Tag: FDA Approved

FDA Approved Eli Lilly Reyvow Tablets for Acute Treatment of Migraine

The U.S. Food and Drug Administration approved Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance)...

FDA Granted Approval to Scenesse

The U.S. Food and Drug Administration granted approval to Scenesse (afamelanotide) to increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from e...

FDA Approved Dimethyl Fumarate Delayed-Release Capsules

glenmark
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Dimethyl Fumarate Delayed-Release Capsules, 120 mg ...

FDA Approved Beovu® Injection

Novartis announced that the U.S. Food and Drug Administration (FDA) approved Beovu® (brolucizumab) injection, also known as RTH258 for the treatment of wet age-related macular degeneration (AMD). Beov...

FDA Approved AKLIEF® Cream

Galderma, a global leader focused on meeting the world's increasing skin health needs, announced that the U.S. Food and Drug Administration (FDA) approved AKLIEF® (trifarotene) Cream, 0.005% for the t...

FDA Approved Self-Administration of AstraZeneca Fasenra

astrazeneca
AstraZeneca announced that the US Food and Drug Administration (FDA) has approved the self-administration of Fasenra (benralizumab) in a pre-filled, single-use auto-injector (the Fasenra Pen). The ...

FDA Approved Gilead’s Descovy

The U.S. Food and Drug Administration approved Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) in at-risk adults and adolescents weighing at least 35kg for HIV-1 pre-exposure prophylaxi...

FDA Approved Rituxan Injection to Treat Granulomatosis with Polyangiitis

The U.S. Food and Drug Administration approved Rituxan (rituximab) injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2 years of age and older in ...

FDA Approved Roche’s Rituxan®

Roche announced that the U.S. Food and Drug Administration (FDA) has approved Rituxan® (rituximab), in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis (GPA) and...

FDA Approved Abbott’s Proclaim XR™ Recharge-Free Neurostimulation System

abbott
Abbott announced the U.S. Food and Drug Administration (FDA) has approved the company's Proclaim XR™ recharge-free neurostimulation system for people living with chronic pain. The Proclaim XR platf...

FDA Approved DARZALEX® Combo for Multiple Myeloma Treatment

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approval of DARZALEX® (daratumumab) in combination with bortezomib, thalidomide and ...

FDA Granted Approval of AbbVie’s MAVYRET®

abbvie
AbbVie, a research-based global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted approval of MAVYRET® (glecaprevir/pibrentasvir) to shorten the once-da...

FDA Approved Jynneos Smallpox and Monkeypox Vaccine

The U.S. Food and Drug Administration announced the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the prevention of smallpox and monkeypox disease in adults 18 years o...

Novo Nordisk Rybelsus Approved by FDA

The U.S. Food and Drug Administration approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise. Rybelsus is t...

Roche’s Individual Blood Test Approved by FDA

Roche announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the cobas Babesia test for use on the cobas 6800/8800 Systems for individual blood donation testing. ...

FDA Approved ERLEADA® for Metastatic Castration-Sensitive Prostate Cancer Treatment

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved ERLEADA® (apalutamide) for the treatment of patients with metastat...