Page 21 - Usfda

Moderna begins process for full USFDA approval for its vaccine use

American pharmaceutical company Moderna says it has begun the process to win full US regulatory approval for the use of its COVID-19 vaccine in adults.

Moderna seeks full USFDA approval for its coronavirus vaccine for adults

American pharmaceutical company Moderna says it has begun the process to win full US regulatory approval for the use of its COVID-19 vaccine in adults

Everest Organics up 20% on launching Posaconazole API to treat Black Fungus

Posaconazole is a triazole antifungal agent indicated for treating mucormycosis patients popularly known as Black Fungus

Unichem Labs gets USFDA nod to market generic antidepressant tablets

Drug firm Unichem Laboratories on Thursday said it has received approval from the US health regulator to market generic Amitriptyline HCl tablets used in the treatment of depression. The company has received abbreviated new drug application (ANDA) approval to market its Amitriptyline HCl tablets USP, in the strengths of 10 mg, 25 mg, 50 mg, 75 mg, 100 mg and 150 mg from the United States Food and Drug Administration (USFDA), Unichem Laboratories said in a regulatory filing. The product is a generic version of AstraZeneca Pharmaceuticals LP's Elavil tablets in the same strengths, it added. The tablets will be commercialised from the company's Goa plant, Unichem Labs said. Amitriptyline HCl Tablets are indicated for the relief of symptoms of depression, it added. Shares of Unichem Laboratories closed at Rs 358.60 per scrip on BSE, up 7.43 per cent from its previous close.

Should my child get coronavirus vaccine? 7 questions answered by an expert

US FDA has expanded emergency use authorization of the Pfizer-BioNTech Covid-19 vaccine to include adolescents 12 to 15 years of age

Pfizer aims for full FDA approval of Covid vaccine for people 16 and above

Pfizer Chief Executive Albert Bourla said in a statement that the companies are aiming to win full regulatory approval in the coming months

Lilly hit by staff accusations, FDA scrutiny at Covid-19 drug factories

(Reuters) - Eli Lilly & Co employees have accused a factory executive of altering documents required by government regulators in an effort to downplay serious quality control problems at the U.S. plant producing the drugmaker's COVID-19 treatment, according to an internal Lilly complaint and a source familiar with the matter.

Drug maker Caplin Steriles gets USFDA approval for an injection

The injection is used for short-term intravenous treatment of patients with acute decompensated heart failure

US weighs next steps for J&J virus shot amid clot mystery

U.S. health officials are weighing next steps as they investigate a handful of unusual blood clots in people who received Johnson&Johnson's COVID-19 vaccine a one-dose shot that many countries were eagerly awaiting to help speed virus protection. It's not clear if the exceedingly rare reports so far, six cases out of more than 7 million inoculations in the U.S. really are linked to the J&J vaccine. But the government recommended a pause in J&J vaccinations on Tuesday, just a week after European regulators declared that such clots are a rare but possible risk with the AstraZeneca vaccine, a shot made in a similar way but not yet approved for use in the U.S. The clots occurred in strange places, in veins that drain blood from the brain, and in people with abnormally low levels of clot-forming platelets. The six cases raised an alarm bell because that number is at least three times more than experts would have expected to see even of more typical brain-drainage clots, said

India fast-tracks emergency use of foreign-made Covid-19 vaccines

No need for prior local clinical trials for vaccines cleared by regulators

US calls for pause on J&J's Covid-19 vaccine after 6 clotting cases

The USFDA said one person had died from the rare blood clotting condition after taking the J&J vaccine and another was in a critical condition

USFDA authorises two changes to Moderna's vaccine against coronavirus

The US Food and Drug Administration has authorised two changes to Moderna's Covid-19 vaccine that can provide extra doses from each vial

Zydus Cadila receives tentative nod from USFDA to market two HIV drugs

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ Ahmedabad

This pharma stock has zoomed over 10,000% in 96 trading days

Orchid Pharma shares were locked in the upper circuit for the 96th straight trading day

Cipla receives USFDA nod for nasal spray for treating migraine attacks

Drug major Cipla on Tuesday said it has received final approval from the United States Food and Drug Administration (USFDA) for Sumatriptan Nasal Spray, indicated for the treatment of migraine attacks

FDA advisory panel to review J&J Covid-19 vaccine with thumbs up expected

(Reuters) - A panel of expert advisers to the U.S. Food and Drug Administration began a meeting to discuss Johnson & Johnson's one-dose COVID-19 vaccine on Friday, setting the stage for a possible emergency use authorization as early as this week.

FDA says single-dose shot from J&J vaccine prevents severe Covid-19

Johnson & Johnson's single-dose vaccine offers strong protection against severe COVID-19, according to an analysis released by US regulators that sets the stage for a final decision on a new and easier-to-use shot to help tame the pandemic. The long-anticipated shot could offer the nation a third vaccine option and help speed vaccinations by requiring just one dose instead of two. Food and Drug Administration scientists on Wednesday confirmed that overall the vaccine is about 66% effective at preventing moderate to severe COVID-19, and about 85% effective against the most serious illness. The agency also said J&J's shot is safe. The analysis is just one step in the FDA's evaluation. On Friday, the agency's independent advisers will debate if the evidence is strong enough to recommend the shot. With that advice, the FDA is expected to make a final decision within days. The COVID-19 death toll in the US topped 500,000 this week, and the vaccination drive has been slower than ...

Dr Reddy's launches stomach, esophagus problems treatment drug in US

The product is a therapeutic equivalent generic version of Prevacid SoluTab delayed release orally disintegrating tablets approved by the US Food and Drug Administration (USFDA)

Zydus Cadila gets USFDA final nod for low blood pressure drug Droxidopa

The newly approved medication will be manufactured at the group''s formulation manufacturing facility at SEZ, Ahmedabad

Weak US outlook in near term, higher costs to weigh on Torrent Pharma

While the stock has corrected, valuations leave little room for upside