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Biopharma in 2025: Outlook for Obesity Meds, Drug Prices, Regulation & More

MedCity News

JANUARY 8, 2025

The post Biopharma in 2025: Outlook for Obesity Meds, Drug Prices, Regulation & More appeared first on MedCity News. Metabolic medicines dominated life sciences headlines in 2024, a trend expected to continue into the new year.

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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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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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‘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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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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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.

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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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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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Cancer Biotech ArriVent Lands an ADC for GI Malignancies and Makes Best-in-Class Claim

MedCity News

JANUARY 22, 2025

ArriVent Biopharma claims best-in-class potential in gastrointestinal cancers for its new asset, but its not specifying the class. a hot target for GI cancer drug research that recently welcomed its first FDA-approved therapy and is in pursuit by several companies. Its possible the Phase 1-ready drug goes after claudin 18.2,

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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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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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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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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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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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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 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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FDA approves first MASH drug: Madrigal's Rezdiffra breaks ground in notorious biopharma graveyard

Fierce Pharma

MARCH 11, 2024

The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended, as the FDA has approved the first drug for the fatty liver disease. | The FDA has approved Madrigal's resmetirom under the brand name Rezdiffra as the first drug for the fatty liver disease.

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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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Amgen's request for full approval of Lumakras in lung cancer denied by FDA

Fierce Pharma

DECEMBER 27, 2023

Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California biopharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod.

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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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FTC Sees Red Over Alleged Misuse of FDA Orange Book, Puts 10 Pharmas on Notice

MedCity News

NOVEMBER 7, 2023

The Federal Trade Commission says more than 100 patents from 10 biopharma companies are improperly listed in the FDA’s official publication of approved products. Such listings delay generic competition, which reduces consumer choice and keeps prices high, the regulator said.

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RFK Jr. could 'cost lives in this country' if he pursues changes to US vaccine policy, Gottlieb says

Fierce Pharma

DECEMBER 2, 2024

Department of Health and Human Services immediately sent waves of speculation swirling throughout the biopharma industry. | The former FDA Commissioner pointed to the threat of measles if vaccination rates were to decline by 5%. Kennedy Jr.’s s appointment last month to lead the U.S.

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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.

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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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Biogen, Sage Therapeutics Drop Plans to Develop Partnered Drug in Major Depressive Disorder

MedCity News

OCTOBER 30, 2024

The FDA had asked Biogen and Sage Therapeutics to provide more clinical data supporting Zurzuvae in major depressive disorder.

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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.

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Lawmakers urge FDA to investigate clinical trials run in tandem with China's military

Fierce Pharma

AUGUST 20, 2024

As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China's biopharma ecosystem. |

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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.

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FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

MedCity News

APRIL 1, 2024

The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. The post FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

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Ipsen Joins the ADC Chase, Licensing Phase 1-Ready Asset for Novel Cancer Target

MedCity News

APRIL 2, 2024

Ipsen is acquiring global rights to a Sutro Biopharma antibody drug conjugate for a target that is not yet hit by any FDA-approved drugs. Merck is among the companies pursuing this target, but Sutro claims its ADC could be first and best in this class.

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FDA Approves Moderna RSV Vaccine, an mRNA Alternative to GSK and Pfizer Products

MedCity News

MAY 31, 2024

Moderna’s mResvia is now the third FDA-approved RSV vaccine and the first one based on mRNA technology. It will compete for market share against RSV shots from GSK and Pfizer that won their FDA nods last year. The post FDA Approves Moderna RSV Vaccine, an mRNA Alternative to GSK and Pfizer Products appeared first on MedCity News.

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FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery

MedCity News

APRIL 23, 2024

ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The post FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery appeared first on MedCity News. The novel immunotherapy works by sparking activity from three types of immune cells.

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FDA Awards Accelerated Approval to Gilead Sciences Drug for Rare Liver Disease

MedCity News

AUGUST 14, 2024

Livdelzi is now FDA-approved for treating the rare liver disease primary biliary cholangitis. The post FDA Awards Accelerated Approval to Gilead Sciences Drug for Rare Liver Disease appeared first on MedCity News. Gilead Sciences added the drug to its pipeline via the $4.3 billion acquisition of CymaBay Therapeutics earlier this year.

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FDA Approval Makes a Zevra Drug the First Therapy for Rare and Fatal Metabolic Disease

MedCity News

SEPTEMBER 20, 2024

Zevra Therapeutics drug Miplyffa is now FDA approved for Niemann-Pick disease type C, a lysosomal storage disorder. The affirmative regulatory decision took into account additional clinical data generated since the FDA turned down a submission for the drug in 2021.

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GSK Multiple Myeloma Drug’s DREAMM Comeback Continues With Phase 3 Data at ASH

MedCity News

DECEMBER 9, 2024

The data, presented Monday during the annual meeting of the American Society of Hematology, are part of a submission now under FDA review that could lead to Blenreps return to the market. The post GSK Multiple Myeloma Drugs DREAMM Comeback Continues With Phase 3 Data at ASH appeared first on MedCity News.

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Amgen Drug for Aggressive Type of Lung Cancer Wins Accelerated FDA Approval

MedCity News

MAY 17, 2024

Amgen’s Imdelltra has FDA approval in extensive-stage small cell lung cancer, making it the first bispecific T cell engager approved for treating this type of cancer. The post Amgen Drug for Aggressive Type of Lung Cancer Wins Accelerated FDA Approval appeared first on MedCity News.

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Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi

MedCity News

JULY 2, 2024

Eli Lilly’s Kisunla is now FDA approved for treating patients in the early stages of Alzheimer’s disease. The post Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi appeared first on MedCity News.

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Biopharma in 2025: Outlook for Obesity Meds, Drug Prices, Regulation & More

FDA Takes Step Toward Removal of Ineffective Decongestants From the Market

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

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

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

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

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

Cancer Biotech ArriVent Lands an ADC for GI Malignancies and Makes Best-in-Class Claim

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

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

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

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

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

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 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

FDA approves first MASH drug: Madrigal's Rezdiffra breaks ground in notorious biopharma graveyard

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

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

Amgen's request for full approval of Lumakras in lung cancer denied by FDA

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

FTC Sees Red Over Alleged Misuse of FDA Orange Book, Puts 10 Pharmas on Notice

RFK Jr. could 'cost lives in this country' if he pursues changes to US vaccine policy, Gottlieb says

FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions

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

Biogen, Sage Therapeutics Drop Plans to Develop Partnered Drug in Major Depressive Disorder

Enabling Clinical Trial Innovation Through AI Regulation at FDA

Lawmakers urge FDA to investigate clinical trials run in tandem with China's military

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

FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

Ipsen Joins the ADC Chase, Licensing Phase 1-Ready Asset for Novel Cancer Target

FDA Approves Moderna RSV Vaccine, an mRNA Alternative to GSK and Pfizer Products

FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery

FDA Awards Accelerated Approval to Gilead Sciences Drug for Rare Liver Disease

FDA Approval Makes a Zevra Drug the First Therapy for Rare and Fatal Metabolic Disease

GSK Multiple Myeloma Drug’s DREAMM Comeback Continues With Phase 3 Data at ASH

Amgen Drug for Aggressive Type of Lung Cancer Wins Accelerated FDA Approval

Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi

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