New Drug Application News and Research

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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

Sinovac Dalian receives approval to start human clinical trials of varicella vaccine candidate

Sinovac Dalian receives approval to start human clinical trials of varicella vaccine candidate

Breakthrough research suggests that female sex hormone may save lives on the battlefield

Breakthrough research suggests that female sex hormone may save lives on the battlefield

TARSA Therapeutics' TBRIA NDA accepted by FDA for review

TARSA Therapeutics' TBRIA NDA accepted by FDA for review

BDSI announces FDA approval of BUNAVAIL sNDA for manufacturing specification change

BDSI announces FDA approval of BUNAVAIL sNDA for manufacturing specification change

AcelRx provides update on Zalviso (sufentanil sublingual tablet system)

AcelRx provides update on Zalviso (sufentanil sublingual tablet system)

Neurocrine Biosciences announces positive data from NBI-98854 Phase III trial in tardive dyskinesia

Neurocrine Biosciences announces positive data from NBI-98854 Phase III trial in tardive dyskinesia

Immune submits Bertilimumab IND application to FDA for treatment of Bullous Pemphigoid

Immune submits Bertilimumab IND application to FDA for treatment of Bullous Pemphigoid