FDA Approves Immgolis (golimumab-sldi), an Interchangeable Biosimilar to Simponi

RALEIGH, N.C., May 18, 2026 /PRNewswire/ -- Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), focused on the development of oncolo

Latest News NDA News 586
• Read All

FDA Approves Immgolis Intri (golimumab-sldi), an Interchangeable Biosimilar to Simponi Aria (golimumab)

RALEIGH, N.C., May 18, 2026 /PRNewswire/ -- Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), focused on the development of oncolo

Latest News NDA News 464
• Read All

FDA Grants Accelerated Approval to Beqalzi (sonrotoclax) for Relapsed or Refractory Mantle Cell Lymphoma

SAN CARLOS, Calif. -- (BUSINESS WIRE) May 13, 2026 -- BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Adm

Latest News NDA News 490
• Read All

FDA Approves Veppanu (vepdegestrant) for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer

NEW HAVEN, Conn., May 01, 2026 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today with its partner Pfizer Inc. (NYSE: PFE), announced that the U.S. Food and Drug Administration (FDA) has granted

Latest News NDA News 1104
• Read All

FDA Approves Langlara (insulin glargine-aldy), an Interchangeable Biosimilar to Lantus

PHILADELPHIA -- May 4, 2026 -- Lannett Company, Inc., Lanexa Biologics, a wholly owned subsidiary of Lannett, and Sunshine Lake Pharma today announced that the U.S. Food and Drug Administration (FDA)

Latest News NDA News 608
• Read All

FDA Grants Accelerated Approval for Otarmeni (lunsotogene parvec-cwha) Gene Therapy for Genetic Hearing Loss

TARRYTOWN, N.Y., April 23, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Otar

Latest News NDA News 654
• Read All

FDA Approves Idvynso (doravirine and islatravir) for the Treatment of HIV-1 Infection in Adults

RAHWAY, N.J.--(BUSINESS WIRE) April 21, 2026 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved Idvyn

Latest News NDA News 642
• Read All

FDA Approves Foundayo (orforglipron), the Only GLP-1 Pill for Weight Loss That Can be Taken Any Time of Day Without Food or Water Restrictions

INDIANAPOLIS, April 1, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved Foundayo™ (orforglipron) for adults with obesity, or

Latest News NDA News 1692
• Read All

FDA Approves Ponlimsi (denosumab-adet), a Biosimilar to Prolia

TEL AVIV, Israel and PARSIPPANY, N.J., March 30, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the United States (U.S.) Food and Drug Administ

Latest News NDA News 895
• Read All

FDA Approves Awiqli (insulin icodec-abae) as the First and Only Once-Weekly Basal Insulin Treatment for Adults with Type 2 Diabetes

PLAINSBORO, N.J., March 26, 2026 /PRNewswire/ -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Awiqli (insulin icodec-abae) injection 700 units/mL, the first

Latest News NDA News 1366
• Read All

FDA Grants Accelerated Approval for Kresladi for the Treatment of Pediatric Patients with Severe Leukocyte Adhesion Deficiency-I (LAD-I)

CRANBURY, N.J.--(BUSINESS WIRE) -- Mar. 27, 2026 -- Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated biotechnology company advancing a sustainable pipeline of genetic therapies for rare

Latest News NDA News 738
• Read All

FDA Approves Lifyorli (relacorilant) Plus Nab-Paclitaxel for the Treatment of Patients with Platinum-Resistant Ovarian Cancer

REDWOOD CITY, Calif.--(BUSINESS WIRE) -- Mar. 25, 2026 -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat

Latest News NDA News 797
• Read All
News
- CanalLotus Biotech -
Int'l Clinical Service Expert

We are the leader
Because of our professionism