Industry News

- Read more about Agile Therapeutics initiate phase 2 study of once weekly contraceptive Twirla
Agile Therapeutics, Inc., a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, announced that preparations are underway for an initial Phase 2 clinical trial of a novel contraceptive regimen, which will begin the development of its pipeline beyond its current lead product candidate, Twirla®, a once weekly contraceptive patch currently in phase 3 development. The planned Phase 2 clinical trial will examine the use of Twirla in an innovative regimen designed to allow women to experience shorter, lighter periods.
- Read more about FDA approves first intraocular lens for cataract patients
The U.S. Food and Drug Administration approved the first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual acuity) at near, intermediate and far distances. The Tecnis Symfony Extended Range of Vision IOL is manufactured by Abbott Medical Optics, Inc. of Santa Ana, California.
- Read more about Oncternal Therapeutics' TK216 get US FDA Orphan Drug status for Ewing sarcoma
Oncternal Therapeutics, Inc., a clinical-stage oncology company developing first-in-class therapies for rare and common malignancies, announced that TK216 has received Orphan Drug designation from the US Food and Drug Administration (FDA) for the treatment of Ewing sarcoma.
- Read more about Amgen & Daiichi Sankyo collaborate to Commercialize Biosimilars In Japan
Amgen and Daiichi Sankyo Company, Limited announced the execution of an exclusive agreement to commercialize nine biosimilars in Japan. The deal includes several biosimilars in late-stage development, including biosimilars of adalimumab, bevacizumab and trastuzumab.
- Read more about Loxo Oncology Get Breakthrough Therapy Designation from U.S. FDA for LOXO-101
Loxo Oncology, Inc, a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK), “for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments.”
- Read more about US FDA advisory committee review Amgen's BLA for ABP 501
Amgen announced that the company will discuss data supporting the ABP 501 Biologics License Application (BLA) with the US Food and Drug Administration's (FDA) Arthritis Advisory Committee. ABP 501 is a biosimilar candidate to Humira (adalimumab), an anti-tumour necrosis factor-alpha (TNF-a) monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases.
- Read more about FDA Approve Cohera Medical Inc to Begin Trials of its Sylys® Surgical Sealant in the U.S.
Cohera Medical, Inc., a leading innovator and developer of absorbable surgical adhesives and sealants, announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) to begin a prospective, multicenter, randomized clinical trial for its Sylys® Surgical Sealant device.
- Read more about Health Canada grant InVivo Therapeutic’s Investigational Testing Authorization
InVivo Therapeutics Holdings Corp. announced that Health Canada has approved the company’s Investigational Testing Authorization application to commence clinical studies in Canada. The authorization will allow the company to enroll Canadian patients into the ongoing INSPIRE study once a Canadian site is open for enrollment. InVivo currently is in late stage conversation with various Canadian Research Ethics Boards and expects to announce its first Canadian site in the coming weeks.

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- Read more about iBio Inc. Receives FDA Orphan Drug Designation for iBio-CFB03
iBio, Inc. a leading provider of plant-based biotechnology for developing and manufacturing biological products, announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to iBio's investigational biotherapeutic product, iBio-CFB03, for the treatment of systemic sclerosis.
- Read more about Medtronic Get FDA Approval for IN.PACT Admiral DCB, 150 mm Lengths
Medtronic plc has received U.S. Food and Drug Administration (FDA) approval for the IN.PACT Admiral drug-coated balloon (DCB) in longer, 150 mm lengths. The new 150 mm length balloon, available in four, five, and six mm diameters, will provide greater treatment options for long lesions in patients with peripheral artery disease (PAD).