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. Many cancer meds approved under the FDA's accelerated approval pathway from 2013 to 2017 didn't improve overall survival after more than five years of follow-up research, the study found.

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Fierce Pharma

APRIL 8, 2024

The FDA refused to accept Supernus' first approval bid after the company acquired the med in 2020. The third time is decidedly not the charm for Supernus and its Parkinson’s disease infusion pump. | The following year, the agency doled out a complete response letter, dashing Supernus' second try.

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FDA 295

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. Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer.

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Fierce Pharma

MARCH 5, 2024

Vanda has been waiting years for an FDA hearing to contest the agency’s 2019 rejection of its sleep drug Hetlioz in jet lag disorder. Vanda has been waiting years for an FDA hearing to contest the agency’s 2019 rejection of its sleep drug Hetlioz in jet lag disorder. regulator, the FDA has crushed Vanda’s bid.

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FDA 287

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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FDA 340

Fierce Pharma

APRIL 3, 2024

Fifteen years after gaining its first FDA approval for Fanapt (iloperidone) to treat schizophrenia, Vanda Pharmaceuticals has scored again with the same antipsychotic drug. The FDA has signed off on Fanapt tablets to treat adults with manic or mixed episodes associated with bipolar I disorder.

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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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FDA 348

Fierce Pharma

APRIL 11, 2024

After investigations into the FDA’s response to severe drug shortages and other issues, the House Committee on Oversight and Accountability finally had its long-awaited chance to grill the agency’s | FDA Commissioner Robert Califf, M.D., The Oversight Committee hearing touched on a range of other issues, too.

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FDA 303

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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FDA 306

Fierce Pharma

APRIL 10, 2024

The FDA appears receptive to the idea of using the measurement to support accelerated approvals of new drugs, even though the agency has a few questions. New data have come forward pointing to a link between achieving undetectable minimal residual disease (MRD) and improved treatment outcomes in multiple myeloma. |

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FDA 289

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

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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FDA 296

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

MARCH 6, 2024

Two biosimilars to Amgen’s lucrative bone drugs Prolia and Xgeva have clinched approvals at the FDA, though ongoing patent litigation makes launch timing uncertain. Sandoz has clinched FDA approvals for biosimilars to Amgen’s denosumab.

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FDA 264

Fierce Pharma

FEBRUARY 23, 2024

Following a contentious advisory committee meeting and an FDA request for the withdrawal of Oncopeptides’ multiple myeloma drug Pepaxto from the U.S. Following a contentious advisory committee meeting and an FDA request for withdrawal of Oncopeptides’ multiple myeloma drug Pepaxto from the U.S.

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Fierce Pharma

FEBRUARY 16, 2024

Four months after the FDA rejected Sanofi and Regeneron’s Dupixent to treat chr | Four months after the FDA rejected Sanofi and Regeneron’s Dupixent to treat chronic spontaneous urticaria, Japan’s health regulators have signed off on the drug in the indication.

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FDA 256

Fierce Pharma

JANUARY 30, 2024

A nasal gel version of the motion sickness drug scopolamine has failed to make the grade with the FDA. A nasal gel version of the motion sickness drug scopolamine has failed to make the grade with the FDA. The U.S. |

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Fierce Pharma

MARCH 19, 2024

Despite Translarna's troubled history at the FDA—and a recent regulatory stumble in Europe—PTC Therapeutics once again hopes to convince U.S. Despite Translarna's troubled history at the FDA—and a recent regulatory stumble in Europe—PTC Therapeutics once again hopes to convince U.S.

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FDA 226

Fierce Pharma

APRIL 2, 2024

Four dose strengths are now expected to be in short supply through April, according to the FDA. 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.

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FDA Patients 316

Fierce Pharma

APRIL 5, 2024

Amid ongoing drug shortages and other headline-grabbing issues that fall under the FDA’s purview, the House Committee on Oversight and Accountability is putting the agency’s commissioner Robert Cal | The April 11 hearing could be contentious, as the committee wants to “hold the commissioner accountable" for the FDA's action on drug shortages, (..)

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FDA 283

Fierce Pharma

APRIL 10, 2024

FDA chided Kilitch Healthcare India for “poor practices” tied to written procedures around microbial contamination, shoddy lab records, behaviors that could have caused contamination and quality control lapses. In a four-observation warning letter issued this week, the U.S.

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Fierce Pharma

FEBRUARY 27, 2024

More than two years after a high-profile FDA rejection, AstraZeneca has backed out of a collaboration with FibroGen for the latter’s oral anemia drug roxadustat in the U.S. AstraZeneca and FibroGen have finally reached the end of the road for their U.S. collaboration on the oral anemia drug roxadustat.

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FDA 312

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

MARCH 27, 2024

Akebia never lost confidence in its oral chronic kidney disease (CKD) anemia drug Vafseo, even after the FDA nixed its first approval bid two years ago with a complete response letter.

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FDA Marketing 289

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. About 15 years ago, Carl Ola Landgren, M.D. noticed an encouraging yet potentially concerning trend in the treatment of multiple myeloma. |

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Fierce Pharma

MARCH 13, 2024

The FDA has raised concerns about early clinical trial deaths as part of two applications that aim to move the CAR-T therapies Carvykti and Abecma into earlier lines of treatment for multiple myelo | Ahead of an important advisory committee meeting, the FDA has raised concerns about early trial deaths for multiple myeloma cell therapies.

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FDA 296

Fierce Pharma

APRIL 23, 2024

Dating to a 2019 clinical hold of a phase 3 trial, getting its gene therapy ra | Dating to a 2019 clinical hold, getting its gene therapy pz-cel across the FDA finish line has been a challenge for troubled Abeona Therapeutics. Now the wait continues as the FDA has rejected the treatment due to CMC issues.

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FDA 191

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

MARCH 11, 2024

Viatris likely just lost one of its top product debuts for 2024, thanks to an FDA rejection of its partner Mapi Pharma’s application for a new version of Teva’s multiple sclerosis (MS) drug Co | Viatris likely just lost one of its top product debuts for 2024, thanks to an FDA rejection of its partner Mapi Pharma’s application for a new version of Teva’s (..)

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FDA 268

Fierce Pharma

FEBRUARY 12, 2024

With a patent feud settled and its approval application back at the FDA’s desk, Sweden’s Xspray Pharma believes it's on track to launch its first commercial product late this summer. The FDA is now expected to decide on Dasynoc by July 31.

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Fierce Pharma

MARCH 11, 2024

Ever since its first FDA rejection five years ago, Lexicon Pharmaceuticals hasn’t given up hope on its Type 1 diabetes prospect sotagliflozin. | The company hopes its long and bumpy five-year journey will soon see an end with an FDA approval. Lexicon looks to resubmit the drug by the middle of the year.

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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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FDA Pharmaceutical 306

Fierce Pharma

FEBRUARY 27, 2024

Over the last few days, as the FDA rejected one antibiotic combination treatment for complicated urinary tract infections (cUTIs), it has approved another. Over the last few days, as the FDA rejected one antibiotic combination treatment for complicated urinary tract infections (cUTIs), it has approved another.

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FDA 258

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

NOVEMBER 10, 2023

The FDA has approved the world’s first chikungunya vaccine, giving a thumbs-up to Valneva’s Ixchiq. The French company receives a priority review voucher from the FDA, which it said it will sell. Valneva has won the race in the U.S. | It is an accelerated approval and subject to a confirmatory, real-world study.

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FDA 271

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. |

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FDA Medicine 303

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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