Fierce Pharma

APRIL 19, 2024

The Swiss pharma has now secured an FDA approval in the post-surgical setting as it continues to test the drug in additional patient populations. Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer.

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Fierce Pharma

NOVEMBER 5, 2024

With its first FDA approval coming in August and a sec | With its first FDA approval coming in August and a second expected next month, these are exhilarating days for 19-year-old Syndax Pharmaceuticals as it transforms into a commercial enterprise.

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Fierce Pharma

APRIL 17, 2024

One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said. |

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Fierce Pharma

OCTOBER 23, 2024

The war is on between compounding pharmacies making knockoff versions of popular weight loss drugs and pharma giants Novo Nordisk and Eli Lilly, who want to protect their right to sell their patent | Novo Nordisk has asked the FDA to prevent compounders from manufacturing copycat versions of its juggernaut diabetes and obesity treatments Ozempic and (..)

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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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Fierce Pharma

FEBRUARY 16, 2024

The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunothera | The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA (..)

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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. | 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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Fierce Pharma

OCTOBER 18, 2024

After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. Astellas' Vyloy won an FDA approval to treat gastric or gastroesophageal junction adenocarcinoma patients whose tumors are CLDN18.2

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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

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Fierce Pharma

OCTOBER 8, 2024

With an estimated 2 million people in the United States taking copycat vers | A compounding industry group has sued the FDA, claiming its action to remove Eli Lilly’s Mounjaro and Zepbound from its drug shortage list is a “reckless and arbitrary decision—lacking any semblance of lawful process.”

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Fierce Pharma

JUNE 9, 2023

After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing.

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Fierce Pharma

APRIL 26, 2024

Ten years after dipping its toes into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained FDA approval for the acquired treatment. | Ten years after dipping its toe into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained an FDA approval for the acquired treatment.

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Fierce Pharma

APRIL 9, 2024

At an FDA advisory committee meeting this Friday, two teams will present their studies examining the utility of minimal residue disease (MRD) as a potentially approvable endpoint in multiple myeloma. noticed an encouraging yet potentially concerning trend in the treatment of multiple myeloma. |

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Fierce Pharma

NOVEMBER 14, 2024

The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy has already been approved to treat AADC deficiency in Europe and the U.K., among other countries, where it's branded as Upstaza.

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Fierce Pharma

DECEMBER 19, 2024

Following in the footsteps of several Big Pharma companies, another ALK inhibitor has made its entry into the U.S. The FDA nod comes four years after its initial approval in China. Following in the footsteps of Pfizer, Roche and Takeda, another ALK inhibitor has made its belated entry into the U.S.

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Fierce Pharma

JUNE 26, 2024

In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered partnered antibody drug conjugate (ADC) patritumab deruxtecan. |

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Fierce Pharma

AUGUST 2, 2024

Adaptimmune has won accelerated FDA approval | Adaptimmune has won accelerated FDA approval for Tecelra (afami-cel), a treatment for metastatic or unresectable synovial sarcoma which becomes the first engineered cell therapy for a solid tumor and the first new treatment in the indication in more than a decade.

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Fierce Pharma

MARCH 8, 2024

Novo Nordisk’s fast-growing weight loss med Wegovy just added a new cardiovascular FDA approval to its label, likely enabling the med's superstar status to reach new levels. |

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Fierce Pharma

APRIL 19, 2023

Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations zbecker Wed, 04/19/2023 - 11:04

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Fierce Pharma

JULY 26, 2024

After Eli Lilly’s Olumiant won the distinction of becoming the first med approved by the FDA to treat the follicle-attacking autoimmune disease alopecia areata, Pfizer followed up with a green ligh | The FDA signed off on Sun’s oral JAK inhibitor deuruxolitinib to treat adults with severe alopecia areata.

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Fierce Pharma

MAY 31, 2024

With the FDA nod, Moderna's RSV vaccine becomes the company's second product to secure the FDA's backing.

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Fierce Pharma

AUGUST 14, 2024

With an FDA appro | The FDA has approved Gilead's primary biliary cholangitis treatment Livdelzi. The drug, which was acquired in a $4.3 billion buyout of CymaBay Therapeutics six months ago, is the first inflammatory treatment launched by Gilead.

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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.

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Fierce Pharma

JUNE 26, 2024

The FDA in March converted Johnson & Johnson’s Rybrevant use in previously treated EGFR exon20 insertion-mutated non-small cell lung cancer into a full nod.

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Fierce Pharma

MAY 19, 2023

Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease zbecker Fri, 05/19/2023 - 16:25

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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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Fierce Pharma

JUNE 7, 2024

Once hailed as an anti-aging magic bullet, telomerase has failed to live up to the hype as it was profiled in a | The FDA has approved Geron Corporation's Rytelo (imetelstat) to treat a group of bone marrow disorders called myelodysplastic syndrome (MDS). The approval is the first for the 33-year-old California biotech.

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Fierce Pharma

AUGUST 7, 2024

The first horse carrying Novartis’ immunoglobulin A nephropathy (IgAN) troika has crossed the FDA finish line. | The first horse carrying Novartis’ immunoglobulin A nephropathy (IgAN) troika has crossed the FDA finish line.

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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

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Fierce Pharma

DECEMBER 8, 2023

Alongside a historic approval for the first therapy utilizing the Nobel Prize-winning CRISPR/Cas9 gene-editing technology, the FDA has cleared a rival gene replacement therapy, also for sickle cell | Alongside a historic approval for the first therapy utilizing the Nobel Prize-winning CRISPR/Cas9 gene-editing technology, the FDA has cleared a rival (..)

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Fierce Pharma

JUNE 29, 2023

After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder.

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Fierce Pharma

MAY 8, 2024

In a letter to FDA Commissioner Robert Califf, M.D., Amid a U.S. | the House Committee on Oversight and Accountability chairman argued that China’s influence over global pharmaceutical supply chains constitutes an act of economic warfare against the United States.

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Fierce Pharma

AUGUST 13, 2024

When the FDA approved Amgen’s Imdelltra in May, the T-cell engager was hailed as a breakthrough for the treatment of small cell lung cancer (SCLC) and as the first DLL3-targeting therapy of potenti | In granting an accelerated approval to Amgen's first-in-class DLL3 bispecific Imdelltra, the FDA had to work through a “large number” of missing (..)

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Fierce Pharma

JUNE 17, 2024

The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by senio | The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning (..)

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Fierce Pharma

DECEMBER 16, 2024

The FDA has blessed two previously approved medicinesone a cream and the other an injectionto treat atopic dermatitis (AD). | The FDA has blessed two previously approved medicinesone a cream and the other an injectionto treat atopic dermatitis (AD).

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Fierce Pharma

DECEMBER 19, 2024

The FDA has doubled down on its decision to remove Eli Lillys tirzepatide from its list of products that are in shortage. | The FDA has doubled down on its decision to remove Eli Lillys tirzepatide from its list of products that are in shortage.

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Fierce Pharma

JANUARY 16, 2024

Vertex Pharmaceuticals and CRISPR Therapeutics have scored an FD | Vertex Pharmaceuticals and CRISPR Therapeutics have scored an FDA approval for their gene-editing therapy Casgevy (exa-cel) to treat transfusion-dependent beta thalassemia (TDT). The approval came more than two months ahead of the FDA's March 30 decision date.

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