Fierce Pharma

NOVEMBER 1, 2024

An FDA announcement last year of an investigation into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry. | said in an interview with Fierce Pharma.

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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

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

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

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

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

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

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

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

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

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

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

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

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

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

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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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

SEPTEMBER 11, 2023

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

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Fierce Pharma

SEPTEMBER 28, 2023

Fabre-Kramer Pharmaceuticals' major depressive disorder (MDD) drug gepirone has been rejected by the FDA not once, not twice, but three times since the turn of the millennium. Fabre-Kramer's Exxua suffered three prior FDA rejections before scoring an FDA approval for major depressive disorder last week.

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Fierce Pharma

OCTOBER 14, 2024

Four days after a compounding industry group filed a lawsuit against the FDA | Four days after a compounding industry group filed a lawsuit against the FDA for removing Eli Lilly’s tirzepatide products from its shortage list, the U.S. regulator is taking a second look at its decision.

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Fierce Pharma

OCTOBER 11, 2024

Six months after scoring FDA approval for hemophilia B gene therapy Beqvez, Pf | For the second time in six months, the FDA approved a Pfizer treatment for hemophilia. On Friday the U.S. regulator signed off on Hympavzi, an anti-tissue factor pathway inhibitor for patients age 12 and older with hemophilia A or B.

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Fierce Pharma

APRIL 5, 2024

After a short period of doubt, the FDA has followed the opinion of its advisers and moved Bristol Myers Squibb’s CAR-T therapy Abecma into the earlier treatment of multiple myeloma.

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Fierce Pharma

DECEMBER 4, 2024

The FDA had originally pushed its decision back by three months after a November manufacturing-related delay. Merus’ week keeps getting better. |

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Fierce Pharma

AUGUST 30, 2023

And the FDA's approval of several generics comes amid a U.S. After 16 years on the market, Takeda's blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff. | After 16 years on the market, Takeda's blockbuster ADHD med Vyvanse has finally reached its patent cliff.

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Fierce Pharma

OCTOBER 17, 2024

AbbVie made history in 2015 with its Parkinson’s disease infusion pump therapy Duopa, kicking off a trend of delivery system innovation in the space as drugmakers sought to avoid the common pitfall | The 24-hour Parkinson's disease therapy crossed the FDA finish line after an initial manufacturing-related rejection last year and another snub in (..)

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Fierce Pharma

JUNE 26, 2024

Verona Pharma has earned an FDA approval for Ohtuvayre, a potential blockbuster with a novel mechanism of action, to treat patients with chronic obstructive pulmonary disorder (COPD). Thirteen years after his passing, Sir David Jack still looms as an innovative force in healthcare.

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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.

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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. . | Use of Novo Nordisk and Eli Lilly’s popular diabetes and weight loss drugs come with warnings about a rare intestinal blockage condition called ileus.

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Fierce Pharma

DECEMBER 6, 2023

With an FDA approval in PNH, Novartis has gained its first nod for iptacopan, dubbed two months ago “a pipeline in pill," by analysts at ODDO BHF.

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Fierce Pharma

FEBRUARY 12, 2024

Eohilia, an oral suspension formulation of the corticosteroid budesonide, has surprisingly won over the FDA even after the drug’s developer, Takeda, had at one point abandoned the program following | Takeda's Eohilia has surprisingly won over the FDA even after the company had at one point abandoned the program following an FDA rejection.

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