The Latest Breaking News from FDA

During the European Hematology Association (EHA) conference, Forma Therapeutics Holdings Inc (NASDAQ:FMTX) presented updated results from the 12-week open-label extension (OLE) of etavopivat's Phase 1 trial in sickle cell disease. Treatment with etavopivat 400mg QD elicited a >1g/dL hemoglobin (Hb) increase in 73% of the 15 patients and an average maximal Hb increase of…

Caribou Biosciences Inc (NASDAQ:CRBU) announced the presentation of additional initial clinical data from its ANTLER Phase 1 trial for CB-010 in relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL).  Following a single dose at the initial dose level of 40 million CAR-T cells, a 100% complete response (CR) rate (6 of 6…

The Canadian government has given its approval to AMX0035, a new drug from Cambridge, Massachusetts-based Amylyx Pharmaceuticals Inc.

The Australian regulatory authority has conditionally approved Novavax Inc's (NASDAQ:NVAX) Nuvaxovid (NVX-CoV2373) COVID-19 vaccine as a booster in individuals aged 18 and over. The provisional registration was based on data from Novavax's Phase 2 trial conducted in Australia, wherein a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after…

The FDA granted 510(k) clearance to Lensar Inc's (NASDAQ:LNSR) next-generation ALLY Adaptive Cataract Treatment System (ALLY System). ALLY is the first FDA-cleared platform to enable cataract surgeons to complete the femtosecond-laser-assisted cataract surgery (FLACS) procedure seamlessly in a single, sterile environment.  The company plans to deliver the first ALLY Systems to surgeons in Q3…

The FDA has denied NRx Pharmaceuticals Inc's (NASDAQ:NRXP) Breakthrough Therapy designation (BTD) request for Zyesami (aviptadil). The request for BTD was submitted based on a post-hoc subgroup analysis of patients who, in addition to aviptadil or placebo, were also treated with Gilead Sciences Inc's (NASDAQ: GILD) remdesivir and whose respiratory failure due to critical COVID-19 continued…

Shortages of vital, life-preserving goods are routine in America – and they’re the product of bad policy

Biotech stocks continued to be under pressure in the past week amid broader market weakness, precipitated by economic worries. Company-specific developments also triggered downward moves. Here's a compilation of five stocks that should be on your radar in the week of June 13: 1. Novavax

Regulators will evaluate both Pfizer-BioNTech and Moderna shots this week.

U.S. regulators have historically inspected baby formula plants at least once a year, but they did not inspect any of the three biggest manufacturers in 2020

U.S. Food and Drug Administration staff said that Pfizer Inc.’s COVID-19 shot was effective for kids ages 4 and under with no new safety concerns, in a report released ahead of a key meeting of FDA advisers later this week.