Fierce Pharma

NOVEMBER 28, 2023

In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. |

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pharmaphorum

APRIL 29, 2024

Patients in the US with the ultra-rare disease WHIM syndrome now have their first approved treatment, after X4 Pharma’s Xolremdi was given a green light by the FDA.

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Fierce Pharma

APRIL 2, 2024

Amid steadily increasing demand for Eli Lilly’s popular diabetes med Mounjaro, it appears patients on multiple dose strengths may have to wait even longer than anticipated to re-up on supply. Four dose strengths are now expected to be in short supply through April, according to the FDA.

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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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Fierce Pharma

MARCH 19, 2024

Twelve years after Takeda's Iclusig (ponatinib) earned a restricted FDA approval to treat certain patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL), the U.S. regulator has signed off on a wider use.

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Fierce Pharma

APRIL 29, 2024

Following a 10-year development journey, the FDA on Monday approved X4 Pharmaceuticals’ Xolremdi. The nod marks X4’s commercial debut and provides WHIM patients with the first therapy to tackle the underlying cause of their disease.

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Fierce Pharma

JANUARY 22, 2024

When the FDA converts an accelerated approval into a full nod, it’s typically associated with a wider label for the drug at hand. When the FDA converts an accelerated approval into a full nod, it's typically associated with a wider label for the drug at hand.

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MedCity News

FEBRUARY 20, 2024

The FDA clinical hold follows a patient death from liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule.

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Fierce Pharma

DECEMBER 20, 2023

Seven months after Krystal Biotech became the first company to gain FDA approval to treat the rare, devastating skin disease epidermolysis bullosa (EB), Chiesi Farmaceutici has followed suit. On Tuesday, the U.S.

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Fierce Pharma

SEPTEMBER 11, 2023

The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old. Out with the old and in with the new: Monday, the U.S. |

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World of DTC Marketing

MARCH 18, 2021

SUMMARY: The FDA wants to look at how certain brand names affect consumer and health care providers’ perceptions about the efficacy and the medical conditions for which they’re indicated. This is just another example of how clueless the FDA is regarding patient behavior and prescription drugs. The post Dear FDA: WTF?

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Fierce Pharma

JANUARY 4, 2024

On Tuesday, the FDA revealed that it is investigating patient reports of suicidal thoughts and hair loss from the use of the blood sugar-modulating products. Could cautions about more common side effects soon be added to the labels of popular treatments such as Novo’s Ozempic and Lilly’s Mounjaro?

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Side effects FDA Patients 335

Fierce Pharma

FEBRUARY 13, 2024

The FDA has approved Onivyde as part of a combination dubbed Nalirifox to treat patients with newly diagnosed metastatic pancreatic cancer. It’s the approval Ipsen has been waiting for since buying up Onivyde in 2017. It’s the approval Ipsen has been waiting for since buying up Onivyde in 2017.

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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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Competition FDA Patients Pharma 107

Fierce Pharma

DECEMBER 15, 2023

With a second FDA nod for a much larger patient population, the company can anticipate a more pronounced upswing in revenue from the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor.

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Fierce Pharma

OCTOBER 16, 2023

Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer. Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery.

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Fierce Pharma

NOVEMBER 9, 2022

FDA signs off on Sobi's Kineret for COVID patients with pneumonia who are on oxygen. Wed, 11/09/2022 - 16:21.

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Fierce Pharma

SEPTEMBER 11, 2023

Ahead of an important advisory committee meeting, the FDA has raised serious questions about Alnylam’s bid to expand Onpattro into a much larger group of patients with transthyretin amyloidosis (AT | The FDA has raised questions about Alnylam's Onpattro as the company seeks to expand the drug into a much larger group of patients with transthyretin (..)

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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 (..)

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Fierce Pharma

FEBRUARY 29, 2024

Despite a restricted FDA label, Sarepta Therapeutics has seen early commercial success with its Duchenne muscular dystrophy (DMD) gene therapy Elevidys. | The company is quickly moving through Elevidys' eligible patient population while awaiting the FDA's decision on a broader label.

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World of DTC Marketing

JULY 9, 2021

SUMMARY: Pfizer asks for accelerated approval for a COVID booster shot even though the FDA says it’s unnecessary. The drug industry is driven by profits, not by patient’s needs. We are reminded that big pharma is a business whose only purpose is to make money. Big pharma is big business. billion. .”

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Fierce Pharma

SEPTEMBER 26, 2023

It’s been an uphill battle for Intercept Pharmaceuticals in the three years since the FDA first nixed its attempt to bring Ocaliva to patients with nonalcoholic steatohepatitis (NASH)-related liver | The company inked the buyout at $19 per share after two FDA rejections for Ocaliva in nonalcoholic steatohepatitis-related liver fibrosis and a recent (..)

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Fierce Pharma

DECEMBER 9, 2023

BCMA-targeted therapies are transforming care for multiple myeloma patients. A new study examined side effect reports of BMCA immunotherapies from the FDA Adverse Event Reporting System, hoping to help inform doctors in their treatment decisions. But these immunotherapies also come with various potentially dangerous side effects. |

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Fierce Pharma

DECEMBER 14, 2023

While existing neuroblastoma treatments can help patients achieve remission, sustaining that remission has proven tricky. But now, patients and doctors have a new oral option. | FDA has approved US WorldMeds’ Iwilfin—also known as eflornithine—as a new oral maintenance therapy for high-risk neuroblastoma.

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Fierce Pharma

APRIL 26, 2023

FDA argues AstraZeneca, Merck's Lynparza only works in subset of prostate cancer patients aliu Wed, 04/26/2023 - 14:19

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Fierce Pharma

APRIL 4, 2024

After two delays spanning more than a year, Novartis is finally gearing up for a high-stakes FDA application to expand the radiotherapy Pluvicto into earlier treatment of prostate cancer. But will the FDA bite?

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FDA Patients 209

Pharmaceutical Technology

JUNE 21, 2023

The US Food and Drug Administration (FDA) has granted Teikoku Pharma’s dexmedetomidine transdermal system a fast track designation. With an estimated enrollment of 182 patients undergoing abdominoplasty, the company will present data comparing its transdermal system with a placebo in Q3 of 2023.

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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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Fierce Pharma

NOVEMBER 20, 2023

Thanks to a new FDA approval, patients with ultra-rare desmoid tumors now have an FDA-approved treatment. Patients with ultra-rare desmoid tumors now have an FDA-approved treatment, thanks to a drug made by SpringWorks Therapeutics, which spun out of Pfizer in 2017 with a portfolio of rare disease candidates.

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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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Fierce Pharma

DECEMBER 21, 2023

Ionis Pharmaceuticals and AstraZeneca are wrapping up the year with a much-anticipated present from the FDA: an approval for the companies’ transthyretin amyloidosis (ATTR) drug Wainua. |

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Fierce Pharma

OCTOBER 12, 2023

After the FDA passed on an approval for mirikizumab in ulcerative colitis earlier this year because of manufacturing shortfalls, the Eli Lilly drug is gaining new momentum with a win in a phase 3 C | A majority of Crohn's disease patients experienced a clinical response and clinical remission after treatment with mirikizumab, the company said.

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World of DTC Marketing

DECEMBER 1, 2020

Walk into any corporate pharma HQ, and you’re likely to see a mission statement that’s pure b t about how patients come first. We all know that Wall Street and sales come well before patients. Just look at any pharma product website that is nothing but a sales brochure in a majority of cases. Want proof?

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Fierce Pharma

OCTOBER 27, 2023

After a quick FDA approval in a subgroup of endometrial cancer patients, GSK is trumpeting a win for its Jemperli that might help the PD-1 inhibitor expand to a broader population.

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FDA Patients 184

World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. Biogen’s failure should be a warning to other pharma companies. It should be a warning to other pharma companies. ” Pharma CEOs are compensated on how their products earn money. .”

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Fierce Pharma

JULY 25, 2023

Patients with the eyelid disease Demodex blepharitis can now see a cure in Tarsus Pharmaceuticals’ Xdemvy, the first FDA-approved treatment for an ailment that affects some 25 million Americans.

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FDA Pharmaceutical Patients 224

Fierce Pharma

DECEMBER 1, 2023

After a hard-fought battle for FDA approval, AstraZeneca has hit another setback on its quest to turn its potassium-reduction drug Lokelma into a blockbuster. AstraZeneca has put the kibosh on two late-stage Lokelma trials testing the hyperkalemia drug in patients with heart and kidney diseases.

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Pharma FDA Patients 223