FDA and Medicine - Pharma Rep Focus

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. Use of this ingredient in cold and allergy medicines grew after a federal law required that pseudoephedrine-containing products be kept behind pharmacy counters.

FDA

FDA Marketing Medicine Biopharma

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

MedCity News

DECEMBER 22, 2024

The new approval gives the Eli Lilly medicine the opportunity to become a blockbuster seller in yet another indication. The post Eli Lillys Zepbound Becomes First FDA-Approved Drug Therapy for Sleep Apnea appeared first on MedCity News.

FDA

FDA Medicine Biopharma Pharma

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

FDA

FDA Medicine

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 twice-daily pill is the first in a new class of medicines that block a key pathway in the peripheral nervous system.

FDA

FDA Medicine Pharma Pharmaceutical

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.

FDA

FDA Medicine Patients

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.

FDA

FDA Medicine

What’s Next for Psychedelic Medicines?

MedCity News

OCTOBER 30, 2024

After the FDA delayed the approval of MDMA-assisted therapy for PTSD, there’s still a way forward for psychedelic medicines, experts said at HLTH. The post What’s Next for Psychedelic Medicines? appeared first on MedCity News.

Medicine

Medicine FDA

Kura Oncology Gets $330M to Kick Off Global Leukemia Drug Pact With Kyowa Kirin

MedCity News

NOVEMBER 21, 2024

Ziftomenib is in the same class of medicines as Syndax Pharmaceuticals’ Revuforj, which won FDA approval last week. Kura Oncology already had a broad development plan for ziftomenib in leukemias, but the agreement with Kyowa Kirin provides the cash to execute it and a partner to commercialize the drug globally.

Medicine

Medicine 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

FDA Medicine Biopharma Pharma

Geron Drug Lands a First-in-Class FDA Approval in Type of Blood Cancer

MedCity News

JUNE 9, 2024

Geron Corporation’s Rytelo is now FDA approved for treating anemia caused by myelodysplastic syndromes. The new drug will compete against Reblozyl, a blockbuster Bristol Myers Squibb medicine. The post Geron Drug Lands a First-in-Class FDA Approval in Type of Blood Cancer appeared first on MedCity News.

FDA

FDA Medicine Biopharma Pharma

FDA proposes cell and gene therapy site tours to help regulators learn from industry

Fierce Pharma

JULY 15, 2024

It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. | It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years.

FDA

FDA Manufacturing Medicine

The FDA might yank cold medicines from shelves — and that could be just the beginning

PharmaVoice

OCTOBER 17, 2023

Phenylephrine’s future is up in the air with an FDA committee saying it’s not effective and a class action lawsuit alleging false advertising. What comes next could have big repercussions.

FDA

FDA Medicine

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.

FDA

FDA Medicine Patients Biopharma

ESC 2024: UK's George Medicines posts positive results for triple-combo blood pressure drug on heels of FDA submission

Fierce Pharma

AUGUST 30, 2024

ESC 2024: UK's George Medicines posts positive results for triple-combo blood pressure drug on heels of FDA submission fkansteiner Fri, 08/30/2024 - 15:54

Medicine

Medicine FDA

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.

FDA

FDA Medicine Patients Biopharma

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

MedCity News

JANUARY 8, 2025

Metabolic medicines dominated life sciences headlines in 2024, a trend expected to continue into the new year. Other things to look for include more widespread adoption of artificial intelligence technologies and the IPO markets return to normal levels.

Biopharma

Biopharma Medicine Marketing FDA

FDA issues first recommendations on AI for drug development

European Pharmaceutical Review

JANUARY 7, 2025

The US Food and Drug Administration (FDA) has for the first time, issued draft guidance on using artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product. The guidelines address the safety, effectiveness or quality of these medicines.

Food and Drug Administration

Food and Drug Administration FDA Medical Food

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.

FDA

FDA Medicine Pharmaceutical Patients

'Most' cancer meds approved under FDA's accelerated pathway couldn't prove survival benefit after 5 years: study

Fierce Pharma

APRIL 8, 2024

One hallmark of the FDA's accelerated approval pathway is the requirement that medicines prove their benefits in confirmatory trials.

FDA

FDA Medicine

Vertex, CRISPR score landmark FDA approval for sickle cell disease gene therapy Casgevy

Fierce Pharma

DECEMBER 8, 2023

| Vertex Pharmaceuticals and CRISPR Therapeutics have won an historic FDA approval for their sickle cell disease gene therapy Casgevy. The transformational treatment is a potential cure for the debilitating and life-threatening disease which affects more than 100,000 in the United States, most of them Black.

FDA

FDA Medicine Pharmaceutical

FDA approves Roche, Novartis' Xolair to prevent severe outcomes from common food allergies

Fierce Pharma

FEBRUARY 16, 2024

The FDA has blessed Roche and Novartis’ Xolair as the first medicine to reduce allergic reactions that can occur with accidental exposure to certain foods. . | People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades.

Food

Food FDA Medicine Marketing

5 years after FDA approval, CAR-T treatment looks like the future of medicine

MedCity News

OCTOBER 28, 2022

CAR-T has become increasingly recognized as an exciting and potentially paradigm-shifting treatment in the past five years. In fact, more than 10,000 patients have undergone this new treatment for certain types of leukemia, lymphoma. and multiple myeloma.

Medicine

Medicine FDA Patients Biopharma

Orexo, leveraging drug delivery tech, seeks FDA approval of nasal high-dose opioid rescue medicine

Fierce Pharma

FEBRUARY 7, 2023

Orexo, leveraging drug delivery tech, seeks FDA approval of nasal high-dose opioid rescue medicine ntaylor Tue, 02/07/2023 - 08:18

Medicine

Medicine FDA

FDA signs off on new uses for Astellas and Pfizer's Xtandi, Merck's Keytruda

Fierce Pharma

NOVEMBER 17, 2023

The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. | The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi.

FDA

FDA Medicine

FDA Tells Verve What to Do to Get Hold Lifted From Gene-Editing Therapy

MedCity News

DECEMBER 5, 2022

Verve Therapeutics received the formal FDA letter outlining what the agency wants to see before it lifts the clinical hold placed on the biotech’s gene-editing therapy.

FDA

FDA Medicine Biopharma Pharma

FDA proposes ban on main ingredient in many OTC decongestants

Fierce Pharma

NOVEMBER 8, 2024

Common oral medicines that have been used for decades as decongestants such as Sudafed, NyQuil and Benadryl may soon be cleared from shelves as the FDA has

FDA

FDA Medicine

FDA approves first-in-class oral antibiotic

European Pharmaceutical Review

MARCH 26, 2025

The US Food and Drug Administration (FDA) has approved Blujepa ( gepotidacin ) antibiotic for uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients aged 12 years old and over. The post FDA approves first-in-class oral antibiotic appeared first on European Pharmaceutical Review.

Food and Drug Administration

Food and Drug Administration FDA Medicine Food

Johnson & Johnson's Aurlumyn scores first FDA approval to treat severe frostbite

Fierce Pharma

FEBRUARY 14, 2024

The FDA has approved the first medicine for severe frostbite. Over the last month, for those watching HBO’s macabre “True Detective Night Country”—a TV series set in a harsh, sunless winter in a fictional Alaskan town—a continual theme is frostbite. |

FDA

FDA Medicine

Cell therapy bigwigs endorse CAR-T in Nature Medicine article amid FDA safety probe

Fierce Pharma

JANUARY 6, 2024

A group of cell therapy experts, including CAR-T pioneers Drs. Bruce Levine and Carl June, wrote in support of continued use of CAR-T therapy.

Safety

Safety Medicine FDA

UCB's psoriasis drug application overcomes manufacturing hurdle but hits another FDA delay

Fierce Pharma

SEPTEMBER 20, 2023

UCB had previously expected an FDA decision during the first half of the year after suffering a prior rejection on its medicine. After a manufacturing-related complete response letter held up the U.S. | But now the company warned a decision will likely be delayed past the third quarter.

Manufacturing

Manufacturing FDA Medicine

New FDA head needs to examine the accelerated approval program

World of DTC Marketing

OCTOBER 21, 2021

SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5 appeared first on World of DTC Marketing.com.

FDA

FDA Insurance Prescription Medicine

Roche scores FDA nod for prefilled syringe version of Vabysmo, easing its administration

Fierce Pharma

JULY 8, 2024

Roche has taken another step in its advancement of the blockbuster medicine, scoring an FDA nod to provide it in a prefilled syringe. . | Since Roche gained approval for its eye disease medication Vabysmo in 2022, it has stormed a market dominated by Regeneron and Bayer’s Eylea.

FDA

FDA Doctors Medicine Medical

Roche files patent suit to fend off potential Evrysdi generics from Zydus, Natco

Fierce Pharma

NOVEMBER 20, 2024

Roche's spinal muscular atrophy (SMA) medicine Evrysdi only gained its FDA approval in 2020, but generics companies are already eying the blockbuster as a potential target. | The spinal muscular atrophy drug is a growth driver for the Swiss pharma giant, prompting the company to prioritize its defense against potential generics.

Medicine

Medicine FDA Pharma

As FDA probes CAR-T safety, expert meeting for Bristol's Abecma could serve as key guidepost

Fierce Pharma

NOVEMBER 29, 2023

The revelation of an FDA investigation< | As industry watchers deliberate the implications from the FDA's investigation into secondary cancer risks from CAR-T medicines, an upcoming expert meeting could offer precious clarity from drug regulators.

FDA

FDA Safety Medicine

Project seeks to chart regulatory paths for digital products

MedCity News

JUNE 16, 2022

The nonprofit Digital Medicine Society is partnering with the likes of Google and the FDA to develop a free resource designed to help digital health startups navigate the regulatory process.

Medicine

Medicine FDA

Neuro Drug Passed Up by Biogen Posts Positive Data for Ionis, Setting Stage for Phase 3 Test

MedCity News

JULY 22, 2024

Ionis Pharmaceuticals is looking ahead to a Phase 3 study for an antisense medicine it is developing to treat Angelman syndrome, a rare neurodevelopmental disorder with no FDA-approved therapies. Its main competition is an Ultragenyx Pharmaceutical drug set to begin pivotal testing later this year.

Competition

Competition Pharmaceutical Medicine FDA

Amgen Osteoporosis Drug Prolia Is Hit With FDA’s Strictest Warning

MedCity News

JANUARY 21, 2024

The FDA said Amgen’s Prolia may lead to low levels of calcium, or hypocalcemia. The osteoporosis drug’s black box warning follows an FDA review of Centers for Medicare & Medicaid Services studies that found Prolia led to a significant increase in the risk of severe hypocalcemia compared to treatment with an older class of medicines.

FDA

FDA Medicine Leads Biopharma

Study finds no link between Novo Nordisk’s GLP-1 drugs and suicidal ideation

Fierce Pharma

JANUARY 5, 2024

Three days after the FDA included Novo Nordisk’s semaglutide treatments Ozempic and Wegovy on a list of medicines that it would monitor for side effects—one of them suicide ideation—a study of medi | Three days after the FDA included Novo Nordisk’s semaglutide treatments Ozempic and Wegovy on a list of medicines that it would monitor for side effects—one (..)

Side effects

Side effects Medicine FDA Medical

Drug companies know how to play the FDA drug approval process

World of DTC Marketing

JULY 13, 2021

SUMMARY: The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs. The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process. Drug companies know how to play the system. Can we make sense of this? Maybe they should.

FDA

FDA Medicine Healthcare Healthcare

KRAS crisis? FDA will gather advisers to weigh full approval for Amgen's Lumakras

Fierce Pharma

AUGUST 21, 2023

The FDA will hold an advisory committee meeting to discuss confirmatory trial data for Amgen's Lumakras in KRAS-mutated lung cancer. This comes after a bumpy stretch for the medicine since its debut in 2021. First came doubts about the combinability of Amgen’s Lumakras with a standard PD-1 inhibitor. |

FDA

FDA Medicine

Base-Editing Biotech Beam Restructures, Narrowing Pipeline & Cutting 20% of Staff

MedCity News

OCTOBER 19, 2023

Sickle cell disease is among the Beam Therapeutics programs spared, and here the company needs to show differentiation from genetic medicines under FDA review from Vertex Pharmaceuticals and Bluebird Bio. Meanwhile, Beam aims to find partners for its research in allogeneic cancer cell therapies and hepatitis B.

Medicine

Medicine FDA Pharmaceutical Biopharma

Ionis Posts Trial Data in Rare Disease That Position It to Finally Set Out on Its Own

MedCity News

SEPTEMBER 26, 2023

Ionis Pharmaceuticals’ olezarsen has Phase 3 results showing the therapy handily beat a placebo at reducing fat levels in the blood due to a rare, inherited metabolic disorder with no FDA-approved drugs. Ionis plans early 2024 submissions for what could become the first medicine it commercializes without a partner.

Medicine

Medicine Pharmaceutical FDA Biopharma

Otsuka Commits $800M in M&A Deal Bringing a Phase 3-Ready Metabolic Disorder Drug

MedCity News

AUGUST 1, 2024

Jnana’s drug could provide an alternative to two FDA-approved PKU medicines from BioMarin Pharmaceutical. Otsuka Pharmaceutical is acquiring Jnana Therapeutics, whose lead drug is a potential treatment for the rare metabolic disorder phenylketonuria (PKU).

Pharmaceutical

Pharmaceutical Medicine FDA Leads

J&J, Legend's Carvykti bid for earlier multiple myeloma use will face FDA adcomm

Fierce Pharma

JANUARY 23, 2024

Early evidence showing Carvykti’s potential to prolong patients’ lives in an earlier multiple myeloma setting didn’t save Johnson & Johnson and Legend Biotech’s CAR-T medicine from a public int | Early evidence showing the drug's potential to prolong patients' lives didn't save Johnson & Johnson and Legend Biotech's Carvykti (..)

FDA

FDA Medicine Patients

FDA Takes Step Toward Removal of Ineffective Decongestants From the Market

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

Trending Sources

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

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

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

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

What’s Next for Psychedelic Medicines?

Kura Oncology Gets $330M to Kick Off Global Leukemia Drug Pact With Kyowa Kirin

FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions

Geron Drug Lands a First-in-Class FDA Approval in Type of Blood Cancer

FDA proposes cell and gene therapy site tours to help regulators learn from industry

The FDA might yank cold medicines from shelves — and that could be just the beginning

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

ESC 2024: UK's George Medicines posts positive results for triple-combo blood pressure drug on heels of FDA submission

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

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

FDA issues first recommendations on AI for drug development

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

'Most' cancer meds approved under FDA's accelerated pathway couldn't prove survival benefit after 5 years: study

Vertex, CRISPR score landmark FDA approval for sickle cell disease gene therapy Casgevy

FDA approves Roche, Novartis' Xolair to prevent severe outcomes from common food allergies

5 years after FDA approval, CAR-T treatment looks like the future of medicine

Orexo, leveraging drug delivery tech, seeks FDA approval of nasal high-dose opioid rescue medicine

FDA signs off on new uses for Astellas and Pfizer's Xtandi, Merck's Keytruda

FDA Tells Verve What to Do to Get Hold Lifted From Gene-Editing Therapy

FDA proposes ban on main ingredient in many OTC decongestants

FDA approves first-in-class oral antibiotic

Johnson & Johnson's Aurlumyn scores first FDA approval to treat severe frostbite

Cell therapy bigwigs endorse CAR-T in Nature Medicine article amid FDA safety probe

UCB's psoriasis drug application overcomes manufacturing hurdle but hits another FDA delay

New FDA head needs to examine the accelerated approval program

Roche scores FDA nod for prefilled syringe version of Vabysmo, easing its administration

Roche files patent suit to fend off potential Evrysdi generics from Zydus, Natco

As FDA probes CAR-T safety, expert meeting for Bristol's Abecma could serve as key guidepost

Project seeks to chart regulatory paths for digital products

Neuro Drug Passed Up by Biogen Posts Positive Data for Ionis, Setting Stage for Phase 3 Test

Amgen Osteoporosis Drug Prolia Is Hit With FDA’s Strictest Warning

Study finds no link between Novo Nordisk’s GLP-1 drugs and suicidal ideation

Drug companies know how to play the FDA drug approval process

KRAS crisis? FDA will gather advisers to weigh full approval for Amgen's Lumakras

Base-Editing Biotech Beam Restructures, Narrowing Pipeline & Cutting 20% of Staff

Ionis Posts Trial Data in Rare Disease That Position It to Finally Set Out on Its Own

Otsuka Commits $800M in M&A Deal Bringing a Phase 3-Ready Metabolic Disorder Drug

J&J, Legend's Carvykti bid for earlier multiple myeloma use will face FDA adcomm

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