Pharmaceutical Technology

AUGUST 13, 2024

Ascendis Pharma has obtained US Food and Drug Administration (FDA) approval for its YORVIPATH to treat hypoparathyroidism in adults.

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Pharmaceutical Technology

AUGUST 8, 2024

Novartis has secured US Food and Drug Administration (FDA) accelerated approval for Fabhalta (iptacopan) to treat igAN.

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Pharmaceutical Technology

NOVEMBER 15, 2024

The US Food and Drug Administration (FDA) has approved Azurity Pharmaceuticals’ Danziten (nilotinib), the first and only nilotinib formulation that does not require mealtime restrictions, to treat chronic myeloid leukaemia (CML).

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Pharmaceutical Technology

NOVEMBER 14, 2024

The US Food and Drug Administration (FDA) has granted accelerated approval for PTC Therapeutics’ KEBILIDI, the first gene therapy in the US that is directly delivered to the brain.

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Fierce Pharma

JULY 26, 2023

Food and Drug Administration has added a fourth dose of Lilly’s popular new diabetes med to its drug shortage database. As with Novo Nordisk’s popular offering for obesity, Wegovy, demand for Eli Lilly’s dual GIP/GLP-1 agonist Mounjaro appears to be outpacing supply once again. |

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Pharmaceutical Technology

NOVEMBER 11, 2024

Dizal has submitted sunvozertinib’s new drug application (NDA) to the US Food and Drug Administration (FDA) aiming to secure approval for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutations.

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Pharmaceutical Technology

NOVEMBER 1, 2024

Verastem Oncology has concluded the rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for a combination of avutometinib and defactinib for low-grade serous ovarian cancer (LGSOC).

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Pharmaceutical Technology

JUNE 3, 2024

Moderna has secured approval from the US Food and Drug Administration (FDA) for mRESVIA (respiratory syncytial virus vaccine).

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Legacy MEDSearch

OCTOBER 18, 2023

Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform. Food and Drug Administration (FDA) 510(k) Clearance for its FreedomFlow® Orbital Atherectomy Peripheral Platform Press Release by: Cardio Flow, Inc. Cardio Flow, Inc. ,

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Legacy MEDSearch

NOVEMBER 3, 2023

Food and Drug Administration (FDA). FOOD AND DRUG ADMINISTRATION FOR STELLAR KNEE Press Release by: POLARISAR Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. See Full Press Release at the Source: POLARIS AR RECEIVES CLEARANCE FROM THE U.S.

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Pharmaceutical Technology

NOVEMBER 12, 2024

The US Food and Drug Administration (FDA) has awarded the second breakthrough therapy designation (BTD) to Johnson & Johnson's (J&J) nipocalimab for treating individuals with moderate-to-severe Sjögren’s disease (SjD).

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Pharmaceutical Technology

APRIL 29, 2024

Pfizer has received approval from the US Food and Drug Administration (FDA) for its one-time gene therapy BEQVEZ for haemophilia B.

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Pharmaceutical Technology

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has accepted to review Orexo’s new drug application (NDA) for opioid overdose medication, OX124.

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Pharmaceutical Technology

APRIL 19, 2024

The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy AB-1002, aimed at treating congestive heart failure (CHF).

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Pharmaceutical Technology

SEPTEMBER 27, 2024

The US Food and Drug Administration (FDA) has announced the approval of Sanofi and Regeneron’s interleukin (IL)-4 and IL-13 monoclonal antibody, Dupixent, for the US market.

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Pharmaceutical Technology

JUNE 7, 2024

Agomab Therapeutics has now secured a US Food and Drug Administration (FDA) orphan drug designation for IPF treatment AGMB-447.

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Pharmaceutical Technology

DECEMBER 19, 2023

Pharmaceutical Technology outlines some of the biggest US Food and Drug Administration (FDA) drug approvals announced in 2023 that are set to make an impact in the coming years.

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Pharmaceutical Technology

OCTOBER 14, 2024

Pfizer has announced the approval of HYMPAVZI by the US Food and Drug Administration (FDA) for patients with haemophilia A and B.

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Pharmaceutical Technology

SEPTEMBER 16, 2024

Roche has secured approval from the US Food and Drug Administration for Ocrevus Zunovo with Halozyme's Enhanze drug delivery technology.

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Pharmaceutical Technology

OCTOBER 1, 2024

BPGbio has received a Rare Pediatric Disease Designation from the US Food and Drug Administration (FDA) for BPM31510IV to treat primary coenzyme Q10 deficiency, an ultra-rare mitochondrial disorder.

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Pharmaceutical Technology

DECEMBER 4, 2023

The US Food and Drug Administration (FDA) has granted approval for Ambio’s generic version of Forteo for the treatment of osteoporosis.

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Pharmaceutical Technology

OCTOBER 4, 2024

Bristol Myers Squibb (BMS) has received approval from the US Food and Drug Administration (FDA) for Opdivo to treat adults with resectable non-small cell lung cancer (NSCLC).

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Pharmaceutical Technology

SEPTEMBER 4, 2024

The US Food and Drug Administration (FDA) has granted fast track designation to Innovent Biologics' IBI363 for treating melanoma.

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MedCity News

MARCH 16, 2023

Physicians face a lot of barriers from insurers in completing studies on drugs in the accelerated approval pathway, declared Dr. Robert Califf, commissioner of food and drugs at the Food and Drug Administration.

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Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The drug is not currently approved in any markets globally.

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Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has granted rare paediatric drug designations for IPS HEART’s stem cell therapeutics, GIVI-MPC and ISX9-CPC, to treat Duchenne muscular dystrophy (DMD) patients. The drug candidate received an orphan drug designation (ODD) from the FDA in February 2023.

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European Pharmaceutical Review

NOVEMBER 18, 2022

Tzield (teplizumab-mzwv), the first drug to help prolong the onset of stage 3 type 1 diabetes in adults and children over eight years old with stage 2 type 1 diabetes, has been approved by the US Food and Drug Administration (FDA). Tzield clinical trials that supported the US Food and Drug Administration approval.

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Pharmaceutical Technology

MAY 10, 2023

Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. The company stated that its findings support the potential for a safe, flexible, effective and convenient oral treatment option for PKU.

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Pharmaceutical Technology

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation for Arcturus Therapeutics’ ARCT-032 for cystic fibrosis.

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Pharmaceutical Technology

AUGUST 16, 2024

The US Food and Drug Administration (FDA) has accepted for priority review the new drug application (NDA) for Ono Pharmaceutical subsidiary Deciphera Pharmaceuticals’ vimseltinib, a treatment for tenosynovial giant cell tumour (TGCT).

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Pharmaceutical Technology

AUGUST 20, 2024

Liquidia has received tentative approval from the US Food and Drug Administration (FDA) for YUTREPIA (treprostinil) inhalation powder.

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European Pharmaceutical Review

JANUARY 13, 2023

AstraZeneca’s Tezspire (tezepelumab) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for self-administration in a pre-filled, single-use auto-injector (AI) pen for severe asthma patients over 12 years. Trial results on the biologic for severe asthma . Regulatory decisions for Tezspire.

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Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth.

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Pharmaceutical Technology

AUGUST 21, 2023

The US Food and Drug Administration (FDA) has granted approval to Regeneron Pharmaceuticals’ EYLEA HD injection 8 mg.

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Pharmaceutical Technology

JUNE 7, 2024

The US Food and Drug Administration (FDA) has criticised the state of Chinese pharma company Jiangsu Hengrui’s facilities in a newly released 483 form.

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Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth.

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Pharmaceutical Technology

AUGUST 12, 2024

IASO Biotherapeutics has secured the US Food and Drug Administration (FDA) approval equecabtagene autoleucel (Eque-cel).

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