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Novo Nordisk ends Hims & Hers deal over Wegovy knockoffs
The conclusion of the collaboration comes as the drug maker cites illegal sales of compounded knockoff weight loss drugs and expresses growing concerns over patient safety.
Novo Nordisk seeks FDA approval for Wegovy weight loss pill
If the administration signs off on the application, the company’s experimental once-daily version will become the first oral GLP-1 for weight loss.
FDA awards Cellares first-of-its-kind designation
Company officials say that the "unprecedented designation" acknowledges the Cell Shuttle’s ability to automate and reliably manufacture cell therapies, representing a significant step forward in the advanced manufacturing of cell therapies.
NJ center offers 1st FDA-approved treatment for eye disease
A Whippany vision facility said it's the first in New Jersey to use the Valeda Light Delivery System – “a game-changer" for patients with dry age-related macular degeneration.
FDA alerts NJ pharma over ‘misleading’ cancer drug claims at conference
According to the agency, the 15-year-old company only presented efficacy claims for its branded medication and did not include any warnings or precautions for the tablets at a tradeshow.
J&J’s ketamine-based drug approved as standalone treatment
"Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them. For too long, health care providers have had few options to offer patients much-needed symptom improvement," commented Johnson & Johnson Head of Neuroscience Bill Martin.
FDA officially bans Red No. 3 food dye over cancer risks
The artificial coloring has long been used in the U.S. to give a bright red or pink hue to certain foods, drinks and ingested medications.
J&J seeks expanded FDA approval for ketamine-based Spravato
The update would clear the nasal spray as a standalone treatment for adults with treatment-resistant depression.
FDA clears Curio’s postpartum depression PDT
Eight-week course MamaLift Plus is the first prescription digital therapeutic cleared for PPD by the agency.
FDA probe into China-made plastic syringes has no impact on BD, embecta
Franklin Lakes-headquartered BD and spinoff embecta, based in Parsippany, are assuring the public that their devices are manufactured domestically and safe.
FDA grants expanded approval for Bristol Myers Squibb anemia therapy
“The approval of Reblozyl in the first-line treatment of anemia for patients with lower-risk MDS represents a crucial step in making transfusion independence possible for more patients," said Tracey Iraca, executive director of the MDS Foundation.
Alzheimer’s drug Leqembi receives full FDA approval
The breakthrough treatment from Eisai and Biogen is the first and only approved to show reduced rates of disease progression and to slow cognitive and functional decline in adults with the disease.
