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Teijin Completes Acquisition of Renegade

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for investigational agent bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma.

August 2nd, 2019|News|

FDA grants Opdivo combo Breakthrough Designation for melanoma

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for investigational agent bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma.

August 2nd, 2019|News|

Mississippi Lime Completes Acquisition of Southern Lime, Begins Integration of the Calera, Alabama based Business

a leading global supplier of high-calcium lime products and a portfolio company of HBM Holdings, today announced it has completed its acquisition of the Calera, Alabama lime business of Covia (NYSE: CVIA), operating historically as Southern Lime.

August 1st, 2019|News|

Nubeqa bags FDA green light

The US Food and Drug Administration (FDA) has approved Eli Lilly’s non-steroidal androgen receptor inhibitor (ARi), Nubeqa (darolutamide), for men with non-metastatic castration-resistant prostate cancer.

July 31st, 2019|News|

Xpovio combo bags FDA approval for refractory multiple myeloma

The US Food and Drug Administration (FDA) has granted accelerated approval to a new corticosteroid dexamethasone, Xpovio (selinexor) combo.

July 5th, 2019|News|

Nucala (mepolizumab) gains FDA approval for two new self-administration options

GlaxoSmithKline (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved two new methods for administering Nucala (mepolizumab), an autoinjector and a pre-filled safety syringe, for patients or caregivers to administer once every four weeks, after a healthcare professional decides it is appropriate.

June 7th, 2019|News|

FDA approval for Novartis’ Piqray

Novartis’ Piqray (alpelisib) has been approved by the US Food and Drug Administration (FDA) in combination with fulvestrant for the treatment of postmenopausal women and men with HR+ and HER2- PIK3CA-mutated, advanced or metastatic breast cancer.

May 28th, 2019|News|

FDA approval for Bavencio combo in advanced RCC

The US Food and Drug Administration (FDA) has approved Merck’s Bavencio (avelumab) plus Inlyta (axitinib) combination for patients with advanced renal cell carcinoma.

May 15th, 2019|News|

ViiV submits NDA for first long-acting, injectable HIV combo

ViiV Healthcare has submitted a new drug application to the US Food and Drug Administration (FDA) for the first ever monthly, injectable, two-drug regimen of cabotegravir and Edurant (rilpivirine) for treatment of HIV.

May 1st, 2019|News|

Bayer, Orion win FDA priority review for darolutamide in prostate cancer

The US Food and Drug Administration (FDA) has accepted a new drug application for review and granted priority review for darolutamide.

May 1st, 2019|News|