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 study involves patients aged 1 to 55 years who are allergic to peanuts and at least two other common foods.

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PharmaVoice

FEBRUARY 9, 2023

FDA’s food program is in for a major overhaul — here’s why pharma should pay attention.

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Fierce Pharma

JANUARY 22, 2024

Food and Drug Administration’s crosshairs, Reuters first reported. Following a July inspection, the FDA has uncovered eight new production deficiencies at Eli Lilly's Branchburg production plant. Eli Lilly’s beleaguered manufacturing site in Branchburg, New Jersey, is back in the U.S.

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Pharmaceutical Technology

FEBRUARY 20, 2024

Xolair is the first FDA-approved drug to reduce allergic reactions in people with one or more food allergies, as per Roche’s announcement.

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Food FDA 94

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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World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. The FDA gave approval to a medication despite a strong NO vote from their advisory panel of scientific advisers. Where to start? John Carroll, Endpoints.

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Nixon Gwilt Law

MARCH 6, 2025

On February 21, 2025 , the FDA officially determined that the shortage of semaglutide injection products has been resolved. When the FDA determines the drug shortage is resolved, the normal restrictions on compounding will apply once again. Those impacted must navigate critical regulatory changes now in play for compounded semaglutide.

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Infuse Medical

JULY 4, 2024

If so, it is important to understand the regulatory requirements of the FDA. Do you know the FDA is the Food and Drug Administration? It is essential to understand the FDA’s definition of a medical device. Let’s see FDA regulations for medical device training.

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PharmaVoice

JANUARY 23, 2024

What started as an examination of the Human Foods Program has expanded into an agency-wide overhaul.

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Food FDA 173

pharmaphorum

OCTOBER 4, 2024

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

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Food and Drug Administration FDA Food 111

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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Food and Drug Administration FDA Food 105

Pharmaceutical Technology

DECEMBER 20, 2023

The FDA accepted the filing based on NIH-funded Phase III trial interim results, with an approval decision expected in Q1 2024

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Food FDA 97

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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Food and Drug Administration FDA Food 98

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

SEPTEMBER 13, 2024

The US Food and Drug Administration (FDA) has approved Roche's Tecentriq Hybreza, a subcutaneous anti-PD-(L)1 cancer immunotherapy.

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Food and Drug Administration FDA Food 98

World of DTC Marketing

DECEMBER 13, 2021

11 of the 12 cancer drugs that the Food and Drug Administration approved in 2012 were priced at more than $100,000 per year. The lifestyle choices we make, the foods we eat, and our physical activity levels impact our cancer risk. Compare that with, say, treating heart disease. Research shows most cancers are preventable.

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Food and Drug Administration Food Medical Medicine 55

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED). It is the first and only prescription eye drop to receive FDA approval to treat DED that targets tear evaporation directly.

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Food and Drug Administration FDA Prescription Food 133

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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Food and Drug Administration FDA Food 98

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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Food and Drug Administration Medical FDA Food 105

pharmaphorum

JANUARY 16, 2025

The FDA has banned the use of a red dye used in oral medicines, foods, and dietary supplements, more than 30 years after it was linked to cancer.

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Medicine FDA Food 98

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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Food and Drug Administration FDA Food 98

Pharmaceutical Technology

OCTOBER 17, 2024

The company’s keratoconus medication, Epioxa, was effective in a Phase III trial, with plans to file for submission with the US Food and Drug Administration (FDA).

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Food and Drug Administration FDA Food Medical 98

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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Food and Drug Administration FDA Food 98

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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Food and Drug Administration FDA Food 98

PharmaTimes

NOVEMBER 23, 2023

ADP101 is an oral immunotherapy to treat multi-food and single-food allergies - News - PharmaTimes

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World of DTC Marketing

MARCH 23, 2022

Accelerated Approval was developed in 1992 in response to the HIV/AIDS crisis and has led to expedited drug and biologic approvals in several disease areas across the FDA. The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012.

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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

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 Patients 119

World of DTC Marketing

FEBRUARY 2, 2022

While some doctors have been eager to start prescribing the newly approved drug, others had criticized the FDA for clearing the drug before studies proved it works. Food and Drug Administration on Biogen Inc.’s ” A physician on STAT News wrote, “the consequences of FDA approval are as disturbing as they are vast. .’s

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European Pharmaceutical Review

MARCH 20, 2024

The US Food and Drug Administration (FDA) has approved gene therapy Lenmeldy (atidarsagene autotemcel) as the first treatment for children with early-onset metachromatic leukodystrophy (MLD). Deficiency of the enzyme arylsulfatase A (ARSA) and subsequent buildup of sulfatides in the cells is considered to cause MLD, FDA elucidated.

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European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US.

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pharmaphorum

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.

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FDA Food and Drug Administration Patients Food 119

Pharmaceutical Technology

AUGUST 10, 2022

The US Food and Drug Administration (FDA) has granted Fast-Track designation to Relmada Therapeutics’ REL-1017 as a single agent to treat major depressive disorder (MDD). The post FDA grants Fast-Track status for Relmada’s major depressive disorder therapy appeared first on Pharmaceutical Technology.

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Food and Drug Administration FDA Safety Food 119

European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. Clinical trials of the FDA approved Rykindo ®. The post FDA approves long-acting injectable for schizophrenia and bipolar disorder appeared first on European Pharmaceutical Review.

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World of DTC Marketing

NOVEMBER 24, 2021

Food and Drug Administration rose to nearly $15,000 from about $6,000, the data showed. The FDA on Tues­day ap­proved Aa­di Bio­science’s first drug and the first treat­ment ap­proved specif­i­cal­ly for pa­tients with an ul­tra-rare and ag­gres­sive form of sar­co­ma that oc­curs most­ly in women.

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World of DTC Marketing

DECEMBER 2, 2021

GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. Since when is consumer behavior ever scientific? Higher numeracy was associated with better gist and verbatim recall.” ” Uh…no.

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European Pharmaceutical Review

OCTOBER 25, 2023

The US Food and Drug Administration (FDA) has approved a new therapy for adults with relapsed or refractory (R/R) myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation, a rare type of blood cancer. The small molecule treatment Tibsovo (ivosidenib) is the first targeted therapy approved for this indication.

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