FDA and Pharma - Pharma Rep Focus

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

MedCity News

NOVEMBER 25, 2024

BridgeBio Pharma claims its drug, Attruby, has an edge over a Pfizer drug as a treatment for cardiomyopathy caused by transthyretin-mediated amyloidosis. 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.

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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.

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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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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.

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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

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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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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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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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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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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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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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Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency

MedCity News

AUGUST 12, 2024

FDA approval of Ascendis Pharma’s Yorvipath is just in time for patients with hypoparathyroidism as Takeda Pharmaceutical will soon stop making the only drug therapy for the rare disorder. The post Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency appeared first on MedCity News.

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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 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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FDA Approval of Alopecia Drug Positions Sun Pharma to Compete With Eli Lilly, Pfizer

MedCity News

JULY 28, 2024

Leqselvi is now FDA approved for treating severe alopecia areata. Sun Pharma added the oral drug to its pipeline via the $576 million acquisition of Concert Pharmaceuticals last year. The post FDA Approval of Alopecia Drug Positions Sun Pharma to Compete With Eli Lilly, Pfizer appeared first on MedCity News.

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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.

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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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Novo Nordisk Commits $285M to Ascendis to Kick Off Alliance on Longer-Acting GLP-1 Drugs

MedCity News

NOVEMBER 4, 2024

This product candidate will be developed with Ascendis Pharma technology that has already yielded two FDA-approved products with longer dosing intervals. The Novo Nordisk/Ascendis partnership’s lead program is once-monthly injectable semaglutide for type 2 diabetes and obesity.

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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.

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Verona Pharma Drug With Dual Mechanism Lands FDA Approval in COPD

MedCity News

JUNE 27, 2024

The post Verona Pharma Drug With Dual Mechanism Lands FDA Approval in COPD appeared first on MedCity News. Verona executives contend their inhalable drug has key advantages over the last novel COPD medication, the orally administered roflumilast.

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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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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.

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Astellas Pharma Lands a First-in-Class Drug Approval in Rare Gastrointestinal Cancer

MedCity News

OCTOBER 21, 2024

The FDA approved Astellas’s Vyloy as a treatment for advanced cases of gastric or gastroesophageal junction (GEJ) adenocarcinoma positive for a protein called claudin 18.2. It’s the first FDA-approved therapy for this target.

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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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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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A First for Fatty Liver: FDA Approves Madrigal Pharma NASH Drug

MedCity News

MARCH 14, 2024

The FDA has approved Madrigal Pharmaceuticals drug Rezdiffra as a treatment for the fatty liver disease NASH (also called MASH). It’s the first treatment for the chronic condition, which has been growing in prevalence.

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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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New Eli Lilly Eczema Drug Brings Competition and Dosing Edge Versus Sanofi, LEO Pharma Meds

MedCity News

SEPTEMBER 16, 2024

Eli Lilly drug Ebglyss is now FDA-approved for atopic dermatitis, an inflammatory skin disorder also known as eczema. The post New Eli Lilly Eczema Drug Brings Competition and Dosing Edge Versus Sanofi, LEO Pharma Meds appeared first on MedCity News. The biologic drug came from Lilly’s $1.1 billion acquisition of Dermira in 2020.

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Seeing a Better Way for Eye Drug R&D, Character Bio Lands $93M for Two Trials in Dry AMD

MedCity News

MARCH 25, 2025

Apellis Pharmaceuticals and Astellas Pharma have the first two FDA-approved therapies for geographic atrophy, but Character Biosciences claims its approach could be best in class for treating this advanced form of dry age-related macular degeneration.

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Highly Anticipated FDA Decision Comes Just in Time for Back-to-School Season

MedCity News

SEPTEMBER 2, 2024

FDA approval of neffy, a nasal spray formulation of epinephrine, clears the way for ARS Pharma to launch the product in time for the new school year. In other recent regulatory news, the FDA approved updated Covid-19 vaccines as well as a new mpox vaccine.

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FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine

MedCity News

SEPTEMBER 20, 2023

Though this spray won the backing of an FDA advisory committee, the agency is now requiring that ARS Pharma run another study to support a regulatory submission. ARS Pharmaceuticals frames its intranasal epinephrine spray as a needle-free alternative to products such as EpiPen.

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FDA Approval of Bristol Myers Drug Makes It the First Novel Schizophrenia Med in Decades

MedCity News

SEPTEMBER 27, 2024

The drug came from the pharma giant’s $14 billion acquisition of Karuna Therapeutics. The post FDA Approval of Bristol Myers Drug Makes It the First Novel Schizophrenia Med in Decades appeared first on MedCity News.

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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.

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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.

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Heartburn Drug from Phathom Pharma Expands Its Approval to Cover More GERD Patients

MedCity News

JULY 18, 2024

Expanded FDA approval of Phathom Pharmaceuticals drug Voquezna now includes patients with non-erosive gastroesophageal reflux disease (GERD). The post Heartburn Drug from Phathom Pharma Expands Its Approval to Cover More GERD Patients appeared first on MedCity News. Phathom licensed its flagship product from Takeda Pharmaceutical.

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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.

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

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

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

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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

FDA Takes Step Toward Removal of Ineffective Decongestants From the Market

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

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

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

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

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

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

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

Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency

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

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

FDA Approval of Alopecia Drug Positions Sun Pharma to Compete With Eli Lilly, Pfizer

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

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

Novo Nordisk Commits $285M to Ascendis to Kick Off Alliance on Longer-Acting GLP-1 Drugs

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

Verona Pharma Drug With Dual Mechanism Lands FDA Approval in COPD

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

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

Astellas Pharma Lands a First-in-Class Drug Approval in Rare Gastrointestinal Cancer

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

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

A First for Fatty Liver: FDA Approves Madrigal Pharma NASH Drug

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

New Eli Lilly Eczema Drug Brings Competition and Dosing Edge Versus Sanofi, LEO Pharma Meds

Seeing a Better Way for Eye Drug R&D, Character Bio Lands $93M for Two Trials in Dry AMD

Highly Anticipated FDA Decision Comes Just in Time for Back-to-School Season

FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine

FDA Approval of Bristol Myers Drug Makes It the First Novel Schizophrenia Med in Decades

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

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

Heartburn Drug from Phathom Pharma Expands Its Approval to Cover More GERD Patients

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

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