Pharmaceutical Commerce

DECEMBER 20, 2023

If the FDA approves the sBLA for Xolair, it would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure.

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Food FDA 52

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 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

Legacy MEDSearch

OCTOBER 2, 2023

Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse ® ) for the subcutaneous delivery of EMPAVELI ® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. Food and Drug Administration (FDA) Approval appeared first on Legacy MedSearch | Medical Device Recruiters.

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Food and Drug Administration Food FDA Recruitment 52

Pharmaceutical Technology

NOVEMBER 23, 2023

The fast track designation for the paediatric multi-food allergy therapy ADP101 was based on the Phase I/II data.

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Food FDA 59

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

APRIL 23, 2024

The US Food and Drug Administration (FDA) has granted approval for ImmunityBio's ANKTIVA, plus Bacillus Calmette-Guérin (BCG), for treating patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

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Food and Drug Administration FDA Food Patients 52

Pharmaceutical Technology

APRIL 19, 2024

The US Food and Drug Administration (FDA) has granted approval for Takeda’s ENTYVIO subcutaneous (SC) administration as a maintenance therapy to treat adults with moderately to severely active Crohn's disease (CD).

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Food and Drug Administration FDA Food 59

PharmExec

FEBRUARY 16, 2024

Novartis’ and Roche’s Xolair (omalizumab) is indicated to treat severe allergic reactions after accidental exposure to one or more foods in individuals aged one year and above.

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Food Patients FDA 52

Pharmacy Times

NOVEMBER 22, 2023

The designation allows expedited development of ADP101 as a treatment for food allergy in children ages 4 to 17 with confirmed allergy to 1 or more of the 15 foods in the drug product.

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Food FDA 55

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

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

Pharmaceutical Technology

MARCH 20, 2024

The US Food and Drug Administration (FDA) has granted approval for Boehringer Ingelheim's SPEVIGO injection to treat generalised pustular psoriasis (GPP).

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Food and Drug Administration FDA Food 59

PharmExec

NOVEMBER 27, 2023

Manufacturer states that novel drug is the most advanced multi-food oral immunotherapy drug candidate currently in development.

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Food Manufacturing FDA 52

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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FDA Food and Drug Administration Manufacturing Pharmaceutical manufacturing 95

Pharmacy Times

FEBRUARY 16, 2024

This marks omalizumab’s fourth FDA-approved indication for allergic and inflammatory conditions, such as severe persistent allergic asthma, with its initial approval being in 2003.

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Food FDA Patients 57

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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Food and Drug Administration Food FDA 246

MedCity News

SEPTEMBER 5, 2023

Palforzia was the first FDA-approved drug for peanut allergy, but its sales were hampered by the Covid-19 pandemic. Peanut allergy therapy Palforzia, which Nestlé acquired in a multi-billion dollar deal, has been sold to allergy product company Stallergenes Greer.

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Pharmaceutical Technology

APRIL 2, 2024

Alexion has received the approval of the US Food and Drug Administration (FDA) for Voydeya as an add-on therapy.

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Food and Drug Administration FDA Food 52

Pharmaceutical Technology

MARCH 6, 2024

The US Food and Drug Administration (FDA) has granted approval for Sandoz’s Wyost and Jubbonti, two biosimilars of denosumab.

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Food and Drug Administration FDA Food 52

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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Food and Drug Administration Pharmaceutical FDA Food 98

Pharmaceutical Technology

AUGUST 7, 2023

Iveric Bio, an Astellas company, has received clearance from the US Food and Drug Administration (FDA) for IZERVAY.

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Food and Drug Administration FDA Food 98

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

PharmaTech

FEBRUARY 3, 2023

A realignment of the Office of Regulatory Affairs would create a focus on “critical activities” for ensuring the safety of foods and other regulated products, including drugs, biologics, and medical devices.

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Food Safety FDA Medical 52

Pharmaceutical Technology

JANUARY 25, 2024

Theratechnologies has received a CRL from the US Food and Drug Administration (FDA), denying approval for its F8 formulation of tesamorelin.

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Food and Drug Administration FDA Food 52

Pharmatutor

FEBRUARY 2, 2023

FDA Inspections - Overview admin Thu, 02/02/2023 - 13:52 FDA Inspection is a regulatory process conducted by the United States Food and Drug Administration (FDA) to evaluate the compliance of food and drug establishments with FDA regulations and standards.

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Food and Drug Administration FDA Food Safety 52

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 114

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. US sales of Stelara totalled $6.4

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Food and Drug Administration FDA Side effects Safety 93

European Pharmaceutical Review

OCTOBER 17, 2023

The US Food and Drug Administration (FDA) has published draft guidance on how it intends to use alternative tools for assessing drug manufacturing facilities identified in pending marketing applications. Fundamentally, this approach will establish whether facilities meet applicable requirements for FDA approval and licensure decisions.

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FDA Food and Drug Administration Manufacturing Food 98

Legacy MEDSearch

MARCH 7, 2024

Food and Drug Administration (FDA) announced the clearance of Dexcom’s device, marking it as the first continuous glucose monitor available over the counter. The post FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor appeared first on Legacy MEDSearch. On March 5, the U.S. Are you hiring?

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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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Food and Drug Administration FDA Prescription Food 98

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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Pharmaceutical Technology

NOVEMBER 13, 2023

On 8 November, Takeda announced it had received US Food and Drug Administration (FDA) approval for its oral Fruzaqla (fruquintinib) as a third-line treatment for adults with metastatic colorectal cancer (mCRC).

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Food and Drug Administration FDA Food 52

Pharmaceutical Technology

JANUARY 22, 2023

Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients.

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Food and Drug Administration FDA Food Patients 105

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review. We look forward to working with the FDA to bring this potential first-in-class AKT inhibitor to patients as quickly as possible.”

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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. POLARIS AR is pleased to announce today that their STELLAR Knee has received 510(k) clearance from the U.S.

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Food and Drug Administration Food Recruitment Medical 52

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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