Fierce Pharma

JULY 11, 2024

The FDA has slowed the roll for Novo Nordisk, rejecting its once-a-week insulin icodec for patients with Type 1 and Type 2 diabetes. In surging to the top spot in the market cap rankings in Europe, Novo Nordisk has been on an extended winning streak. | In a complete response letter, the U.S.

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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

JUNE 25, 2024

A little over a year after being slapped with an FDA rejection, AbbVie has hit another regulatory wall in its bid to debut a more convenient Parkinson’s disease successor to its established fo | A little over a year after being slapped with an FDA rejection, AbbVie has hit another regulatory wall in its bid to debut a more convenient Parkinson’s disease (..)

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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

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

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

JUNE 10, 2024

About a month after Eisai initiated a rolling FDA application for its subcutaneous form of Leqembi, the U.S. The FDA assigned the subcutaneous Leqembi application a Prescription Drug User Fee Act decision date of January 25, 2025. agency has accepted the filing. |

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Fierce Pharma

JUNE 20, 2024

The FDA has expanded the label for Sarepta's Elevidys to all Duchenne muscular dystrophy patients ages 4 and older. There’s no slowing the momentum of Sarepta’s groundbreaking Duchenne muscular dystrophy (DMD) gene therapy Elevidys—not even the failure of a confirmatory trial. |

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Fierce Pharma

MAY 14, 2024

It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide). It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide).

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Fierce Pharma

APRIL 1, 2024

What analysts viewed as a potential “inflection point” for Eisai and Biogen’s slow-footed Leqembi is facing a delay with the FDA. What analysts viewed as a potential “inflection point” for Eisai and Biogen’s slow-footed Leqembi is facing a delay with the FDA.

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Fierce Pharma

MAY 16, 2024

China-made PD-1 inhibitors just can’t get a clean pass through the FDA. | China-made PD-1 inhibitors continue to struggle at the FDA. This week, the U.S. agency rejected Elevar Therapeutics and Jiangsu Hengrui Pharma's PD-1 combination in liver cancer.

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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

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

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

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 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

APRIL 30, 2024

Federal Trade Commission (FTC) is not done with its crackdown on what it views as improper listing of patents with the FDA. | FTC is not done with its crackdown on what it views as improper listing of patents in the FDA Orange Book.

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Fierce Pharma

JULY 11, 2024

Following this month's FDA approval of Eli Lilly’s amyloid-busting antibody Kisunla (donanemab), the Alzheimer’s disease market is set to grow in earnest—and Lilly is already eyeing a spot at the t | On top of Eisai and Biogen's Leqembi, Kisunla’s approval likely marks the “end of the beginning in treating this disease,” Andrew Lechleiter, (..)

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Fierce Pharma

JUNE 27, 2024

The FDA rejected Daiichi Sankyo and Merck's HER3 antibody-drug conjugate. The FDA rejected Daiichi Sankyo and Merck's HER3 antibody-drug conjugate. Novo Nordisk's weight loss star Wegovy secured approval in China. | Novo Nordisk's weight-loss star Wegovy secured approval in China.

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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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Fierce Pharma

MARCH 25, 2024

Nearly five years after an FDA approval for Soliris in neuromyelitis optica spectrum disorder (NMOSD), AstraZeneca’s follow-on C5 drug Ultomiris has entered the rare neurological disease, as well.<

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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 6, 2024

When the FDA comes knocking at your drug manufacturing facility, it’s best to play along. |

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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 4, 2024

Fifteen years after Basilea's antibiotic ceftobiprole sustained a rejection from the FDA, the company has finally won over the U.S. regulator and done so in triplicate. | Fifteen years after Basilea's antibiotic ceftobiprole sustained a rejection from the FDA, the company has finally won over the U.S.

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Fierce Pharma

JUNE 20, 2024

The med is the first new chemical entity to win FDA approval specifically to treat primary axillary hyperhidrosis, or excessive underarm sweating. Everybody sweats, but for the 10 million people in the U.S. living with primary axillary hyperhidrosis, sweating can take on a whole new meaning. |

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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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Fierce Pharma

APRIL 23, 2024

Compared with an incumbent offering from Novartis, the newcomer boasts an FDA approval covering a broader patient population. Compared with an incumbent offering from Novartis, Day One's newcomer boasts an FDA approval covering a broader patient population. Another drug is in town for common pediatric brain tumors.

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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

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

MAY 14, 2024

Late Tuesday, Biogen and Eisai said they kicked off a rolling FDA submission for the subcutaneous version of Leqembi—which is currently infused—after winning a fast track tag from the agency. After suffering a setback with U.S.

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Fierce Pharma

APRIL 22, 2024

After a merger and an FDA rejection, celebrity businessman and biotech entrepreneur Patrick Soon-Shiong’s ImmunityBio has landed the company’s first U.S. After a merger and an FDA rejection, celebrity businessman and biotech entrepreneur Patrick Soon-Shiong’s ImmunityBio has landed the company’s first U.S.

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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

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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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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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 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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