New Drug Application News and Research

RSS
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.

Allergan announces positive results from AVYCAZ Phase III studies for treatment of cUTI

Allergan announces positive results from AVYCAZ Phase III studies for treatment of cUTI

FDA approves Allergan's sNDA to update label for TEFLARO (ceftaroline fosamil)

FDA approves Allergan's sNDA to update label for TEFLARO (ceftaroline fosamil)

Soligenix completes enrolment in SGX942 Phase 2 trial for oral mucositis in cancer patients

Soligenix completes enrolment in SGX942 Phase 2 trial for oral mucositis in cancer patients

HPPI commences enrollment for Phase II(b) SCORING clinical trial for cancer treatment

HPPI commences enrollment for Phase II(b) SCORING clinical trial for cancer treatment

Valeant enters into definitive agreement to acquire Sprout Pharmaceuticals

Valeant enters into definitive agreement to acquire Sprout Pharmaceuticals

AbbVie’s subsidiary to acquire United Therapeutics’ Rare Pediatric Disease Priority Review Voucher

AbbVie’s subsidiary to acquire United Therapeutics’ Rare Pediatric Disease Priority Review Voucher

TapImmune announces successful conveyance of Investigational New Drug Application from Mayo Clinic

TapImmune announces successful conveyance of Investigational New Drug Application from Mayo Clinic

Mylan sued in connection with ANDA filing for generic version of Zytiga

Mylan sued in connection with ANDA filing for generic version of Zytiga

New OTEMTO phase three results show potential improvement to quality of life for COPD patients

New OTEMTO phase three results show potential improvement to quality of life for COPD patients

Omeros plans to file patent infringement lawsuit against Par

Omeros plans to file patent infringement lawsuit against Par

FDA accepts Chiasma's NDA filing for octreotide capsules for treatment of adult patients with acromegaly

FDA accepts Chiasma's NDA filing for octreotide capsules for treatment of adult patients with acromegaly

Neurocrine completes enrollment in Phase III clinical trial of NBI-98854 in tardive dyskinesia patients

Neurocrine completes enrollment in Phase III clinical trial of NBI-98854 in tardive dyskinesia patients