USFDA

BridgeBio Pharma, Inc , a commercial-stage biopharmaceutical company that focuses on genetic diseases and cancers, and Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases owned by Zydus Lifesciences Ltd. announced the European Commission (EC) has granted marketing authorization for NULIBRY  (fosdenopterin) for Injection as the first therapy for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.

Heron Therapeutics, Inc  a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs,  announced that the U.S. Food and Drug Administration (FDA) has approved APONVIE (aprepitant) injectable emulsion, for intravenous use for the prevention of postoperative nausea and vomiting (PONV) in adults.

AnaCipher CRO, based in Hyderabad, is a USFDA inspected clinical research facility and is spread over 40,000 sq. ft area with 98 beds and staffed by experienced professionals providing clinical trial solutions and conducts Bioequivalence and Bioavailability (BA/BE) studies at its facility.

Mallinckrodt plc a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Terlivaz (terlipressin) for injection. Terlivaz is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.

Zydus Lifesciences Limited’s has received approval from the United States Food and Drug Administration (USFDA) to market Lenalidomide Capsules, USP 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. The company has received final approvals for 5 mg, 10 mg, 15 mg and 25 mg strengths and tentative approvals for 2.5 mg and 20 mg strength. USRLD: Revlimid®.

The USFDA rejected Alvotech’s application to approve its biosimilar of AbbVie’s Humira after an inspection of the company’s Reykjavik, Iceland, manufacturing plant.

Alvotech received communication from the U.S. Food and Drug Administration (USFDA) detailing its assessment of the March 2022 inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland and Alvotech’s subsequent written responses to the FDA.

​U.S. Food and Drug Administration (FDA) is alerting health care providers about potential clip lock malfunctions with MitraClip Delivery Systems manufactured by Abbott.

An increased rate of reports of clip lock malfunctions has been observed before and after clip deployment. These events appear to occur in approximately 1.3% of MitraClip procedures and have been observed with all device models, said Abbott.

​With inflation reduction act, Medicare finally having the power to negotiate prescription drug prices with pharmaceutical industries which will affect millions of Americans across all 50 states and the District of Columbia

It will lead to prescription drug costs capped at USD 2,000 annually in Medicare, and will save hundreds of dollars per year on health insurance premiums because of the law.

Pfizer Inc. and BioNTech announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals ages 12 years and older.

And on the same day,  Moderna, Inc. has also received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Omicron-targeting bivalent COVID-19 booster vaccine.