FDA - Pharma Rep Focus

Ouster of Peter Marks & Mass FDA Layoffs Have Biotech Sector Bracing for Regulatory Disruptions

MedCity News

APRIL 2, 2025

As the FDAs top biologics official, Peter Marks oversaw regulation of cell and gene therapies. The departure of Marks and mass layoffs throughout the FDA raise concerns about the agencys ability to review and potentially approve such treatments.

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FDA Biopharma Pharma

FDA Nod for BridgeBio Brings New Competition to Blockbuster Pfizer Cardio Drug

MedCity News

NOVEMBER 25, 2024

But new competition to both products could come soon from Alnylam Pharmaceuticals, now set to receive an FDA decision in this indication by late March. The post FDA Nod for BridgeBio Brings New Competition to Blockbuster Pfizer Cardio Drug appeared first on MedCity News.

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FDA Takes Step Toward Removal of Ineffective Decongestants From the Market

MedCity News

NOVEMBER 8, 2024

The FDA has proposed removing oral phenylephrine from its guidelines for over-the-counter drugs due to inefficacy as a decongestant. The post FDA Takes Step Toward Removal of Ineffective Decongestants From the Market appeared first on MedCity News.

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‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer

MedCity News

NOVEMBER 10, 2024

Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. The post ‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer appeared first on MedCity News.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. What will the future hold for clinical research?

FDA

Gene Therapy in an Implant: Neurotech Lands First FDA Approval in Rare Vision Disorder

MedCity News

MARCH 9, 2025

Neurotech Pharmaceuticals surgically implanted cell and gene therapy, Encelto, is now FDA approved to treat macular telangectasia type 2 (MacTel). The post Gene Therapy in an Implant: Neurotech Lands First FDA Approval in Rare Vision Disorder appeared first on MedCity News.

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Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M

MedCity News

NOVEMBER 6, 2024

The biotech received the voucher last year alongside the regulatory decision that made its drug Daybue the first FDA-approved treatment for the rare disease Rett syndrome. The post Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M appeared first on MedCity News.

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PTC Therapeutics Wins First FDA Approval for a Gene Therapy Dosed Directly Into the Brain

MedCity News

NOVEMBER 14, 2024

FDA approval for the product comes two years after it won its first regulatory approvals in Europe. The post PTC Therapeutics Wins First FDA Approval for a Gene Therapy Dosed Directly Into the Brain appeared first on MedCity News.

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Patient Dies in Gene Therapy Trial, But FDA Permits Neurogene to Proceed With Low Dose

MedCity News

NOVEMBER 22, 2024

A patient death in a clinical trial usually prompts the FDA to impose a clinical hold. But Neurogene is able to avoid a lengthy clinical trial pause largely because of its participation in an FDA pilot program intended to speed up the development of therapies for rare diseases.

FDA

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Astellas nabs class-first FDA approval for CLDN18.2 gastric cancer med Vyloy

Fierce Pharma

OCTOBER 18, 2024

After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. Astellas' Vyloy won an FDA approval to treat gastric or gastroesophageal junction adenocarcinoma patients whose tumors are CLDN18.2

FDA

FDA Manufacturing Patients

FDA removes Novo's Wegovy from shortage list, marking end of semaglutide supply rout in US

Fierce Pharma

OCTOBER 31, 2024

Less than a month after the FDA removed Eli Lilly’s tirzepatide from its shortage list, the agency has done the same for Novo Nordisk’s rival GLP-1 semaglutide, potentially signaling the end of a d | The FDA this week revised its shortage list to note that the.25

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FDA Medicine

Eli Lilly’s Zepbound Becomes First FDA-Approved Drug Therapy for Sleep Apnea

MedCity News

DECEMBER 22, 2024

The post Eli Lillys Zepbound Becomes First FDA-Approved Drug Therapy for Sleep Apnea appeared first on MedCity News. Zepbounds clinical tests in obstructive sleep apnea showed improvement in breathing disruptions that were accompanied by reductions in body weight.

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Axsome Aims for FDA Filing in Alzheimer’s Agitation Despite Mixed Bag of Phase 3 Data

MedCity News

DECEMBER 30, 2024

Axsome Therapeutics aims to offer an alternative to Rexulti, a Lundbeck and Otsuka Pharmaceutical product that is the only FDA-approved Alzheimers agitation drug. The post Axsome Aims for FDA Filing in Alzheimers Agitation Despite Mixed Bag of Phase 3 Data appeared first on MedCity News.

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Vertex Pharma’s Opioid Alternative Wins FDA Approval, First in a New Class of Pain Meds

MedCity News

JANUARY 31, 2025

Vertex Pharmaceuticals Jounavx is now FDA approved, providing patients a non-opioid option for treating acute pain. The post Vertex Pharmas Opioid Alternative Wins FDA Approval, First in a New Class of Pain Meds appeared first on MedCity News.

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'It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says

Fierce Pharma

NOVEMBER 1, 2024

An FDA announcement last year of an investigation into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry. | said in an interview with Fierce Pharma.

FDA

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Bristol Myers Squibb Wins FDA Nod for Injectable Version of Blockbuster Cancer Drug

MedCity News

DECEMBER 30, 2024

Opdivo Qvantig, administered by injection in less than five minutes, is now FDA approved for solid tumor indications covered by Opdivo, a 30-minute intravenous infusion. The post Bristol Myers Squibb Wins FDA Nod for Injectable Version of Blockbuster Cancer Drug appeared first on MedCity News.

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Rare Metabolic Disease That Leads to Childhood Obesity Gets Its First FDA-Approved Drug

MedCity News

MARCH 27, 2025

Soleno Therapeutics Vykat XR is now FDA approved for treating hyperphagia, or excessive hunger, in patients with Prader-Willi syndrome. The post Rare Metabolic Disease That Leads to Childhood Obesity Gets Its First FDA-Approved Drug appeared first on MedCity News.

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Neurocrine Lands FDA Nod for First New Treatment in Decades for Rare Endocrine Disorder

MedCity News

DECEMBER 16, 2024

Neurocrine Biosciences Crenessity is now FDA approved for treating classic congenital adrenal hyperplasia (CAH), a rare and potentially fatal endocrine disorder. The post Neurocrine Lands FDA Nod for First New Treatment in Decades for Rare Endocrine Disorder appeared first on MedCity News.

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New FDA Approval Adds Chronic Kidney Disease to Ozempic’s Label

MedCity News

JANUARY 29, 2025

The new FDA approval comes as makers of GLP-1 drugs work to expand the uses of these products. The post New FDA Approval Adds Chronic Kidney Disease to Ozempics Label appeared first on MedCity News. Novo Nordisks type 2 diabetes drug Ozempic has expanded its label to include chronic kidney disease.

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FDA Biopharma Pharma

Novo Nordisk GLP-1 Drug Meets Goals of MASH Trial, Setting Stage for FDA & EMA Filings

MedCity News

NOVEMBER 1, 2024

The post Novo Nordisk GLP-1 Drug Meets Goals of MASH Trial, Setting Stage for FDA & EMA Filings appeared first on MedCity News. Based on these preliminary results, the company plans to seek U.S. and European Union approvals in this indication in 2025.

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FDA considers 'regulatory action' for bluebird's Skysona after blood cancer reports

Fierce Pharma

DECEMBER 2, 2024

The FDA is investigating reports of patients develo | The FDA is investigating reports of patients developing blood cancer after receiving bluebird bio’s gene therapy Skysona and is evaluating the need for “further regulatory action,” the U.S. agency said last week.

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Novartis Nabs First FDA Nod in Rare Kidney Disease, But Apellis Pharma Is on Its Heels

MedCity News

MARCH 23, 2025

Novartiss Fabhalta is the first FDA-approved therapy for C3 glomerulopathy. But Apellis Pharmaceuticals Empaveli has superior clinical data, and that drug has been submitted for FDA review in the same rare kidney disease as well as another one that does not yet have an approved therapy.

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Denali’s Data in Rare Enzyme Deficiency Keep It on Pace to Seek Speedy FDA Approval

MedCity News

FEBRUARY 6, 2025

Denali Therapeutics’ technology gets its drug across the protective membrane, and the biotech plans to seek accelerated FDA approval in this rare disease. The post Denalis Data in Rare Enzyme Deficiency Keep It on Pace to Seek Speedy FDA Approval appeared first on MedCity News.

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FDA reaffirms decision to erase Eli Lilly's tirzepatide from shortage list, halting future flow of knockoffs

Fierce Pharma

DECEMBER 19, 2024

The FDA has doubled down on its decision to remove Eli Lillys tirzepatide from its list of products that are in shortage. | The FDA has doubled down on its decision to remove Eli Lillys tirzepatide from its list of products that are in shortage.

FDA

After prior rejection, Iterum nabs long-sought FDA nod for oral UTI drug Orlynvah

Fierce Pharma

OCTOBER 25, 2024

Despite recent concerns from the FDA about potential off-label use and antimicrobial resistance, Dublin-based Iterum Therapeutics has scored a green light for its oral antibiotic sulopenem. The FDA nod marks the second approval this year for a uUTI medicine after two decades of stagnation in the field.

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FDA Medicine

Pfizer Ends Sangamo Alliance With Gene Therapy for Hemophilia on Cusp of FDA Filing

MedCity News

DECEMBER 31, 2024

The post Pfizer Ends Sangamo Alliance With Gene Therapy for Hemophilia on Cusp of FDA Filing appeared first on MedCity News. Pfizer is walking away from partner Sangamo Therapeutics ahead of expected regulatory submissions for the hemophilia A gene therapy they co-developed.

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FDA Biopharma Pharma

Look out, Pfizer: BridgeBio scores 'best-case' FDA nod for Attruby in cardiomyopathy

Fierce Pharma

NOVEMBER 25, 2024

With the nod, BridgeBio will challenge Pfizer’s powerhouse Vyndaqel franchise, which dominates the indication.

FDA

FDA Patients

FDA Approves First-in-Class GSK Antibiotic for Common Type of Urinary Tract Infection

MedCity News

MARCH 26, 2025

The FDA approved GSK antibiotic Blujepa as a treatment for uncomplicated urinary tract infections. The post FDA Approves First-in-Class GSK Antibiotic for Common Type of Urinary Tract Infection appeared first on MedCity News.

FDA

FDA Biopharma Pharma

Novo Nordisk asks FDA to prevent compounders from making copycat versions of GLP-1 star semaglutide

Fierce Pharma

OCTOBER 23, 2024

The war is on between compounding pharmacies making knockoff versions of popular weight loss drugs and pharma giants Novo Nordisk and Eli Lilly, who want to protect their right to sell their patent | Novo Nordisk has asked the FDA to prevent compounders from manufacturing copycat versions of its juggernaut diabetes and obesity treatments Ozempic and (..)

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Syndax Pharmaceuticals Leukemia Drug Wins a First-in-Class FDA Approval

MedCity News

NOVEMBER 18, 2024

The post Syndax Pharmaceuticals Leukemia Drug Wins a First-in-Class FDA Approval appeared first on MedCity News. Other companies developing menin inhibitors include Kura Oncology, Biomea Fusion, and Johnson & Johnson subsidiary Janssen.

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Supernus Wearable Device for Dosing Parkinson’s Drug Lands Long-Awaited FDA Approval

MedCity News

FEBRUARY 4, 2025

Approval of Onapgo comes after the FDA twice turned back applications for the drug/device combination product. The post Supernus Wearable Device for Dosing Parkinsons Drug Lands Long-Awaited FDA Approval appeared first on MedCity News.

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FDA Clears Withings’ New Blood Pressure Monitor That Allows Providers to Communicate Directly with Patients

MedCity News

DECEMBER 17, 2024

This week, the FDA granted clearance to Withings BPM Pro 2 cellular blood pressure monitor. The post FDA Clears Withings New Blood Pressure Monitor That Allows Providers to Communicate Directly with Patients appeared first on MedCity News. The device seeks to help providers scale remote patient monitoring for heart failure patients.

FDA

FDA Patients

In FDA adcomm, Lexicon gets another thumbs down for type 1 diabetes hopeful Zynquista

Fierce Pharma

NOVEMBER 1, 2024

On Halloween, Lexicon was haunted again as an FDA advisory committee voted 11-3 to reject Zynquista as an accompanying medication to insulin for those with type 1 diabetes (T1D).

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Transportation FDA Medical

Novartis' Pluvicto enters FDA orbit for expansion bid as agency requests 'flexibility'

Fierce Pharma

OCTOBER 29, 2024

The company made the decision in response to the FDA's request for "flexibility" in its review timeline, Novartis CEO Vas Narasimhan explained. . | Novartis didn't use a priority review voucher for Pluvicto's key application in an earlier treatment setting of prostate cancer.

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FDA Sales

After two rejections, FDA approves Mesoblast's first-of-its-kind cell therapy

Fierce Pharma

DECEMBER 19, 2024

An FDA advisory panel vote of 9-1 to recommend the approval of | An FDA advisory panel vote of 9-1 to recommend the approval of Mesoblast Limiteds graft versus host disease (GVHD) cell therapy was a cruel tease for the Australian company. regulator for its first approved drug.

FDA

FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official Bucks Agency Staff

MedCity News

JUNE 21, 2024

FDA reviewers concluded the data for Sarepta Therapeutics’ Elevidys were insufficient to show efficacy in the rare muscle disorder Duchenne muscular dystrophy. The post FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official Bucks Agency Staff appeared first on MedCity News.

FDA

FDA Biopharma Pharma

FDA Approval of Drug for Rare Tumors Enables SpringWorks to Challenge AstraZeneca

MedCity News

FEBRUARY 12, 2025

SpringWorks Therapeutics Gomekli is now FDA approved for treating tumors caused by the rare genetic disorder neurofibromatosis type 1. The post FDA Approval of Drug for Rare Tumors Enables SpringWorks to Challenge AstraZeneca appeared first on MedCity News.

FDA

FDA Biopharma Pharma

FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains

Fierce Pharma

NOVEMBER 12, 2024

Intercept received a complete response letter from the FDA, dashing the company’s hopes of turning Ocaliva’s accelerated green light into a traditional approval for the rare autoimmune disease primary biliary cholangitis.

FDA

FDA Pharmaceutical

FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions

MedCity News

JANUARY 2, 2025

Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory decisions. The post FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions appeared first on MedCity News.

FDA

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FDA Clears Gel That Can Stop Bleeding In Seconds

MedCity News

AUGUST 19, 2024

Cresilon snagged its second FDA clearance for human use. The FDA granted 510(k) clearance to Traumagel, the startup’s gel that can stop bleeding in just seconds, for temporary external use to control moderate to severe bleeding. The post FDA Clears Gel That Can Stop Bleeding In Seconds appeared first on MedCity News.

FDA

FDA Authorizes First At-Home, OTC Diagnostic Test for Syphilis

MedCity News

AUGUST 18, 2024

NOWDiagnostics’ First to Know has FDA De Novo marketing authorization as a new test for syphilis. The post FDA Authorizes First At-Home, OTC Diagnostic Test for Syphilis appeared first on MedCity News. The at-home product needs only a single drop of blood to test for this sexually transmitted infection.

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4 Things That Worry FDA Commissioner Robert Califf

MedCity News

OCTOBER 24, 2024

This week at HLTH, FDA Commissioner Robert Califf discussed the current state of healthcare AI. The post 4 Things That Worry FDA Commissioner Robert Califf appeared first on MedCity News.

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FDA Healthcare Healthcare Food and Drug Administration

Enabling Clinical Trial Innovation Through AI Regulation at FDA

MedCity News

JULY 29, 2024

As the FDA stakes its claim as the primary regulator of AI in healthcare, it must navigate the delicate balance between fostering innovation and ensuring safety and responsibility. The post Enabling Clinical Trial Innovation Through AI Regulation at FDA appeared first on MedCity News.

FDA

FDA Safety Healthcare Healthcare

Wearable Tumor-Zapping Medical Device Wins FDA Approval for Lung Cancer

MedCity News

OCTOBER 16, 2024

The FDA approved Novocure medical device Optune Luna as a treatment for advanced cases of non-small cell lung cancer. The post Wearable Tumor-Zapping Medical Device Wins FDA Approval for Lung Cancer appeared first on MedCity News. The wearable technology delivers electrical fields that kill cancer cells.

Medical

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Ouster of Peter Marks & Mass FDA Layoffs Have Biotech Sector Bracing for Regulatory Disruptions

FDA Nod for BridgeBio Brings New Competition to Blockbuster Pfizer Cardio Drug

Trending Sources

FDA Takes Step Toward Removal of Ineffective Decongestants From the Market

‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Gene Therapy in an Implant: Neurotech Lands First FDA Approval in Rare Vision Disorder

Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M

PTC Therapeutics Wins First FDA Approval for a Gene Therapy Dosed Directly Into the Brain

Patient Dies in Gene Therapy Trial, But FDA Permits Neurogene to Proceed With Low Dose

Astellas nabs class-first FDA approval for CLDN18.2 gastric cancer med Vyloy

FDA removes Novo's Wegovy from shortage list, marking end of semaglutide supply rout in US

Eli Lilly’s Zepbound Becomes First FDA-Approved Drug Therapy for Sleep Apnea

Axsome Aims for FDA Filing in Alzheimer’s Agitation Despite Mixed Bag of Phase 3 Data

Vertex Pharma’s Opioid Alternative Wins FDA Approval, First in a New Class of Pain Meds

'It was a good lesson': FDA reconsiders CAR-T boxed warning on secondary cancers, Peter Marks says

Bristol Myers Squibb Wins FDA Nod for Injectable Version of Blockbuster Cancer Drug

Rare Metabolic Disease That Leads to Childhood Obesity Gets Its First FDA-Approved Drug

Neurocrine Lands FDA Nod for First New Treatment in Decades for Rare Endocrine Disorder

New FDA Approval Adds Chronic Kidney Disease to Ozempic’s Label

Novo Nordisk GLP-1 Drug Meets Goals of MASH Trial, Setting Stage for FDA & EMA Filings

FDA considers 'regulatory action' for bluebird's Skysona after blood cancer reports

Novartis Nabs First FDA Nod in Rare Kidney Disease, But Apellis Pharma Is on Its Heels

Denali’s Data in Rare Enzyme Deficiency Keep It on Pace to Seek Speedy FDA Approval

FDA reaffirms decision to erase Eli Lilly's tirzepatide from shortage list, halting future flow of knockoffs

After prior rejection, Iterum nabs long-sought FDA nod for oral UTI drug Orlynvah

Pfizer Ends Sangamo Alliance With Gene Therapy for Hemophilia on Cusp of FDA Filing

Look out, Pfizer: BridgeBio scores 'best-case' FDA nod for Attruby in cardiomyopathy

FDA Approves First-in-Class GSK Antibiotic for Common Type of Urinary Tract Infection

Novo Nordisk asks FDA to prevent compounders from making copycat versions of GLP-1 star semaglutide

Syndax Pharmaceuticals Leukemia Drug Wins a First-in-Class FDA Approval

Supernus Wearable Device for Dosing Parkinson’s Drug Lands Long-Awaited FDA Approval

FDA Clears Withings’ New Blood Pressure Monitor That Allows Providers to Communicate Directly with Patients

In FDA adcomm, Lexicon gets another thumbs down for type 1 diabetes hopeful Zynquista

Novartis' Pluvicto enters FDA orbit for expansion bid as agency requests 'flexibility'

After two rejections, FDA approves Mesoblast's first-of-its-kind cell therapy

FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official Bucks Agency Staff

FDA Approval of Drug for Rare Tumors Enables SpringWorks to Challenge AstraZeneca

FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains

FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions

FDA Clears Gel That Can Stop Bleeding In Seconds

FDA Authorizes First At-Home, OTC Diagnostic Test for Syphilis

4 Things That Worry FDA Commissioner Robert Califf

Enabling Clinical Trial Innovation Through AI Regulation at FDA

Wearable Tumor-Zapping Medical Device Wins FDA Approval for Lung Cancer

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