FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy
Fierce Pharma
MAY 31, 2023
FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy kdunleavy Wed, 05/31/2023 - 13:02
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Fierce Pharma
MAY 31, 2023
FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy kdunleavy Wed, 05/31/2023 - 13:02
Fierce Pharma
SEPTEMBER 11, 2023
After 10 years of stagnation, a new FDA approval could help more cancer patients become eligible for stem cell transplants. |
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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. |
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.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
A recent draft from the FDA provides valuable insight. Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinical development? What will the future hold for clinical research?
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.
Fierce Pharma
MARCH 15, 2024
The FDA questioned whether Carvykti should be approved in an earlier line of multiple myeloma after noticing an early detriment to patient survival in a clinical trial. . | WuXi AppTec left BIO amid alleged biosecurity concerns and as U.S. lawmakers target certain Chinese biotechs. And more.
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.
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.
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.
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. |
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?
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.
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.
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.
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 (..)
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 (..)
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.
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 (..)
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.
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.
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.
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.
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.
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.
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. |
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. |
Fierce Pharma
FEBRUARY 16, 2024
After Elevidys scored an FDA approval in a restricted group of patients, Sarepta's attempt for a larger indication has snared a priority review.
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
Fierce Pharma
SEPTEMBER 28, 2023
The FDA has signed off on Takeda’s subcutaneous version of Entyvio to be used as a maintenance therapy for patients with ulcerative colitis.
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.
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.
Pharmaceutical Technology
MARCH 25, 2024
The US FDA approved Johnson & Johnson's (J&J) OPSYNVI for chronic treatment in adult patients with pulmonary arterial hypertension.
Fierce Pharma
NOVEMBER 7, 2023
But the companies’ failure to win over regulators for Zurzuvae to treat a significantly larger patient population threw their pricing strategy out the window.
Fierce Pharma
NOVEMBER 9, 2023
Thanks to a Takeda approval Thursday, patients now have a drug to tackle a rare inherited blood clotting disorder. | The FDA has given a green light to Takeda’s Adzynma, the first recombinant protein product as a preventative or on demand enzyme replacement therapy in adults and kids with congenital thrombotic thrombocytopenic purpura.
pharmaphorum
DECEMBER 20, 2023
FDA OKs test to spot patients at risk of opioid use disorder Phil.Taylor Wed, 20/12/2023 - 10:14 Bookmark this
World of DTC Marketing
MARCH 23, 2022
Do patients care? Accelerated Approval was developed in 1992 in response to the HIV/AIDS crisis and has led to expedited drug and biologic approvals in several disease areas across the FDA. Do patients care? Should patients be made aware that the drug they are being prescribed is an “accelerated approval drug”?
Fierce Pharma
MARCH 18, 2024
After a quick FDA approval in a subset of endometrial cancer, GSK is back with more data for two Jemperli regimens in hopes of reaching a broader patient population. And AstraZeneca, utilizing a similar immunotherapy strategy, has also come up with a rivaling update as it awaits an FDA decision.
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?
Pharmaceutical Technology
MARCH 4, 2024
For Rare Disease Day, several panels organised by the FDA discussed the importance overcoming accessibility barriers during drug development.
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.
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.
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.
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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