Remove Drugs Remove FDA Approval Remove Treatment
article thumbnail

FDA Approves Polypill Widaplik for Hypertension

Drugs.com

Food and Drug Administration has approved Widaplik (telmisartan, amlodipine, and indapamide) for the treatment of hypertension in adults.The combination pill is the first and only FDA-approved triple combination. WEDNESDAY, June 11, 2025 -- The U.S.

article thumbnail

FDA Approves Once-Monthly Andembry for Hereditary Angioedema

Drugs.com

Food and Drug Administration has approved Andembry (garadacimab-gxii) as the only treatment targeting factor XIIa for prophylactic use to prevent attacks of hereditary angioedema (HAE). FRIDAY, June 20, 2025 -- The U.S. According to the Mayo.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA Approves Topical Foam for Plaque Psoriasis of the Scalp and Body

Drugs.com

Food and Drug Administration has approved Zoryve (roflumilast) topical foam 0.3 percent for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older.Through. TUESDAY, May 27, 2025 -- The U.S.

article thumbnail

FDA Approves Label Updates for Bristol Myers Squibb Cell Therapies, Removes REMS

The Pharma Data

FDA Approves Streamlined Monitoring Requirements and REMS Program Removal for Bristol Myers Squibb’s CAR T Cell Therapies Breyanzi and Abecma, Marking Milestone Toward Expanding Access to Cancer Treatment In a significant regulatory development, Bristol Myers Squibb announced that the U.S.

article thumbnail

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog: Drug Discovery

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

article thumbnail

FDA Approves CSL’s Andembry First Once-Monthly Prophylactic HAE Treatment Targeting Factor XIIa

The Pharma Data

FDA Approves ANDEMBRY (garadacimab-gxii) The First Once-Monthly Prophylactic HAE Therapy Targeting Factor XIIa CSL a leading biotechnology company with a strong track record of developing innovative medicines for patients with rare and serious disorders, today announced that the U.S. when directly comparing ANDEMBRY to placebo.

article thumbnail

FDA Approves Tablet Form of BeOne’s BRUKINSA® for All Indications

The Pharma Data

FDA Approves Tablet Formulation of BeOne’s BRUKINSA® for All Approved Indications, Offering Greater Convenience for Patients with B-cell Cancers BeOne Medicines Ltd. Food and Drug Administration (FDA). a global oncology-focused biopharmaceutical company, has received a significant regulatory milestone from the U.S.