
Aimed has also sought Nadda’s “urgent intervention” and “roll back the unfair discriminatory notification”.
The FDA reviewed this test under the FDA’s De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk…
The approval is only for the 2.5mg tablet. Xarelto is also available in 10mg, 15mg, and 20mg tablets, as well…
Certain batches of MadeGood granola bars were recalled due to the potential presence of a piece of metal in the…
To date, the FDA has approved 65 biosimilar products for a variety of health conditions.
Last month, the European Medicines Agency allowed Novo to add risk reduction for events related to kidney disease to the…
Patients should stop taking glatiramer acetate and seek immediate medical attention by going to an emergency room or calling 911…
Recently in 2024, the agency received a report involving a patient who received the nasal solution as an injection.
Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US$ 145.3 million for twelve months ending…
The FDA would provide manufacturers with appropriate time to either reformulate drugs containing oral phenylephrine or remove such drugs from…
Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, and 240 mg have an estimated market size of US$ 28.2…
The FDA granted Hympavzi Orphan Drug designation for this application.
According to USFDA, as with all rapid antigen tests, which generally have lower sensitivity than molecular tests, there is a…
Alembic has a cumulative total of 216 ANDA approvals (189 final approvals and 27 tentative approvals) from USFDA.
Schizophrenia causes persistent delusions and hallucinations and significantly impairs the way patients perceive reality.
Patients should stop taking Veozah immediately and contact the doctor who prescribed the medicine if they experience signs and symptoms…
The agency recently issued a warning letter to SoloVital for selling Umary. In July 2024, Main Products and SoloVital recalled…
The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ – II, India.