Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

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Pharmaceutical Technology

JUNE 9, 2023

Rocket Pharmaceuticals has received fast track and orphan drug designations for RP-A601 from the US Food and Drug Administration (FDA) to treat plakophilin-2-related arrhythmogenic cardiomyopathy (PKP2-ACM). In April 2023, the FDA approved the investigational new drug (IND) application for RP-A601 to begin a Phase I clinical trial.

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Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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Marketing FDA Food and Drug Administration Pharmaceutical 97

pharmaphorum

JULY 6, 2022

The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely access with robust safety? They found that the FDA approved 85 (95%) of the drugs before the EMA, with the latter clocking up a median delay of 241 (150-370) days.

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eMediWrite

JULY 13, 2023

Central Drugs Standard Control Organisation (earlier known as Drugs Controller General of India) are essential to the pharmaceutical production process. They play a crucial role in assuring the efficacy and safety of products given to patients. A company’s systems transparency may also be shown by such data.

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Pharmaceutical Commerce

FEBRUARY 15, 2024

There were no safety or efficacy issues identified in the FDA complete response letter for Lymphir, with no additional trials required.

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European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). The post FDA approves first Stelara biosimilar, Wezlana appeared first on European Pharmaceutical Review. Like Stelara, the most serious known side effect of Wezlana is infection.

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Food and Drug Administration FDA Side effects Safety 91

European Pharmaceutical Review

JUNE 26, 2023

US Food and Drug Administration (FDA) has published its first draft guidance presenting considerations to the pharmaceutical industry for designing clinical trials for psychedelic drugs. FDA’s draft guidance refers to psychedelics as “classic psychedelics”. These should be submitted latest 23 Aug 2023 to be considered.

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Food and Drug Administration FDA Safety Food 86

European Pharmaceutical Review

OCTOBER 18, 2023

The US Food and Drug Administration (FDA) has approved XPHOZAH ® (tenapanor), the first and only phosphate absorption inhibitor. The post First-in-class phosphate absorption inhibitor approved by FDA appeared first on European Pharmaceutical Review.

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Food and Drug Administration FDA Food Safety 111

European Pharmaceutical Review

DECEMBER 20, 2023

The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental Biologics License Application for Xolair ® (omalizumab) for treatment of children and adults with food allergies. The FDA is expected to decide on approval of Xolair for patients with food allergies in the first quarter of 2024.

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Food Food and Drug Administration FDA Patients 96

European Pharmaceutical Review

JANUARY 20, 2023

The US Food and Drug Administration (FDA) has issued a complete response letter for the accelerated approval submission of donanemab for early Alzheimer’s, Eli Lilly and Company revealed. The safety profile of donanemab was initially reported from the TRAILBLAZER-ALZ trial in the New England Journal of Medicine.

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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. Novartis and Incyte Corp’s Jakafi was the first FDA-approved drug for the treatment of myelofibrosis in November 2011.

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European Pharmaceutical Review

SEPTEMBER 29, 2023

The US Food and Drug Administration (FDA) has approved Exxua (gepirone hydrochloride extended-release tablets) for adults with major depressive disorder ( MDD ). Dr Stephen Kramer, CEO of Fabre-Kramer Pharmaceuticals declared that the approval of Exxua “represents an important milestone in the treatment of MDD”.

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Pharmaceutical Technology

FEBRUARY 20, 2023

The US Food and Drug Administration (FDA) has granted approval for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). Syfovre’s safety profile is well-demonstrated after approximately 12,000 injections over 24 months.

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Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. It also achieved non-inferiority of MACE compared to ESA control, in the primary safety analysis of the ITT population.

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Food and Drug Administration FDA Safety Food 105

Pharmaceutical Technology

MAY 4, 2023

Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for KALYDECO (ivacaftor) to treat children with cystic fibrosis (CF) aged between one and four months. This cohort showed a safety profile identical to that found in older children and adults.

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Food and Drug Administration FDA Safety Medicine 98

Pharmaceutical Technology

APRIL 17, 2023

On 14 April 2023, experts from the US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) voted largely in favour of the potential approval of Otsuka’ s and Lundbeck Pharmaceuticals’ Rexulti for the treatment of agitation associated with Alzheimer’s dementia (AAD). Rexulti is an atypical antipsychotic.

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Pharmaceutical Technology

AUGUST 8, 2022

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. Enhertu-treated subjects had a median overall survival (OS) of 23.4 months compared with 16.8

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Food and Drug Administration FDA Safety Food 105

Pharmaceutical Technology

AUGUST 12, 2022

The US Food and Drug Administration (FDA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (fam-trastuzumab deruxtecan-nxki) to treat unresectable or metastatic non-small cell lung cancer (NSCLC) in adults. According to the interim efficacy data from a pre-specified patient cohort, a 5.4

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Pharmaceutical Technology

SEPTEMBER 6, 2022

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. It also boosts the drug’s safety, tolerability and efficacy. Updated using the pre|CISION technology, AVA6000 is a kind of generic chemotherapy doxorubicin.

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Food and Drug Administration FDA Safety Food 98

Pharmaceutical Technology

FEBRUARY 22, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for Biohaven ’s new anti-myostatin adnectin, taldefgrobep alfa, to treat spinal muscular atrophy (SMA). Previously, the US FDA granted orphan drug designation to taldefgrobep to treat SMA, a rare and progressively debilitating motor neuron disease.

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Food and Drug Administration FDA Food Safety 98

Pharmaceutical Technology

AUGUST 8, 2022

The US Food and Drug Administration (FDA) has granted approval for a supplemental New Drug Application (sNDA) of Orion and its partner Bayer ’s Nubeqa (darolutamide) plus docetaxel to treat metastatic hormone-sensitive prostate cancer (mHSPC) patients.

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Food and Drug Administration FDA Safety Food 98

Pharmaceutical Technology

JULY 1, 2022

Pfizer has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for Paxlovid (nirmatrelvir tablets and ritonavir tablets) to treat Covid-19 patients at increased disease progression risk. We look forward to working with the FDA toward full regulatory approval for Paxlovid.”.

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Food and Drug Administration FDA Safety Food 105

European Pharmaceutical Review

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has approved Hemgenix (etranacogene dezaparvovec), the first gene therapy for adults with Haemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening haemorrhage, or have repeated, serious spontaneous bleeding episodes.

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European Pharmaceutical Review

JANUARY 30, 2023

Jaypirca (pirtobrutinib) has been approved by the US Food and Drug Administration (FDA), making it the first and only FDA-approved non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor. The safety of Jaypirca was evaluated in 128 patients with MCL: 36 percent were exposed for six months or longer.

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European Pharmaceutical Review

MAY 2, 2023

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. The FDA’s regulatory requirements for investigations of medical products are the same for DCTs and traditional site-based clinical trials.

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Pharmaceutical Technology

JANUARY 19, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for Avidity Biosciences’ AOC 1020 to treat facioscapulohumeral muscular dystrophy (FSHD). We look forward to working collaboratively with the FDA to bring the first RNA therapy directly targeting DUX4 to patients as quickly as possible.”

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Food and Drug Administration FDA Food Safety 98

European Pharmaceutical Review

DECEMBER 2, 2022

Rigel Pharmaceuticals, Inc. has announced the US Food and Drug Administration (FDA) has approved its oral drug Rezlidhia (olutasidenib) for adults with relapsed or refractory (R/R) acute myeloid leukaemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. Clinical safety data of Rezlidhia for AML.

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Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted a combination of AstraZeneca and MSD ’s Lynparza (olaparib), with standard therapies for treating BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Safety and tolerability were in line with that observed in prior trials and the known profiles of the medicines.

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Food and Drug Administration FDA Food Safety 97

European Pharmaceutical Review

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Adstiladrin (nadofaragene firadenovec-vncg) as the first gene therapy for non-muscle-invasive bladder cancer (NMIBC) in adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive with carcinoma in situ (CIS) with or without papillary tumours. Clinical study of Adstiladrin.

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European Pharmaceutical Review

MARCH 5, 2024

The US Food and Drug Administration (FDA) recently highlighted data integrity issues concerning premarket submissions received for medical devices. Consequently, because “it calls into question the data integrity of the entire file”, FDA asserted that is unable to rely on the data to grant marketing authorisation.

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Medical Manufacturing Food and Drug Administration Safety 85

Pharmaceutical Technology

MARCH 30, 2023

The US FDA has revealed its detailed budget proposal for FY2024, which would require pharma companies to name their active pharmaceutical ingredient (API) suppliers, restart President Biden’s Cancer Moonshot, inject cash into amyotrophic lateral sclerosis (ALS) research, and enforce stricter rules around manufacturing, recalls, and shortages.

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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). A clinical trial evaluated the safety and efficacy of Tzield in 76 patients with stage 2 type 1 diabetes.

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Food and Drug Administration FDA Side effects Food 95

Pharmaceutical Commerce

NOVEMBER 1, 2023

The FDA granted Wezlana with interchangeable designation after clinical trials found no clinically significant differences in safety and efficacy for the indicated conditions across multiple inflammatory diseases.

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Pharmaceutical Technology

JULY 27, 2022

The US Food and Drug Administration (FDA) has granted priority review for Biogen ’s New Drug Application (NDA) for investigational drug, tofersen, to treat superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). The FDA also plans to hold an advisory committee meeting for the NDA.

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Food and Drug Administration FDA Food Safety 98

Pharmaceutical Technology

APRIL 21, 2023

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. Quizartinib had a 11.3%

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Food and Drug Administration FDA Safety Prescription 98

Pharmaceutical Technology

JULY 19, 2022

The US Food and Drug Administration (FDA) has granted approval for Incyte’s Opzelura (ruxolitinib) cream 1.5% With the latest development, Opzelura has became the first treatment for repigmentation in patients with vitiligo to receive FDA approval. Opzelura is a topical formulation of a Janus kinase (JAK) inhibitor.

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Food and Drug Administration FDA Food Safety 116