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The Latest Breaking News from FDA

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

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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

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.

Tribune News Service

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

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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:

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.

Benzinga

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…

Asharq Al-Awsat

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

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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.

Benzinga

BeiGene's Brukinsa Applications Under FDA, European Review For Leukemia

The

Benzinga

Why Ocugen Shares Are Rising

Ocugen Inc (NASDAQ: OCGN) shares are trading higher by 23.8% at $4.28 Tuesday morning after the company announced the FDA lifted its clinical hold on the company's COVID-19 vaccine study in the US.

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Benzinga

FDA Rejects Zosano Pharma's Application For Zolmitriptan Microneedle System Again, Shares Plunge

The FDA has issued a response letter to Zosano Pharma Corp (NASDAQ:

Benzinga

Flora Growth Files Its Cannabinoid Food And Beverage Products To Colombian-FDA

Flora Growth Corp. (NASDAQ: FLGC) has filed twenty-three cannabinoid-infused food and beverage products with the Instituto Nacional de Vigilancia de Medicamentos y Alimentos, similar to the US FDA.

Benzinga

FDA Lifts Clinical Hold On Ocugen's COVID-19 Vaccine Study In US

The FDA has lifted its clinical hold on Ocugen Inc's (NASDAQ:

Benzinga

FDA Issues 'Refusal To File' To Allarity Therapeutics' Dovitinib In Kidney Cancer

The FDA has provided Allarity Therapeutics Inc (NASDAQ:

Benzinga

Homology Medicines Stock Plunges After FDA Clinical Hold On Gene Therapy Trial

The FDA has placed a clinical hold on Homology Medicines Inc's (NASDAQ:

Benzinga

Abbott's CardioMEMS HF System Scores FDA Nod For Earlier-Stage Heart Failure

The

Bangkok Post

Watch what you eat

Earlier this month, children in various provinces across Thailand including Chiang Mai, Phetchaburi, Saraburi, Trang and Kanchanaburi suddenly developed acute conditions, including breathing difficulty, paleness, fatigue and eventually methemoglobin -- a dysfunctional form of haemoglobin that is incapable of transporting oxygen -- after eating unbranded sausages.

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