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Sanofi seeks FDA NDA approval for once-daily fixed-ratio combination of insulin glargine and lixisenatide

Sanofi seeks FDA NDA approval for once-daily fixed-ratio combination of insulin glargine and lixisenatide

EMA CHMP considers AcelRx's ARX-04 for acute pain treatment for centralized review

EMA CHMP considers AcelRx's ARX-04 for acute pain treatment for centralized review

CSL submits rIX-FP new drug application to Japan's Pharmaceuticals and Medical Devices Agency

CSL submits rIX-FP new drug application to Japan's Pharmaceuticals and Medical Devices Agency

Soligenix reports positive results from SGX942 Phase 2 trial in patients with head and neck cancer

Soligenix reports positive results from SGX942 Phase 2 trial in patients with head and neck cancer

TaiGen releases Taigexyn (nemonoxacin) capsules in Taiwan

TaiGen releases Taigexyn (nemonoxacin) capsules in Taiwan

Kitov Pharmaceuticals' KIT-302 drug candidate meets primary efficacy endpoint in Phase III clinical trial

Kitov Pharmaceuticals' KIT-302 drug candidate meets primary efficacy endpoint in Phase III clinical trial

Egalet submits NDA for ARYMO ER (morphine sulfate) extended-release tablets

Egalet submits NDA for ARYMO ER (morphine sulfate) extended-release tablets

FDA approves Teligent's sNDA for CEFOTAN (cefotetan) for Injection

FDA approves Teligent's sNDA for CEFOTAN (cefotetan) for Injection

FDA grants Fast Track status to Cardiorentis' Ularitide for treatment of ADHF

FDA grants Fast Track status to Cardiorentis' Ularitide for treatment of ADHF

Sinovac gets approval to begin clinical trials on Sabin Inactivated Polio Vaccine candidate

Sinovac gets approval to begin clinical trials on Sabin Inactivated Polio Vaccine candidate

Dompé’s investigational biotech molecule receives orphan drug designation for treatment of neurotrophic keratitis

Dompé’s investigational biotech molecule receives orphan drug designation for treatment of neurotrophic keratitis

Can-Fite BioPharma reports financial results, provides updates on drug development programs

Can-Fite BioPharma reports financial results, provides updates on drug development programs

Takeda receives FDA approval for NINLARO (ixazomib) capsules to treat patients with multiple myeloma

Takeda receives FDA approval for NINLARO (ixazomib) capsules to treat patients with multiple myeloma

Mylan releases Clozapine Orally Disintegrating Tablets in U.S.

Mylan releases Clozapine Orally Disintegrating Tablets in U.S.

Mylan announces U.S. launch of generic AXERT tablets

Mylan announces U.S. launch of generic AXERT tablets

Hutchison MediPharma begins sulfatinib Phase I trial in US

Hutchison MediPharma begins sulfatinib Phase I trial in US

Braeburn, Camurus announce FDA Fast Track designation for CAM2038 to treat opioid addiction

Braeburn, Camurus announce FDA Fast Track designation for CAM2038 to treat opioid addiction

Alnylam presents positive ongoing phase 2 open-label extension data for Patisiran and Revusiran

Alnylam presents positive ongoing phase 2 open-label extension data for Patisiran and Revusiran

Mylan announces U.S. launch of generic Fusilev for Injection

Mylan announces U.S. launch of generic Fusilev for Injection

Mast Therapeutics begins vepoloxamer Phase 2 study in patients with chronic heart failure

Mast Therapeutics begins vepoloxamer Phase 2 study in patients with chronic heart failure