FDA Approves Fyarro (sirolimus protein-bound particles) for the Treatment of Malignant Perivascular Epithelioid Cell Tumor (PEComa)

Fyarro is the first and only approved therapy for adults for the treatment of malignant PEComa, an ultra-rare and aggressive form of sarcoma with a strong female predominance LOS ANGELES, Nov. 23, 202

Latest News NDA News 696
Read All

FDA Approves Voxzogo (vosoritide) to Increase Linear Growth in Children with Achondroplasia

SAN RAFAEL, Calif., Nov. 19, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to VOXZO

Latest News NDA News 702
Read All

FDA Approves Besremi (ropeginterferon alfa-2b-njft) for the Treatment of Adults With Polycythemia Vera

BURLINGTON, Mass.--(BUSINESS WIRE) November 12, 2021 --PharmaEssentia Corporation (TPEx: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific pri

Latest News NDA News 1081
Read All

FDA Approves Eprontia (topiramate) Oral Solution for Epilepsy and Preventive Treatment of Migraine

WOBURN, MA, November 8, 2021 – Azurity Pharmaceuticals, Inc. a private specialty pharmaceutical company focused on developing innovative products to meet the unique needs of patients with underserved

Latest News NDA News 953
Read All

FDA Approves Scemblix (asciminib) for the Treatment of Philadelphia Chromosome-Positive Chronic Myeloid Leukemia (Ph+ CML)

Scemblix provides much-needed and long-awaited new option for patients with chronic myeloid leukemia (CML) who suffer with intolerance or inadequate response after at least two previous tyrosine kinas

Latest News NDA News 1386
Read All

FDA Approves Vuity (pilocarpine HCI ophthalmic solution) to Treat Presbyopia (Age-Related Blurry Near Vision)

NORTH CHICAGO, Ill., Oct. 29, 2021 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced the U.S. Food and Drug Administration (FDA) approval of Vuity (pilocarpine HCl ophthalmic s

Latest News NDA News 1008
Read All

FDA Approves Susvimo (ranibizumab) for the Treatment of Wet Age-Related Macular Degeneration (AMD)

South San Francisco, CA -- October 22, 2021 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Susvim

Latest News NDA News 1458
Read All

FDA Approves Xipere (triamcinolone acetonide injectable suspension) for the Treatment of Macular Edema Associated with Uveitis

XIPERE™ is the First and Only Medicine to be Approved in the United States for Delivery via Suprachoroidal Injection, a Method Designed to Facilitate Targeted Delivery of Therapeutic Agents to the Ret

Latest News NDA News 841
Read All

FDA Approves Zimhi (naloxone hydrochloride) Injection for the Treatment of Opioid Overdose

SAN DIEGO, Oct. 18, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) today announced that the U.S. Food and Drug Administration (FDA) has approved Adamis’ Zimhi™ (naloxone HC

Latest News NDA News 814
Read All

FDA Approves Seglentis (celecoxib and tramadol hydrochloride) for the Management of Acute Pain

October 18, 2021 -- The U.S. Food and Drug Administration (FDA) approved Seglentis (celecoxib and tramadol hydrochloride), a proprietary product developed by Esteve Pharmaceuticals' R&D team.

Latest News NDA News 886
Read All

FDA Approves Tyrvaya (varenicline solution) Nasal Spray for the Treatment of the Signs and Symptoms of Dry Eye Disease

PRINCETON, N.J., Oct. 18, 2021 /PRNewswire/ -- Oyster Point Pharma, Inc. (Nasdaq: OYST), today announced that the U.S. Food and Drug Administration (FDA) has approved Tyrvaya (varenicline solution) Na

Latest News NDA News 686
Read All

FDA Approves Rethymic (allogeneic processed thymus tissue-agdc) One-Time Regenerative Tissue-Based Therapy for Pediatric Congenital Athymia

Rethymic is the first and only FDA-approved treatment indicated for immune reconstitution in pediatric patients with congenital athymia Children with congenital athymia are born without a thymus causi

Latest News NDA News 743
Read All
News
- CLINIEXPERT -
Int'l Clinical Service Expert

We are the leader
Because of our professionism