration approval calendar was light in February. Nevertheless, the month saw regulatory nods accorded to some breakthrough therapies.

McClatchy Washington Bureau

Don’t use these 3 unauthorized COVID tests, FDA warns. You might get a false result

There are three COVID-19 tests distributed in the U.S. to avoid and if you already have any of them, don’t use them, the Food and Drug Administration is warning of the unauthorized tests.

Benzinga

GenScript Losses Widen, But Investors Focus on Newly Approved Cancer Treatment

Key takeaways: GenScript Biotech said it lost up to $519 million last year, with its Legend Biotech unit accounting for nearly 70% of that Legend Biotech’s Cilta-cel CAR-T cell therapy product was approved by the FDA on Monday, and could become a major cash cow for GenScript Biotech By Molly…

Benzinga

Gilead Hit By FDA Complete Response Letter For Lenacapavir In HIV Infection

The FDA has issued a complete response letter (CRL) for Gilead Sciences Inc's (NASDAQ:GILD) application for lenacapavir for heavily treated multi-drug resistant (MDR) HIV-1 infection. Lenacapavir is an investigational, long-acting HIV-1 capsid inhibitor. In the CRL, the FDA has cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir with the…

Benzinga

Cardiol Therapeutics To Include Vaccinated Participants In Cannabidiol COVID-19 Trial

The FDA and regulatory agencies in Brazil & Mexico have cleared Cardiol Therapeutics Inc (NASDAQ: CRDL) to modify the inclusion criteria for the LANCER trial to

Benzinga

The Daily Biotech Pulse: Legend Biotech, CTI Biopharma Receive FDA Approvals, AbbVie Announces Delay In Skyrizi Review, Editas Gains On CRISPR Patent Resolution

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

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