Biopharma, FDA and Patients - Pharma Rep Focus

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

MedCity News

FEBRUARY 4, 2025

Supernus Pharmaceuticals Onapgo provides a continuous infusion of apomorphine to manage off periods experienced by Parkinsons disease patients. Approval of Onapgo comes after the FDA twice turned back applications for the drug/device combination product.

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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.

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FDA Approves First Drug for Treating Agitation in Alzheimer’s Patients

MedCity News

MAY 11, 2023

Rexulti, a drug for schizophrenia and depression, now has an additional approval for treating agitation in Alzheimer’s disease patients. The FDA decision makes the Otsuka Pharmaceutical and Lundbeck product the first drug approved for this indication.

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

MedCity News

DECEMBER 9, 2024

Results from the Phase 3 DREAMM-7 study show GSK drug Blenrep is helping multiple myeloma patients live longer compared to treatment with blockbuster Johnson & Johnson drug Darzalex. The post GSK Multiple Myeloma Drugs DREAMM Comeback Continues With Phase 3 Data at ASH appeared first on MedCity News.

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Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs

MedCity News

APRIL 8, 2024

The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products. The post Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs appeared first on MedCity News.

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FDA approval of AstraZeneca drug is first for a new group of breast cancer patients

MedCity News

AUGUST 5, 2022

Enhertu, a breast cancer drug from AstraZeneca and Daiichi Sankyo, is now FDA approved for treating patients whose tumors express low levels of the protein HER2. The decision makes the infused therapy the first targeted treatment for this new category of breast cancer patients.

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Sanofi’s FDA Nod in Hemophilia Gives Patients More Convenience, Brings Roche New Competition

MedCity News

FEBRUARY 23, 2023

FDA approval of Sanofi hemophilia A drug Altuviiio provides patients with a therapeutic option that lasts longer than most other products available, including one already marketed by the French pharma giant. Altuviiio also gives Sanofi a way to better compete against blockbuster Roche drug Hemlibra.

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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. In addition to slowing cognitive decline and disease progression, clinical trial results showed that amyloid beta plaques were reduced to the point where some patients could stop taking the infused therapy.

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Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas

MedCity News

SEPTEMBER 6, 2024

The FDA decision for Travere Therapeutics’ Filspari also expands its addressable patient population. The post Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas appeared first on MedCity News.

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FDA Says ‘No’ to Novo Nordisk’s Once-Weekly Insulin

MedCity News

JULY 12, 2024

The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news.

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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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FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer

MedCity News

APRIL 24, 2024

Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The regulatory decision for Ojemda covers a broader swath of patients than a drug combination from Novartis approved for treating this childhood cancer.

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An Attack on Patients’ Right to Informed Consent

MedCity News

MARCH 6, 2024

This case, about the claim that Merck failed to warn patients about the risk of typical femoral fracture, reaches past this suit to potentially change pharmaceutical companies’ relationship with the FDA.

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FDA Rejection Delays Regeneron From Competing With J&J, Pfizer in Multiple Myeloma

MedCity News

AUGUST 21, 2024

Regeneron Pharmaceuticals said the FDA cited no approvability concerns for its multiple myeloma drug, linvoseltamab, other than previously identified issues with a contract manufacturer. The post FDA Rejection Delays Regeneron From Competing With J&J, Pfizer in Multiple Myeloma appeared first on MedCity News.

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FDA Forms New Digital Health Advisory Committee to Cover Growing Role of Tech

MedCity News

OCTOBER 15, 2023

The FDA’s digital health advisory committee will discuss technologies such as artificial intelligence and machine learning, virtual reality, and digital therapeutics as well as topics like decentralized clinical trials and patient-generated health data. Committee member nominations are due in December.

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FDA Nod in Duchenne Helps Wider Swath of Patients With the Rare Muscle Disease

MedCity News

MARCH 22, 2024

FDA approval of Italfarmaco’s Duvyzat is the first nonsteroidal drug to pass the agency’s regulatory bar for treating this rare disease. Corticosteroids are a standard first-line treatment for Duchenne muscular dystrophy, but these drugs have many side effects.

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FDA Probes New Cases of Cancer That May Stem From Cancer Cell Therapies

MedCity News

NOVEMBER 28, 2023

CAR T-therapies for cancer are now under tighter FDA scrutiny as the agency opens an inquiry regarding reports that some patients who received these cell therapies went on to develop new cases of cancer. The FDA said benefits of these therapies still outweigh their risks, but it is evaluating the need for regulatory action.

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FDA Mulls Policy Switch on Switching Study Requirement for Biosimilars

MedCity News

JUNE 20, 2024

FDA draft guidance eliminates the requirement that biosimilars produce clinical data to show they are interchangeable with their reference drugs. Some lawmakers have said these so-called switching studies add time and expense to the development of biosimilars, delaying them from reaching patients.

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Novo Nordisk’s Diabetes Pill Rybelsus Gets FDA O.K. as First-Line Therapy

MedCity News

JANUARY 13, 2023

The FDA approved a change in Rybelsus’s label, allowing the drug to be used as an initial therapy for type 2 diabetes patients. The once-daily pill has already become a blockbuster product for Novo Nordisk.

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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.

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J&J multiple myeloma drug gets FDA nod, bringing patients an easier dosing option

MedCity News

OCTOBER 26, 2022

FDA approval of Tecvayli, from Johnson & Johnson subsidiary Janssen Biotech, makes it the newest therapy that treats multiple myeloma by targeting the cancer protein BCMA.

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Pfizer Meningococcal Vaccine Nabs FDA Nod, Offering More Convenient Dosing

MedCity News

OCTOBER 22, 2023

The FDA approved Pfizer’s Penbraya for vaccinating against five bacterial groups that can cause meningococcal disease. Pfizer already has vaccines covering those groups, but Penbraya addresses all of them in a single vaccine, making dosing easier for patients.

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GSK Gets FDA Nod for Drug Treating Anemia From Chronic Kidney Disease

MedCity News

FEBRUARY 2, 2023

The FDA approved GSK drug Jesduvroq for treating anemia in patients with chronic kidney disease. The once-daily pill is the first oral medicine to pass FDA muster in this indication, giving patients a more convenient alternative to injectable anemia therapies.

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Provention Wins FDA Approval for First Drug to Delay Type 1 Diabetes Progression

MedCity News

NOVEMBER 18, 2022

Type 1 diabetes patients now have a new therapeutic option for the autoimmune disorder. Provention Bio drug Tzeild has received FDA approval for delaying the onset of the most severe stage of this chronic disease.

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Verona Pharma Drug With Dual Mechanism Lands FDA Approval in COPD

MedCity News

JUNE 27, 2024

Verona Pharma’s COPD drug Ohtuvayre is a single small molecule that blocks two targets to bring patients both bronchodilation and anti-inflammatory effects. The post Verona Pharma Drug With Dual Mechanism Lands FDA Approval in COPD appeared first on MedCity News.

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Amicus Therapeutics Rare Disease Combo Therapy Wins Long-Awaited FDA Nod

MedCity News

SEPTEMBER 28, 2023

The FDA has approved an Amicus Therapeutics combination treatment for patients inadequately served by the Sanofi products. Sanofi dominates the market for therapies that treat Pompe disease, a rare enzyme deficiency.

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Eli Lilly Moves Closer to Bringing Diabetes Patients a Once-Weekly Insulin Alternative

MedCity News

SEPTEMBER 5, 2024

Positive preliminary results for Eli Lilly’s efsitora alfa continue to build the case for this once-weekly insulin in type 2 diabetes patients. Lilly is trying to catch up to Novo Nordisk’s once weekly insulin icodec, which is commercially available in several markets around the world but is not yet approved by the FDA.

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Biogen bolsters case for ALS drug under FDA review with new published data

MedCity News

SEPTEMBER 22, 2022

A Biogen drug designed for a genetically defined form of amyotrophic lateral sclerosis led to patient improvement at a 12- month analysis, according to data now published in the New England Journal of Medicine.

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FDA Reconsideration Leads to Approval of Takeda Drug for Rare Esophagus Disorder

MedCity News

FEBRUARY 12, 2024

FDA approval of Takeda Pharmaceutical drug Eohilia introduces a new therapeutic option for patients with eosinophilic esophagitis, inflammation of the esophagus that causes swallowing difficulty. It will compete against Dupixent, a Sanofi and Regeneron Pharmaceuticals drug already approved for this disorder.

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Chiesi Wins FDA Approval for First Drug to Treat Ultra-Rare Enzyme Deficiency

MedCity News

FEBRUARY 17, 2023

Chiesi drug Lamzede is an engineered version of an enzyme that’s lacking in patients with the rare disease alpha-mannosidosis. FDA approval of the Chiesi drug comes about five years after European regulators authorized the product.

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FDA Approval of Eisai Alzheimer’s Drug Bears Imprint of Aduhelm Review

MedCity News

JANUARY 8, 2023

Eisai Alzheimer’s disease drug Leqembi is now approved for the treatment of patients with an early form of the memory-robbing disease. In granting the antibody accelerated approval, the FDA employed reasoning that was the also basis for the controversial speedy regulatory nod for Biogen’s drug, Aduhelm.

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FDA turns down Acadia Pharma drug for Alzheimer’s psychosis; new trial needed

MedCity News

AUGUST 7, 2022

Acadia Pharmaceuticals drug Nuplazid failed to win FDA approval for the treatment of psychosis in Alzheimer’s disease patients. The regulator said that the data submitted were not from an adequate and well-controlled study and the company must run another clinical trial.

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New Hemophilia Data Lead FDA to Delay Decision for BioMarin Gene Therapy

MedCity News

MARCH 7, 2023

BioMarin Pharmaceutical’s submission of additional data for patients treated with its hemophilia A gene therapy, Roctavian, mean that the FDA will push out a regulatory decision to early summer. But it could be worth the wait as analysts anticipate FDA approval and project Roctavian becoming one of BioMarin’s biggest products.

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Sarepta Gene Therapy Misses in Phase 3; Prospects Now Rely on FDA Flexibility

MedCity News

OCTOBER 31, 2023

Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy fell short of its main Phase 3 goal, but the firm contends the full body of evidence supports expanding the therapy’s label to all patients who have the muscle-wasting disease.

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Cardiac Complication Leads FDA to Place Foghorn Cancer Drug Under Partial Hold

MedCity News

APRIL 24, 2023

A clinical trial for a Foghorn Therapeutics cancer drug is under a partial FDA hold after a patient in the early-stage study developed a cardiovascular complication. It’s the biotech’s second partial hold in the past year.

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With FDA Nod for Colorectal Cancer Screening, How Much Market Share Can Guardant’s Blood Test Get?

MedCity News

JULY 30, 2024

Guardant Health’s Shield, a liquid biopsy that screens for colorectal cancer by analyzing a patient blood sample, will compete against stool-based tests already established in the market. The post With FDA Nod for Colorectal Cancer Screening, How Much Market Share Can Guardant’s Blood Test Get?

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FDA Rejects Eli Lilly Alzheimer’s Drug, Asks for More Data From Ongoing Study

MedCity News

JANUARY 19, 2023

The company said the FDA is asking for data from more patients—results that must come from a larger study that’s underway but won’t report data until later this year. Eli Lilly’s accelerated approval application for its Alzheimer’s disease drug has fallen short.

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After FDA Miss in Diabetes, Lexicon Lands Long-Awaited Approval in Heart Failure

MedCity News

MAY 30, 2023

Lexicon Pharmaceuticals drug Inpefa is now FDA-approved for heart failure. Inpefa is third in its class, but the biotech says its pill can reach a specific subset of patients, enabling it to stand apart from rival medicines from AstraZeneca and partners Eli Lilly and Boehringer Ingelheim.

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InflaRx Covid-19 Drug Welcomes an FDA Win; Pardes Bio Throws In the Towel

MedCity News

APRIL 5, 2023

The FDA granted emergency use authorization to an InflaRx antibody drug that treats hospitalized Covid-19 patients. But Pardes Bioscience’s coronavirus journey is ending following the Phase 2 failure of an antiviral that was expected to compete with Pfizer’s Paxlovid.

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FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

MedCity News

JANUARY 23, 2024

Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply.

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Bristol Myers Squibb Wins FDA Approval for Lung Cancer Drug From $4B Deal

MedCity News

NOVEMBER 16, 2023

FDA approval of Bristol Myers Squibb’s Augtyro covers treatment of patients whose non-small cell lung cancer is driven by the rare ROS1 mutation. The molecule comes from BMS’s 2022 acquisition of Turning Point Therapeutics.

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UCB Muscle Disease Drug Wins FDA Nod on Heels of Rival’s Regulatory Approval

MedCity News

JUNE 27, 2023

The FDA approved UCB’s Rystiggo for treating generalized myasthenia gravis. Drugs are already available for the rare neuromuscular disorder, but Rystiggo’s approval includes treatment of a subset of patients not addressed by other products.

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

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

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

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

FDA Approves First Drug for Treating Agitation in Alzheimer’s Patients

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

Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs

FDA approval of AstraZeneca drug is first for a new group of breast cancer patients

Sanofi’s FDA Nod in Hemophilia Gives Patients More Convenience, Brings Roche New Competition

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

Full FDA Approval of Travere’s Kidney Drug Stiffens Competition With Novartis, Calliditas

FDA Says ‘No’ to Novo Nordisk’s Once-Weekly Insulin

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

FDA Drug Approval Marks a New Day for Treating Pediatric Brain Cancer

An Attack on Patients’ Right to Informed Consent

FDA Rejection Delays Regeneron From Competing With J&J, Pfizer in Multiple Myeloma

FDA Forms New Digital Health Advisory Committee to Cover Growing Role of Tech

FDA Nod in Duchenne Helps Wider Swath of Patients With the Rare Muscle Disease

FDA Probes New Cases of Cancer That May Stem From Cancer Cell Therapies

FDA Mulls Policy Switch on Switching Study Requirement for Biosimilars

Novo Nordisk’s Diabetes Pill Rybelsus Gets FDA O.K. as First-Line Therapy

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

J&J multiple myeloma drug gets FDA nod, bringing patients an easier dosing option

Pfizer Meningococcal Vaccine Nabs FDA Nod, Offering More Convenient Dosing

GSK Gets FDA Nod for Drug Treating Anemia From Chronic Kidney Disease

Provention Wins FDA Approval for First Drug to Delay Type 1 Diabetes Progression

Verona Pharma Drug With Dual Mechanism Lands FDA Approval in COPD

Amicus Therapeutics Rare Disease Combo Therapy Wins Long-Awaited FDA Nod

Eli Lilly Moves Closer to Bringing Diabetes Patients a Once-Weekly Insulin Alternative

Biogen bolsters case for ALS drug under FDA review with new published data

FDA Reconsideration Leads to Approval of Takeda Drug for Rare Esophagus Disorder

Chiesi Wins FDA Approval for First Drug to Treat Ultra-Rare Enzyme Deficiency

FDA Approval of Eisai Alzheimer’s Drug Bears Imprint of Aduhelm Review

FDA turns down Acadia Pharma drug for Alzheimer’s psychosis; new trial needed

New Hemophilia Data Lead FDA to Delay Decision for BioMarin Gene Therapy

Sarepta Gene Therapy Misses in Phase 3; Prospects Now Rely on FDA Flexibility

Cardiac Complication Leads FDA to Place Foghorn Cancer Drug Under Partial Hold

With FDA Nod for Colorectal Cancer Screening, How Much Market Share Can Guardant’s Blood Test Get?

FDA Rejects Eli Lilly Alzheimer’s Drug, Asks for More Data From Ongoing Study

After FDA Miss in Diabetes, Lexicon Lands Long-Awaited Approval in Heart Failure

InflaRx Covid-19 Drug Welcomes an FDA Win; Pardes Bio Throws In the Towel

FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

Bristol Myers Squibb Wins FDA Approval for Lung Cancer Drug From $4B Deal

UCB Muscle Disease Drug Wins FDA Nod on Heels of Rival’s Regulatory Approval

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