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The Latest Breaking News from FDA

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

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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:

Benzinga

FDA Approves JNJ-Legend Biotech Partnered Blood Cancer Therapy

The

Benzinga

CTI BioPharma's Bone Marrow Cancer Drug Scores FDA Approval

The FDA approved CTI BioPharma Corp's (NASDAQ:CTIC) Vonjo (pacritinib) for treating adult patients with myelofibrosis, a type of bone marrow cancer with low blood platelets count. Pacritinib is a JAK inhibitor and will compete with Incyte Corporation's (NASDAQ:INCY) Jakafi and Bristol Myers Squibb's Co (NYSE:BMY) Inrebic, which were approved in 2011 and 2019, respectively for myelofibrosis. CTI…

Benzinga

FDA Rejects Amryt Pharma's Oleogel-S10 Application For Skin Blistering Disorder

Amryt Pharma Plc (NASDAQ: AMYT) has

Benzinga

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CorMedix Refiles DefenCath US Application For Catheter-Related Bloodstream Infections

CorMedix Inc (NASDAQ: CRMD) has resubmi

Benzinga

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

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

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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

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.

Los Angeles Times

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…

Benzinga

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…

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Reason

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.

Benzinga

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…

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).

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