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The Latest Breaking News from FDA

Citi Research has raised the price target on Amylyx Pharmaceuticals Inc's (NASDAQ:AMLX) to $33 from $32, with a Buy rating. It says the small market opportunity for the newly approved amyotrophic lateral sclerosis (ALS) drug in Canada (~$100 million peak) bodes well for ongoing FDA review. Availability in Canada and using ALSFRS-R data as the primary basis…

Benzinga

Approval Of Baricitinib For Patchy Baldness Validates Clinical Patch For This Small-Cap Stock

Olumiant (baricitinib), a Janus kinase (JAK) inhibitor, was developed by Incyte Corp (NASDAQ:INCY) and launched in collaboration with Eli Lilly And Co (NYSE:LLY), received FDA approval for hair loss disorder known as alopecia areata (AA). Olumiant was first approved for the treatment of rheumatoid arthritis (RA) in 2018. The above nod is expected to…

Benzinga

Moderna's COVID-19 Shot Likely Related To Higher Heart Inflammation Risk Than Pfizer's: Reuters

Moderna Inc's (NASDAQ:MRNA) COVID-19 vaccine may relate to a higher risk of heart inflammation in some age groups than Pfizer Inc (NYSE:PFE) - BioNTech SE's (NASDAQ:BNTX) shot, Reuters reported citing the Centers for Disease Control and Prevention. Citing recent data, CDC said that the findings on myocarditis and pericarditis, types of heart inflammation linked to both the…

Benzinga

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FDA advisers consider Moderna's COVID shots for older kids

A government advisory panel is meeting to decide whether to recommend a second brand of COVID-19 vaccine for school-age children and teens

The Independent UK

FDA OKs Apple Watch To Help Monitor Symptoms Of Parkinson's Disease

A San Francisco-based software company received permission from the U.S. Food and Drug Administration to use Apple Inc. (NASDAQ: AAPL) wearable technology to track Parkinson's symptoms.

Benzinga

The Daily Biotech Pulse: FDA Nod For Lilly-Incyte's Patchy Hair Loss Treatment, First Regulatory Submission For EQRx, Soleno's Promising Data From Prader-Willi Candidate

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

Morning Brief: Top Financial Stories Dominating on Tuesday, June 14

CNBC

Benzinga

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Why Outset Medical Shares Are Trading Lower Today

Outset Medical Inc (NASDAQ:OM) implemented a shipment hold on the distribution of its Tablo Hemodialysis System for home use pending the FDA review and clearance of a 510(k). The company submitted for changes made since the device's original March 2020 clearance. Outset has not identified any safety issues with Tablo. It will continue…

Benzinga

Editorial: Needed action on menthol cigarette ban

Three generations of LaTrisha Vetaw's family have smoked menthol cigarettes. It might even be four, since Vetaw knows that her great-grandfather smoked but isn't sure what brand he lit up.

Tribune News Service

Lilly-Incyte Snag FDA Nod For Patchy Hair Loss Treatment — Smaller Rival's Stock Shoots Up In Sympathy

Alopecia areata, an autoimmune disorder that causes patchy hair loss, now has a new treatment that has been approved by the Food and Drug Administration.

Benzinga

Editorial: The FDA is right to ban menthol cigarettes

Take a deep breath, America. We’ve made serious progress against cigarette smoking. According to the U.S. Centers for Disease Control and Prevention, 23% of adults were smokers in 2000. By 2020, the rate had fallen to 12.5%. Teen use of traditional cigarettes has plummeted from 22.5% in 2002 to 6%…

Los Angeles Times

Alnylam's Stock Gains Following FDA Nod For hATTR Amyloidosis Candidate

The U.S. Food and Drug Administration (FDA) approved Alnylam Pharmaceuticals’ (NASDAQ: ALNY) lead drug candidate AMVUTTRA (Vutrisiran) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.

Benzinga

Read Why Forma Therapeutics' Current Price Level Is 'Attractive Entry Point'

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…

Benzinga

Analysts Remain Bullish Despite Caribou's Allogeneic CAR-T Hit By Durability

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…

Benzinga

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news in one place.

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Benzinga

Canada Approves Amylyx's ALS Drug; FDA To Consider Approval In September

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

Benzinga

Novavax' Sees Conditional Approval Of COVID-19 Vaccine Booster In Australia As US FDA Delays Its Decision

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…

Benzinga

Why Lensar Shares Are Trading Higher Today

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…

Benzinga

What's Next For NRx Pharma As FDA Denies Breakthrough Therapy Tag For COVID-19 Therapy

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…

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The Guardian - US

The US baby formula shortage isn’t bad luck. It was completely preventable

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

Benzinga

5 Biotech Stocks To Watch During The Week Of June 13

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

Axios

The youngest Americans may finally get their COVID shots

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

The Independent UK

Many baby formula plants weren't inspected because of COVID

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

Tribune News Service

Pfizer COVID shot works, safe for youngest kids, FDA says

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.

The Independent UK

US: Pfizer COVID-19 appears effective for kids under 5

A review by federal health officials says that Pfizer's COVID-19 vaccine appears safe and effective for children under 5, the only group not currently eligible for vaccination

ABC News

Why the world's still waiting for a dementia cure, and what we can do in the meantime

Many researchers agree that Alzheimer's disease actually starts decades before thinking and memory start to decline. What can we do about it?

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