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The Latest Breaking News from FDA

This Microcap Pharma Stock Almost Doubled Today - Read Why

UnitedHealthcare has added Kala Pharmaceuticals Inc's (NASDAQ:KALA) Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% as a covered brand on its commercial formularies effective March 2022. Eysuvis now has coverage for approximately 118 million lives or 70% of all commercial lives. Kala also announced that Cigna Medicare had added Eysuvis as a preferred brand effective…

Benzinga

Congress Seems Poised To Let the FDA Ban E-Cigarettes Containing Synthetic Nicotine

A spending bill provision would redefine "tobacco products" to include products that have nothing to do with tobacco.

Reason

Read Why Valneva's Stock Gained 7% Today

Valneva SE (NASDAQ:VALN) completed the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553. Valneva posted topline results from the phase 3 trial in August last year. The primary endpoint result is mainly unchanged from that data drop. The removal of two subjects from the analysis increased the proportion of participants with protective…

Benzinga

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Why Owlet Shares Are Trading Lower Today

Owlet Inc (NYSE:OWLT) reported FY21 sales of 75.8 million, just 0.6% higher than the $75.4 million reported a year ago. The Company noted that through the first three quarters of 2021, revenues were $78.4 million, up 44% Y/Y, but early in Q4 FY21, Owlet received an FDA Warning Letter, resulting in halting sales…

Benzinga

The Daily Biotech Pulse: Moderna Outlines Steps For mRNA Tech Advancement, Voyager-Novartis Strike Licensing Deal, Valneva Reports Positive Chikungunya Shot Readout

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

Benzinga

Can the FDA's New Commissioner Save the Agency From Itself?

Robert Califf must demand transparency and accountability from the bureaucrats.

Reason

FDA Gives Green Signal To Inventiva's Mid-Stage Lanifibranor Study In NASH Patients

The FDA has completed a safety review of Inventiva SA's (NASDAQ: IVA) IND application and

Benzinga

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FDA Approves Axonics' Recharge-Free Sacral Neuromodulation System

The

Benzinga

Gene-edited beef cattle get regulatory clearance in U.S.

Meat from gene-edited cattle could be on the way in a few years

The Hindu

Lung-Disease Focused AN2 Therapeutics Files Plans For NASDAQ Debut

AN2 Therapeutics Inc filed plans on Friday to go public in an initial public offering in which it reportedly hopes to raise about $75 million. AN2 plans to list on the Nasdaq with the symbol of ANTX. The Menlo Park-based biotech is developing a therapy for non-tuberculous mycobacterial (NTM) lung disease, which…

Benzinga

LAVA Therapeutics Shares Interim LAVA-051 Data From Early-Stage Cancer Trial

LAVA Therapeutics NV (NASDAQ:LVTX) announced initial data from its first clinical study with LAVA-051. The presentation will include data from the first three cohorts of the LAVA-051 Phase 1/2a trial, along with preclinical data on its two lead programs, LAVA-051 and LAVA-1207. The first three dose-escalation cohorts showed LAVA-051 to be safe and…

Benzinga

Why Alpine Immune's Shares Are Falling Today

The FDA has placed a partial clinical hold on Alpine Immune Sciences Inc's (NASDAQ:ALPN) NEON-2 trial evaluating davoceticept (ALPN-202) in combination with pembrolizumab in adults with advanced malignancies. The partial clinical hold was prompted by Alpine's report of patient death in the NEON-2 trial. The participant had choroidal melanoma previously treated with nivolumab and…

Benzinga

NOVN: A Banner Year for Novan - 2021 Results

By John Vandermosten, CFA NASDAQ:NOVN READ THE FULL NOVN RESEARCH REPORT

Benzinga

Is Ra Medical Systems a Good Penny Stock to Own?

The shares of commercial-stage medical device maker Ra Medical Systems (RMED) have tumbled 92.7% in price over the past year due to investor concerns surrounding the company’s poor financial health. Also, given the uncertainty surrounding the FDA’s approval of its DABRA catheter laser system, the question becomes, is the penny…

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Zenger

Electrical Stimulation Zaps Premature Ejaculation

FDA-approved vPatch can prolong the time to orgasm by a factor of three and a half. The disposable patch will cost about $15.

Bangkok Post

Local Covid vaccines undergo human trials

Four out of more than 20 Covid-19 vaccine candidates being developed in Thailand are now being tested on humans, the final process required before they are submitted for approval by the Food and Drug Administration (FDA), the government said on Saturday.

Benzinga

Analysts Move To Sidelines On Vicarious Surgical After Regulatory Update

Piper Sandler has downgraded Vicarious Surgical Inc (NASDAQ:RBOT) to Neutral from Overweight with a price target of $7, down from $16, below expected Q4 results. A majority of the earnings call focused on the Company's regulatory update. Vicarious announced its plans to pursue a De Novo FDA pathway, including a pre-market study, for its…

Benzinga

Analysts Cut Price Target On Aziyo Biologics As Q4 Earnings Fall Short Of Expectations

Aziyo Biologics Inc (NASDAQ:AZYO) Q4 FY21 sales decreased 13% to $10.9 million, missing the consensus of $11.06 million. Excluding the contribution of FiberCel sales, which the product's distributor discontinued in Q2 of 2021, Q4 sales increased 6% Y/Y. The 510(k) application for CanGaroo RM, the Company's next-generation envelope, remains on track for submission…

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Benzinga

Despite More Than Double Q4 Sales, Chembio Diagnostics Posts Deeper Losses

Chembio Diagnostics Inc's (NASDAQ:CEMI) Q4 sales increased 101% Y/Y to $20.6 million, beating the consensus of $13.55 million. Net product sales increased 154% to $17.4 million. Government grant, license, and royalty, and R&D revenue totaled $3.2 million, down 6%. Chembio posted a wider operating loss of $(13.97) million, compared to $(7.14) million…

Los Angeles Times

The FDA is approving more drugs that haven’t been shown to work. Are patients being harmed?

LOS ANGELES — Federal regulators are increasingly approving medicines before studies have shown they work, leaving patients at risk of taking prescriptions that could harm but not help them.

Benzinga

FDA Denies Pediatric EUA To Ocugen For Bharat Biotech's COVID-19 Vaccine Covaxin

The FDA has declined to issue an Emergency Use Authorization (EUA) for Covaxin for active immunization to prevent COVID-19 in individuals 2 to 18 years of age. Ocugen Inc (NASDAQ:OCGN) is working with the vaccine's developer, Bharat Biotech of India, to bring Covaxin to the U.S. Related: FDA Lifts Clinical Hold On Ocugen's COVID-19…

Benzinga

Why Ocugen Shares Are Falling

Ocugen Inc (NASDAQ: OCGN) shares are trading lower by 22.8% at $2.54 after the company announced the FDA declined to issue an EUA for COVAXIN for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 2 to 18 years of age.

Benzinga

24 Stocks Moving in Friday's Pre-Market Session

Gainers Statera Biopharma, Inc. (NASDAQ: STAB) rose 30.4% to $0.9520 in pre-market trading. Statera Biopharma recently submitted Phase 1 clinical trial protocol to the FDA for investigational treatment of long-haul COVID-19.

Benzinga

Tonix Pharmaceuticals Rockets Higher Thursday: Why Is The Penny Stock Flying?

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) shares are rallying higher Thursday after the company announced the FDA has granted Orphan-Drug Designation for TNX-2900 for the treatment of Prader-Willi syndrome.

Benzinga

FDA Pushes TG Therapeutics' Ublituximab / Ukoniq Combo Therapy Applications In Blood Cancer Settings

The FDA has extended the review period of TG Therapeutics Inc's (NASDAQ:TGTX) biologics license application and supplemental New Drug Application for ublituximab in combination with Ukoniq (umbralisib) for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The Prescription Drug User Fee Act (PDUFA) goal date is postponed to June 25. The FDA notified…

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