Tag: US Food and Drug Administration

Zydus Lifesciences gets FDA approval for Bortezomib for Injection

businessnewstoday- May 3, 2022 0

Zydus Lifesciences (previously called Cadila Healthcare) said that it has secured final approval from the US Food and Drug Administration (FDA) to market Bortezomib for ... Read More

Dr. Reddy’s Labs launches Posaconazole Delayed-Release Tablets in US

businessnewstoday- April 20, 2022 0

Dr. Reddy’s Laboratories said that it has launched Posaconazole Delayed-Release Tablets, 100 mg, a triazole antifungal drug, in the US market. Posaconazole Delayed-Release Tablets is ... Read More

BriaCell Therapeutics’ Bria-IMT gets FDA fast track status in breast cancer

businessnewstoday- April 15, 2022 0

BriaCell Therapeutics has secured the fast track status from the US Food and Drug Administration (FDA) for its lead candidate — Bria-IMT for the treatment ... Read More

Axsome Therapeutics to acquire Sunosi from Jazz Pharmaceuticals

businessnewstoday- March 29, 2022 0

Axsome Therapeutics has agreed to acquire Sunosi (solriamfetol), an approved dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), from Jazz Pharmaceuticals. Sunosi is indicated to improve ... Read More

Pfizer RSVpreF vaccine candidate gets another FDA breakthrough therapy status

businessnewstoday- March 27, 2022 0

Pfizer said that PF-06928316 (RSVpreF), its respiratory syncytial virus (RSV) vaccine candidate, has been granted breakthrough therapy designation from the US Food and Drug Administration ... Read More

FDA rejects Lilly’s sintilimab as first line treatment of NSCLC

businessnewstoday- March 27, 2022 0

The US Food and Drug Administration (FDA) has rejected the biologics license application (BLA) of Eli Lilly and Company (Lilly)’s sintilimab injection in nonsquamous non-small ... Read More

FDA refuses to approve AstraZeneca’s sBLA for Fasenra in CRSwNP

businessnewstoday- March 19, 2022 0

The US Food and Drug Administration (FDA) has refused to approve the supplemental biologics license application (sBLA) of AstraZeneca’s asthma drug Fasenra (benralizumab) for the ... Read More

Lupin gets FDA approval for Vigabatrin for Oral Solution USP, 500 mg

businessnewstoday- March 12, 2022 0

Lupin Limited said that it has secured approval for Vigabatrin for Oral Solution USP, 500 mg, an anti-epileptic drug, from the US Food and Drug ... Read More

Harpoon Therapeutics gets FDA fast track status for HPN217 in RRMM

businessnewstoday- March 5, 2022 0

Harpoon Therapeutics has bagged fast track designation for HPN217 from the US Food and Drug Administration (FDA) for the treatment of certain patient population with ... Read More

Pfizer gets FDA breakthrough status for RSVpreF RSV vaccine candidate

businessnewstoday- March 5, 2022 0

Pfizer has secured breakthrough therapy designation for its respiratory syncytial virus (RSV) vaccine candidate — PF-06928316 (RSVpreF) from the US Food and Drug Administration (FDA) ... Read More