Page 20 - Usfda

USFDA okays Biocon insulin Semglee as first interchangeable biosimilar drug

Semglee may now be substituted for Sanofi's Lantus by a pharmacist in the US

Caplin Point jumps 19%, hits record high; stock soars 37% in seven days

A combined 5.8 million equity shares, representing 7.6 per cent of the total equity of Caplin Point Laboratories, had changed hands on NSE and BSE till 12:56 pm

Zydus Cadila gets tentative approval from USFDA to market cancer drug

Drug firm Zydus Cadila on Wednesday said it has received tentative approval from the US health regulator to market Ibrutinib tablets used in the treatment of certain types of cancers.

Zydus gets USFDA nod to market generic HIV infection treatment tablets

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

US FDA okays arthritis drug for treatment of hospitalised Covid-19 patients

The US Food and Drug Administration has issued an emergency use authorization for the drug Actemra (tocilizumab) -- used for arthritis -- for the treatment of hospitalised patients with Covid-19.

Glenmark Pharma gets USFDA approval for generic lung cancer drug

Glenmark Pharmaceuticals said it has received approval from the US health regulator to market Nintedanib capsules, used in the treatment of idiopathic pulmonary fibrosis and non-small cell lung cancer

Lupin gets warning letter from US health regulator for Somerset facility

The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility, it said

Bharat Biotech to conduct additional clinical trials for USFDA nod

Timelines will be delayed; firm has received EUSs from 14 other countries

'BLA is standard process now': Bharat Bio on USFDA's EUA denial for Covaxin

The US regulator had earlier communicated that no new EUAs will be approved for Covid vaccines, says Hyderabad-based vaccine maker

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