Drug Administration Articles & Analysis

The American Food and Drug Administration (FDA) has granted Orphan Drug Designation to ZENEO® Midazolam for the treatment of status epilepticus (epileptic seizure lasting longer than 5 minutes). The orphan designation for ZENEO® Midazolam improves Crossject’s international visibility and gives impetus to its current negotiations for partnerships with pharmaceutical laboratories. ...

By Crossject

We are happy to announce that on December 15, 2021, Metaltronica SpA has received 510(k) clearance from the U.S. Food and Drug Administration for its Helianthus Full-Field Digital Mammography ...

By Metaltronica S.p.A.

Spanish medical device innovator Nuubo (https://www.nuubo.com) today announced it has received United States Food and Drug Administration (FDA) 510 (k) clearance to market its Nuubo System, a disruptive wireless, textile-based ambulatory electrocardiogram (aECG) technology that enables mid and long-term monitoring for cardiac arrhythmia ...

By Nuubo

(BusinessWire, North Andover, Massachusetts), MindChild Medical, Inc. today announced that it has received clearance for its Pre-Marketing Notification (510(k)) from the US Food and Drug Administration (FDA) for its MERIDIAN™ M110 non-invasive fetal heart monitor. MindChild anticipates entering the US market with MERIDIAN now that it has received the FDA clearance. ...

By Mindchild Medical, Inc.

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Bivalirudin injection, 250 mg/vial. The approved ANDA is a generic equivalent to the reference listed drug (RLD) product Angiomax® Injection of The Medicines Company. The estimated market size Bivalirudin injection is US$ 101 ...

By Aurobindo Pharma Limited

Each year, the Food and Drug Administration (FDA) approves many generic drugs that treat a wide variety of conditions and help consumers save money. To read about recent significant FDA approvals for generic medications, go to http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm236544.htm. Sign up for e-mail notices of new FDA Consumer Updates at: ...

By CSRwire - Corporate Social Responsibility Newswire

Lipella Pharmaceuticals’ LP-310 asset has the potential to become the first oral drug treatment for oral lichen planus Pittsburgh, PA – (May 11, 2021) – Lipella Pharmaceuticals Inc., a clinical stage pharmaceutical company based in Pittsburgh, PA, announced today that the company has successfully concluded a Type B pre-Investigational New Drug (IND) meeting communication with ...

By Lipella Pharmaceuticals Inc.

Alcoholic beverages to which caffeine has been added as a separate ingredient have raised health concerns at the Food and Drug Administration (FDA) as well as in other federal, state, and local agencies. Find out more about these products, and why FDA has sent warning letters to four firms that make them, at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm233987.htm. Sign up for e-mail ...

By CSRwire - Corporate Social Responsibility Newswire

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture Azithromycin tablets 250 mg and 500 mg. Azithromycin tablets are an AB-rated generic equivalent of Pfizer Inc’s Zithromax tablets. The product will be launched in July 2018. Azithromycin tablets are indicated for the treatment of ...

By Aurobindo Pharma Limited

(BusinessWire, North Andover, Massachusetts), MindChild Medical, Inc. today announced that it has received clearance for a 510(k)Pre-Marketing Notification Application from the US Food and Drug Administration (FDA) for its MERIDIAN Model M100 non-invasive Fetal Heart Monitor1,2. MindChild anticipates entering the US market with MERIDIAN following the FDA pre-market clearance. Additional ...

By Mindchild Medical, Inc.

Crossject and the US Department of Defense - DOD - (who is in charge of chemical, biological, radiological and nuclear defense – JPM CBRN Medical) have signed a cooperative research and development agreement for Zeneo® Midazolam. « We are really happy to have signed this cooperative research and development agreement with the US Department of Defense (DOD), after their audit when ...

By Crossject

Bright Path Laboratories, Inc. (privately held) 3-year-old startup contract manufacturer – with offices in both Charlotte and Santa Fe, N.M. – recently got a strong show of support from The U.S. Food and Drug Administration for its patented spinning-tube-in-tube (STT) continuous-flow reactor. The agency accepted the system, the only one of its kind that manufactures active ...

By Bright Path Laboratories

Aurobindo Pharma Limited is pleased to announce that its joint venture company, Eugia Pharma Specialities Limited, has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Methotrexate tablets, 2.5 mg. Methotrexate tablets are generic version of Dava Pharmaceuticals’ Rheumatrex Tablets. The product will be launched in March 2020. The ...

By Aurobindo Pharma Limited

The FDA conforming WinASPECT PLUS software for the SPECORD PLUS series of Analytik Jena offers the ideal tool needed for efficient analysis in all fields, from R&D to production, from quality control to lab routine. Industries like pharmacy, biotechnology and medicine are subject to strict requirements of regulatory authorities. The Food and Drug Administration (FDA) is the supreme authority ...

By Analytik Jena - an EndressHauser Company

Koios Medical, Inc has received 510(k) clearance from the U.S. Food and Drug Administration for Koios DS (Decision Support) Breast 2.0, a new version of its machine learning based platform that assists physicians in the classification and diagnosis of breast cancer. The software offers a proprietary alignment to BI-RADS® for any lesion analyzed and is available connected to PACS and/or ...

By Koios Medical, Inc.

Basel, March 23, 2022 — Novartis announced today that the US Food and Drug Administration (FDA) approved PluvictoTM (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) for the treatment of adult patients with a certain type of advanced cancer called prostate-specific membrane antigen–positive metastatic castrationresistant prostate cancer (PSMA-positive ...

By Advanced Accelerator Applications SA

PHILADELPHIA, March 01, 2022 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on the discovery and development of targeted cell therapies for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for MuSK-CAART, or muscle-specific kinase (MuSK) chimeric ...

By Cabaletta Bio, Inc.

Camurus AB (NASDAQ STO: CAMX) today announced that its US licensee Braeburn has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its updated New Drug Application (NDA) for Brixadi (buprenorphine) extended-release injections for the treatment of opioid use disorder. The CRL is a result of continued quality related deficiencies at Braeburn’s US ...

By Camurus AB

Schlieren (Zurich), Switzerland, April 27, 2022 – Kuros Biosciences (SIX: KURN), a leader in next generation bone graft technologies, today provided a first-quarter business update, showing a significant acceleration in product sales of its Medical devices segment. Medical devices sales increased 102% in Q1 2022 compared to Q1 2021. The U.S. Food and Drug Administration (FDA) cleared ...

By Kuros Biosciences A.G.

Schlieren (Zurich), Switzerland, April 27, 2022 – Kuros Biosciences (SIX: KURN), a leader in next generation bone graft technologies, today provided a first-quarter business update, showing a significant acceleration in product sales of its Medical devices segment. Medical devices sales increased 102% in Q1 2022 compared to Q1 2021. The U.S. Food and Drug Administration (FDA) cleared ...

By Kuros Biosciences A.G.