October 31, 2016
Sanofi submits corrective action plan to the FDA regarding the BLA for sarilumab
Sanofi and Regeneron Pharmaceuticals have announced the FDA issued a Complete Response Letter (CRL) regarding…
Pharmaceuticals, Biotechnology and Life Sciences
Category: Approval
October 31, 2016
Allergan’s chronic dry eye drops will make patients shed more tears
Allergan has received approval from the FDA for Restasis, treatment to help patients with a type of Chronic Dry Eye …
October 31, 2016
Finnish patent office accepts Faron’s new formulation for a respiratory orphan disease ARDS
Finish patent office has accepts Faron’s new formulation for a respiratory orphan disease ARDS
October 28, 2016
Futura to produce extended shelf life condoms
Futura Medical has gotten EU approval to manufacture CSD500, the company’s novel, erectogenic condom
October 27, 2016
Allergan to close down buying Motus, relamorelin goes to Phase 3 tests
Allergan on Thursday announced the results of Phase 2b study of the new gastroparesis…
October 25, 2016
Bangladesh’s Beximco gets its second US FDA product approval
Bangladesh-based Beximco, the largest country’s pharmaceutcals exporter, has received its second US FDA …
October 24, 2016
Astellas’s and Pfizer’s cancer drug gets new product label data
Astellas Pharma and Pfizer have announced the FDA approved a supplemental New …
October 24, 2016
FDA gives green light to Merck’s CDI drug
The US FDA has approved Merck’s Zinplava (bezlotoxumab) Injection 25 mg/mL, which …
October 24, 2016
GSK applies to FDA for zoster vaccine
GlaxoSmithKline has submitted a Biologics License Application (BLA) for its candidate shingles vaccine, ShingrixTM, to the United States Food and Drug Administration (FDA).
October 20, 2016
FDA approves Lilly’s Lartruv for soft tissue sarcoma treatment
Eli Lilly and Company announced that FDA has granted approval of LARTRUV (olaratumab injection, 10 mg/mL), in combination with doxorubicin, for the treatment of adults with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.