FDA Approves Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% for the Treatment of Presbyopia

PONTE VEDRA, Fla., Oct. 18, 2023 /PRNewswire/ -- Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on reshaping vision possibilities, today announced that the U.S. Food and

Latest News NDA News 502
Read All

FDA Approves Bimzelx (bimekizumab-bkzx) for the Treatment of Adults with Moderate to Severe Plaque Psoriasis

Brussels (Belgium), 18 OCTOBER 2023 – UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Bimzelx® (bimekizumab-bkzx) for the treatme

Latest News NDA News 626
Read All

FDA Approves Velsipity (etrasimod) for Adults with Moderately to Severely Active Ulcerative Colitis (UC)

NEW YORK--(BUSINESS WIRE) October 13, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Velsipity™ (etrasimod), an oral, once-daily, selecti

Latest News NDA News 464
Read All

FDA Approves Tofidence (tocilizumab-bavi), a Biosimilar to Actemra

CAMBRIDGE, Mass., Sept. 29, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi) intravenous formula

Latest News NDA News 493
Read All

FDA Approves Rivfloza (nedosiran) for the Treatment of Primary Hyperoxaluria Type 1 (PH1)

PLAINSBORO, N.J., Oct. 2, 2023 /PRNewswire/ -- Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved Rivfloza (nedosiran) injection 80 mg, 128 mg, or 160 mg, a onc

Latest News NDA News 638
Read All

FDA Approves Technegas (Technetium Tc 99-m Labeled Carbon) Radioactive Diagnostic Agent

October 2, 2023 -- Cyclopharm Limited (ASX: CYC) announces the company has received United States Food and Drug Administration (USFDA) approval to commence commercial sales of Technegas in the US mark

Latest News NDA News 764
Read All

FDA Approves Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) for the Treatment of Late-Onset Pompe Disease

PHILADELPHIA, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the U.S. Food and Drug Administration (FDA) has approved Pombiliti™ (cipaglucosidase alfa-atga)

Latest News NDA News 595
Read All

FDA Approves Ryzumvi (phentolamine) Ophthalmic Solution for the Treatment of Pharmacologically-Induced Mydriasis

FARMINGTON HILLS, Mich., and PITTSBURGH, Sept. 27, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commer

Latest News NDA News 604
Read All

FDA Approves Likmez (metronidazole) Oral Suspension for the Treatment of Parasitic and Anaerobic Bacterial Infections

HALIFAX, Nova Scotia--(BUSINESS WIRE) September 25, 2023 -- Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for i

Latest News NDA News 627
Read All

FDA Approves Ojjaara (momelotinib) for Myelofibrosis Patients with Anemia

Approval is for use in myelofibrosis patients with anemia regardless of prior myelofibrosis therapy Nearly all myelofibrosis patients are estimated to develop anemia over the course of the disease, an

Latest News NDA News 523
Read All

FDA Approves Aphexda (motixafortide) to Mobilize Hematopoietic Stem Cells for Autologous Transplantation in Patients with Multiple Myeloma

Aphexda is the first innovation in stem cell mobilization for multiple myeloma to be approved in the U.S. in a decade One dosage of Aphexda plus filgrastim enabled a majority of patients to achieve th

Latest News NDA News 531
Read All

FDA Approves Tyruko (natalizumab-sztn), a Biosimilar to Tysabri

August 24, 2023 -- The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing fo

Latest News NDA News 605
Read All
News
- CLINIEXPERT -
Int'l Clinical Service Expert

We are the leader
Because of our professionism