FDA Approves Nypozi (filgrastim-txid), a Biosimilar to Neupogen

FDA Approves Epysqli (eculizumab-aagh), a Biosimilar to Soliris

drugs.com - 22/Jul 20:07

INCHEON, South Korea, July 22, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has...

US FDA approves BioMarin's Brineura for children under 3 years with CLN2 disease

pharmabiz.com - 26/Jul 00:00

BioMarin Pharmaceutical Inc. announced that the US Food and Drug Administration (FDA) has approved the company's supplemental Biologics License...

FDA Approves Femlyv (norethindrone acetate and ethinyl estradiol) Orally Disintegrating Birth Control Pill

drugs.com - 23/Jul 23:07

On July 22, 2024, the U.S. Food and Drug Administration (FDA) approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally...

Manufacturing news briefs – stories you might have missed

aumanufacturing.com.au - 25/Jul 05:17

FDA accepts Mesoblast’s responses Biotech company Mesoblast has announced that the United States Food and Drug Administration (FDA) has accepted...

FDA Clears Investigational New Drug application for muscular dystrophy treatment

drugs.com - 18/Jul 00:07

MINNEAPOLIS and ST. PAUL, Minn., July 17, 2024. Today, Myogenica, a University of Minnesota startup company, announced U.S. Food and Drug...

Lexicon Pharmaceuticals Receives December 20, 2024 PDUFA Goal Date for Sotagliflozin Type 1 Diabetes NDA Resubmission

drugs.com - 16/Jul 21:07

The Woodlands, Texas, July 16, 2024 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that the U.S. Food and Drug Administration (FDA)...

Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease

drugs.com - 17/Jul 23:07

THOUSAND OAKS, Calif.--(BUSINESS WIRE) July 17, 2024 -- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its...

Merz Aesthetics Announces FDA Approval of Xeomin (incobotulinumtoxinA) as the First and Only U.S. Neurotoxin for the Simultaneous Treatment of Upper Facial Lines

drugs.com - 23/Jul 22:07

RALEIGH, NC – July 23, 2024 -- Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced today the U.S. Food...

FDA Approves Zituvimet XR (sitagliptin and metformin hydrochloride) Extended-Release Tablets for Adults with Type 2 Diabetes

drugs.com - 19/Jul 19:07

Ahmedabad, India, 19 July 2024 Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has...

FDA, FTC Continue Joint Effort to Protect Consumers Against Companies Illegally Selling Copycat Delta-8 THC Food Products

drugs.com - 16/Jul 08:19

Audience: Consumer July 16, 2024 -- Today, the U.S. Food and Drug Administration and the Federal Trade Commission (FTC) issued warning letters to five...

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