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The Latest Breaking News from FDA

See Why Did InflaRx Pause Late-Stage Vilobelimab Trial In Chronic Skin Condition

InflaRx N.V. (NASDAQ: IFRX) has received an advice letter from the FDA about the vilobelimab Phase 3 program for hidradenitis suppurativa (HS), a condition that causes small, painful lumps to form under the skin.

Benzinga

Masimo's SedLine Brain Function Monitor Sensor Scores FDA Approval For Pediatric Use

The

Benzinga

Bristol Myers' Opdivo Under Priority FDA Review In Neoadjuvant Lung Cancer Setting

The

Benzinga

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PLX: MAA Submitted

By John Vandermosten, CFA NYSE:PLX READ THE FULL PLX RESEARCH REPORT

Benzinga

AstraZeneca, GSK's COVID-19 Therapies Lose Efficacy Against Omicron's Subvariants

The FDA authorized an increased dose in the case of AstraZeneca Plc's (NASDAQ:

Benzinga

22nd Century Group Welcomes Dr. Robert Califf's Confirmation As FDA Commissioner

22nd Century Group, Inc. (NASDAQ: XXII) an agricultural biotechnology company focused on tobacco harm reduction, congratulated Dr.

Benzinga

FDA Approves Eli Lilly's Jardiance In Broader Heart Patient Population

The FDA approved Eli Lilly And Co (NYSE:LLY) and partner Boehringer Ingelheim's drug, Jardiance, for expanded use in reducing the risk of death and hospitalization for all patients with heart failure. Initially approved by the FDA in 2014 for type 2 diabetes patients, the drug's use was expanded last year in some adults living with heart failure…

Benzinga

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The Daily Biotech Pulse: Lilly's Jardiance Gets Nod For Heart Failure, Pulmatrix Announces Reverse Split, Reata Awaits FDA Decision

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

Benzinga

Editorial: FDA should pull ineffective pregnancy drug Makena until we know it works

The U.S. Food and Drug Administration accelerated the approval of a drug called Makena meant to prevent premature births. Now there’s mounting evidence that the drug does not work. The FDA should use its authority to pull Makena from the market until and unless the company that makes it can…

Los Angeles Times

Why Rhythm Pharmaceuticals Shares Are Falling Today

The FDA has extended the review period for Rhythm Pharmaceuticals Inc's (NASDAQ:RYTM) supplemental marketing application for Imcivree (setmelanotide) for obesity and control of hunger with Bardet-Biedl Syndrome (BBS) or Alström syndrome. The Prescription Drug User Fee Act (PDUFA) goal date has been revised to June 16, 2022, from March 16. FDA requested additional subgroup analyses…

Benzinga

The Government's Coronavirus Response Was a Complete Failure. Who Will Be Held Accountable?

From the CDC to the FDA, there are too many missteps to list.

Reason

The Daily Biotech Pulse: Orphazyme Plunges On Regulatory Setback In Europe, Pulmonx Earnings Disappoint, Amicus Declines To Spin Off Genetic Medicine Company

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

Benzinga

FDA Pushes United Therapeutics-MannKind Tyvaso DPI's Decision Date; United Therapeutics' Q4 Misses Consensus

United Therapeutics Corp (NASDAQ: UTHR) and its partner MannKind Corp (NASDAQ: MNKD) have received an FDA information request letter for

Benzinga

BioMarin Clocks Flat Q4 Sales Despite Erosion oF US Kuvan Market

BioMarin Pharmaceutical Inc (NASDAQ:BMRN) reported a 1% Y/Y decrease in Q4 revenue to $449.8 million, beating the consensus estimate of $442.39 million. The decline was attributable to lower sales from Kuvan and Naglazyme, cushioned by higher revenues from Aldurazyme, Vimizim, and Palynziq. Kuvan sales decreased 23% to $ 68.5 million, primarily due…

Benzinga

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Tribune News Service

FDA authorizes first condom specifically marketed for anal sex

The U.S. Food and Drug Administration on Wednesday announced its first-ever authorization of a condom specifically meant for anal sex.

Benzinga

The Daily Biotech Pulse: Kodiak Sinks On Adverse Study Outcome, Marinus Flags Delay In Clinical Trial, Mainz Biomed Gains On Positive Regulatory Development

Here's a roundup of top developments in the biotech space over the last 24 hours. Stocks In Focus Kodiak's Wet AMD Treatment KSI-301 Did Not Meet Primary Endpoint In Phase 2b/3 Study

Benzinga

MediPharm Labs Debuts On US Pharmaceutical Market With Submission Of FDA DMF

CBD-based pharmaceutical company MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) has completed a Drug Master File (DMF) process for CBD Active Pharmaceutical Ingredient (API) for the US Federal Drug Administration (FDA).

Benzinga

FDA Approves Medtronic's Recharge-Free Sacral Nerve Stimulation Therapy For Bladder, Bowel Control

The FDA has approved Medtronic plc's (NYSE:

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news in one place.

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Benzinga

73 Biggest Movers From Yesterday

Gainers Imperial Petroleum Inc. (NASDAQ: IMPP) jumped 63.1% to close at $0.80 on Tuesday after declining around 7% on Friday.

Asharq Al-Awsat

FDA Approves New Smartphone App for Insulin Delivery

Smartphones interfere in everything in our life today, and mobile apps have become able to perform things that we never imagined before. Among these are healthcare and therapeutics, as many apps available in app stores are aimed at easing patients’ lives and help them face their diseases and cope with…

Benzinga

Mid-Afternoon Market Update: US Stocks Pare Losses; Meritor Shares Spike Higher

U.S. stocks pared back some losses toward the end of trading on Tuesday. Russian President Vladimir Putin said he would recognize the independence of two Russian-led breakaway regions of Ukraine and ordered Russian troops to go into eastern Ukraine.

Benzinga

Provention Bio Resubmits Teplizumab Application In US For Type-1 Diabetes

Provention Bio Inc (NASDAQ: PRVB) has

Benzinga

50 Stocks Moving In Tuesday's Mid-Day Session

Gainers Indonesia Energy Corporation Limited (NYSE: INDO) jumped 75.2% to $7.87. Imperial Petroleum Inc. (NASDAQ: IMPP) rose 52.9% to $0.7500 after declining around 7% on Friday.

Benzinga

Mid-Day Market Update: Stocks Extend Losses; Dow Tumbles Over 400 Points

U.S. stocks extended its earlier losses midway through trading on Tuesday, amid rising tensions between Russia and Ukraine. Russian President Vladimir Putin said he would recognize the independence of two Russian-led breakaway regions of Ukraine and ordered Russian troops to go into eastern Ukraine.

Benzinga

CbdMD Requests FDA Remove Drug Exclusion For CBD And Examine Its Safety Submission

Natural Products Association filed a Citizen's Petition on cbdMD's (NYSE: YCBD) behalf with the Food and Drug Administration (FDA) requesting it remove the drug exclusion for CBD and review the company's extensive dossier of identity, safety and quality data.

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