New Drug Application News and Research

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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

First patients screened in Axovant's phase 3 study of RVT-101

First patients screened in Axovant's phase 3 study of RVT-101

AcelRx Pharmaceuticals initiates ARX-04 Phase 3 study in emergency room patients with acute pain

AcelRx Pharmaceuticals initiates ARX-04 Phase 3 study in emergency room patients with acute pain

FDA accepts Braeburn's resubmission of Probuphine NDA for review

FDA accepts Braeburn's resubmission of Probuphine NDA for review

Mylan releases generic version of Invega in the U.S.

Mylan releases generic version of Invega in the U.S.

Kolltan announces presentation of data from KTN0158 preclinical study in mast cell tumors at ESMO 2015

Kolltan announces presentation of data from KTN0158 preclinical study in mast cell tumors at ESMO 2015

Novo Nordisk announces FDA approval of Tresiba (insulin degludec injection) for diabetes treatment

Novo Nordisk announces FDA approval of Tresiba (insulin degludec injection) for diabetes treatment

Study explores effectiveness of frontline treatments for couples with unexplained infertility

Study explores effectiveness of frontline treatments for couples with unexplained infertility

FDA approves Impax Laboratories' generic version of Testred Capsules 10 mg

FDA approves Impax Laboratories' generic version of Testred Capsules 10 mg

Mylan releases Fluvastatin Sodium Extended-release Tablets in the U.S.

Mylan releases Fluvastatin Sodium Extended-release Tablets in the U.S.

Allergan settles patent litigation with Amneal related to NAMENDA XR extended release capsules

Allergan settles patent litigation with Amneal related to NAMENDA XR extended release capsules

AcelRx's ARX-04 meets primary and secondary endpoints in Phase 3 trial

AcelRx's ARX-04 meets primary and secondary endpoints in Phase 3 trial

FDA grants Orphan Drug designation to Rigel's Fostamatinib for treatment of patients with ITP

FDA grants Orphan Drug designation to Rigel's Fostamatinib for treatment of patients with ITP

Mylan releases generic version of Yasmin Tablets in the U.S.

Mylan releases generic version of Yasmin Tablets in the U.S.