Shots: The approval is based on P-III DRIVE-FORWARD study assessing Pifeltro (qd) vs darunavir + ritonavir (DRV+r) (800mg, 100 mg, qd) each in combination with emtricitabine (FTC)/TDF or abacavir (ABC)/3TC […]readmore
Tags : receives
Shots: Post FDA approval in Aug 2017, Kymriah (tisagenlecleucel, formerly CTL019) receives EU approval for treatment of patients up to 25 years with (r/r), second or later stage in B-cell […]readmore
Shots: Post FDA approval in 2017, Yescarta (axicabtagene ciloleucel) receives EU marketing approval for the treatment of Relapsed or Refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell […]readmore
Regulatory
Tetraphase Pharmaceuticals’ Xerava (eravacycline) Receives FDA’s Approval for Complicated Intra-Abdominal
Shots: The approval is based on the two P-III IGNITE study assessing Xerava (eravacycline, bid, IV) vs ertapenem & meropenem in patients with cIAI The study demonstrated a non-inferiority data […]readmore
Shots: Teva’s EpiPen and EpiPen Jr (epinephrine) auto-injector will be used to treat allergic reaction including anaphylaxis in adults and pediatric patients weighing >33 pounds The US FDA approval is […]readmore
Biosimilars
Pharma
JHL Biotech’s Trastuzumab Biosimilar (JHL1188) Receives CHMP Positive Scientific Advice
Shots: JHL1188 gets CHMP approval for its global Phase III clinical trial in metastatic breast cancer JHL1188 is a proposed biosimilar to trastuzumab, which is marketed by Roche under the […]readmore
Shots: The approval is based on P-III FACET or Study 011 results assessing Galafold (150mg) in patient with Fabry Disease, evaluating its safety and efficacy The FACET or Study 011 […]readmore
Regulatory
Therapeutics MD’s Annovera (Segesterone Acetate/Ethinyl Estradiol) Receives FDA Approval for
Shots: The approval is based on 17 clinical trials results assessing Annovera in 2,308 women aged ≤35yrs The study demonstrated in prevention of 97.3% pregnancy, Pearl Index (PI) 2.98/100 women […]readmore
Shots: Arakoda the first preventive antimicrobial drug approved by FDA is for patients aged ≥18yrs The combined efforts of US Army and 60 Degree Pharma(60P) involving over 21 clinical trials […]readmore
Biosimilars
Pharma
Celltrion’s Herzuma (Herceptin biosimilar) Receives Marketing Approval in Australia
Shots: Herzuma is first biosimilar approved in Australia for the treatment of early breast cancer, locally advanced or metastatic or advance gastric cancer Including Herzuma Celltrion has three biosimilar for […]readmore